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☐ ☆ ✇ BMJ Open

Trends and factors associated with previous induced abortions among young women in Foshan, China: insights from a retrospective cross-sectional study

Por: Ou · Y. · Chokkakula · S. · Chong · S. · Wang · H. · Liu · S. · Si · A. I.-C. · Pathakumari · B. · Lyu · J. · Yin · C. · Ye · X. · Huang · X. — Abril 2nd 2026 at 16:50
Objectives

This study aims to explore the history of prior abortions and the factors influencing them among young women seeking abortion services in Foshan, Guangdong, China.

Design

This is a retrospective, cross-sectional study of young women seeking abortion care.

Setting

Gynaecological outpatient clinics at the Department of Gynaecology, Foshan Women and Children Hospital Affiliated to Guangdong Medical University, Foshan, Guangdong, China, between 2013 and 2023.

Participants

A total of 7361 young women aged 12–25 years seeking abortion services.

Measures

Data on abortion history, sociodemographic factors, contraceptive use and postabortion contraceptive choices were collected and analysed, with special emphasis on the incidence of repeat abortions and the factors associated with them.

Results

Of the 7361 participants, 34.2% reported at least one previous abortion, underscoring a notable public health concern. The mean age of the participants was 22.30 years (SD=2.13). Women with a history of abortion were significantly older than those without (22.57 vs 22.08 years, p

Conclusions

This study underscores the need for targeted interventions to address the multifaceted factors leading to repeat abortions among young women in China. The results offer valuable insights for improving reproductive health outcomes in this vulnerable population and highlight the importance of expanding access to contraceptive education and services in China.

☐ ☆ ✇ BMJ Open

Geographic barriers to gynaecological cancer care in Indonesia: a geospatial and infrastructure analysis

Por: Tjokroprawiro · B. A. · Sulistya · H. A. · Rahma · A. A. · Novitasari · K. · Ulhaq · R. A. · Yuliati · I. · Utami · T. W. · Anggraeni · T. D. — Marzo 23rd 2026 at 15:58
Objective

This study aimed to identify underserved regions and evaluate the population coverage based on travel time and distance to hospitals with gynaecologic oncologists in Indonesia.

Methods

The travel time and distance to hospitals with gynaecologic oncologists were evaluated using the Quantum Geographic Information System. Data from 139 gynaecologic oncologists and their affiliated hospitals were obtained from the Indonesian Society of Gynecologic Oncologists (November 2024) and cross-referenced with the Ministry of Health records. The female population density data were sourced from Facebook’s high-resolution settlement layer. Isochrones were generated to estimate travel times and distances using zonal statistics, which facilitated the calculation of population coverage.

Results

A total of 139 gynaecologic oncologists were identified nationwide, practising in 243 hospitals (7.6% of the 3202 hospitals in Indonesia), with a concentration in Java (60.4%). 11 of the 38 provinces lack sub-specialists. Population coverage varies sharply: the travel time to a hospital with gynaecologic oncologists is ≤2 hours for 79.1% of women in Java, compared with 4.9% in Papua; overall, 34.4% reside more than 100 km away from hospitals with gynaecologic oncologists. Hospitals with gynaecologic oncologists are predominantly urban class B general hospitals, and 83.1% participate in the National Health Insurance Schemes. Exploratory district-level correlations showed positive associations between the number of such hospitals and total female population (r=0.44, p

Conclusions

Gynaecological oncology services in Indonesia remain heavily concentrated in Java, leaving nearly one-fifth of women residing more than 100 km away. The travel time is greater than 2 hours for many. Targeted expansion of the gynaecologic oncologists workforce, diagnostic and treatment infrastructure, and sustainable financing mechanisms are required to close these gaps.

☐ ☆ ✇ BMJ Open

Latent trajectories of role adaptation in first-time pregnant women and their associations with pregnancy-specific psychological disorders: a longitudinal research protocol

Por: Ma · H. · Ge · L. · Wang · X. — Marzo 19th 2026 at 11:26
Introduction

Pregnancy constitutes a pivotal developmental transition for primigravidas. Although inadequate maternal role adaptation is a recognised predictor of antenatal distress, most existing studies have employed cross-sectional designs or concentrated primarily on the postpartum period. Little is known about the dynamic, longitudinal patterns of role adaptation during pregnancy or how these trajectories shape stage-specific psychological challenges. This study seeks to identify latent heterogeneous trajectories of maternal role adaptation among primigravidas and to evaluate their associations with stage-specific psychological outcomes, including pregnancy-related stress, body image disturbance and fear of childbirth.

Methods and analysis

This multicentre, prospective, longitudinal observational cohort study will enrol 240 primigravidas with a gestational age of 14 weeks or less from six tertiary hospitals in Shijiazhuang, China. Data will be collected at three clinically important time points, T0 (12–14 weeks), T1 (26–28 weeks) and T2 (35–37 weeks). Latent class growth analysis will be used to identify distinct trajectory subgroups of maternal role adaptation. The associations between these trajectory classes and stage-specific psychological outcomes, including pregnancy stress at T0, body image disturbance at T1 and fear of childbirth at T2, will be examined using the Bolck-Croon-Hagenaars method with demographic covariates controlled. Missing data will be managed using full information maximum likelihood estimation.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Hebei Provincial People’s Hospital (approval number 2025586). Written informed consent will be obtained from all participants. The study findings will be disseminated through publication in peer-reviewed journals, presentations at international academic conferences and summary reports shared with the participants.

Trial registration number

ChiCTR2500114060.

☐ ☆ ✇ BMJ Open

Towards personalised follow-up care in ovarian cancer using online remote PROMs monitoring: a study protocol of a feasibility trial

Por: Aarts · J. W. M. · Oudbier · S. J. · Van Muilekom · M. M. · Röling · P. · Tromp · J. · Smeulers · M. · van Lonkhuijzen · L. R. — Marzo 18th 2026 at 21:31
Introduction

Ovarian cancer patients often experience persistent symptoms such as fatigue and pain, impacting their quality of life. Current follow-up care, focused primarily on recurrence detection, may not adequately address these symptoms and can be burdensome. This study evaluates the feasibility of remote monitoring using patient-reported outcome measures (PROMs) and measurements of weight and abdominal circumference as an alternative to standard hospital visits. We aim to assess feasibility (ie, usability and satisfaction) of this approach and identify implementation barriers and facilitators.

Methods and analysis

This study is a single-centre longitudinal observational pilot that uses both qualitative and quantitative data to evaluate the feasibility of an innovative remote monitoring system for ovarian cancer follow-up care (Controle op Afstand, CopA). It is accessible to both healthcare professionals in the electronic health record and patients through the patient portal. Instead of 3-monthly in-hospital visits, patients are invited to complete regular surveys assessing PROMS about symptoms and quality of life and home measurements of weight and abdominal circumference. Feasibility will be assessed by (1) analysing patient and healthcare professional (HCP) experiences with CopA with the Measurement Instrument for Determinants of Innovations questionnaire for HCPs, and the ‘Experienced Usability and Satisfaction with Self-monitoring in the Home Setting’ questionnaire for patients, (2) investigating implementation barriers and facilitators using qualitative method and (3) performing a process evaluation of the intervention, assessing components such as reach, fidelity and compliance, time to response and number of (tele)consultations during the study period. Quantitative data will be analysed using descriptive statistics. Qualitative data will be analysed using thematic analysis.

Ethics and dissemination

This study was reviewed by the Ethics Committee of the Amsterdam University Medical Centre (METC 2022.0256) and exempted it from further review as this study was not subject to the Dutch Medical Research Involving Human Subject Act. Results will be disseminated via peer-reviewed open-access publications, scientific conferences and targeted communication to patient organisations, healthcare providers and the wider public.

☐ ☆ ✇ BMJ Open

Factors associated with return to meaningful activities following physiotherapy for pelvic girdle pain during pregnancy: 3-year follow-up of a randomised controlled trial

Por: Svahn Ekdahl · A. · Fagevik Olsen · M. · Gutke · A. — Marzo 18th 2026 at 21:31
Objectives

To investigate whether women who experienced pelvic girdle pain (PGP) during pregnancy were able to engage in meaningful activities at 4 months and 3 years post partum, and to identify factors associated with long-term functional outcomes.

Design

Long-term follow-up of a randomised controlled trial comparing acupuncture and transcutaneous electrical nerve stimulation for pregnancy-related PGP.

Setting

Physiotherapy outpatient clinics in Sweden.

Participants

In total, 113 pregnant women with clinically verified PGP were randomised in the original trial; 86 participated in the initial study phase, 77 attended the 4-month follow-up and 57 completed the 3-year follow-up questionnaire.

Primary and secondary outcome measures

The primary outcome was functioning, assessed using the Patient-Specific Functional Scale (PSFS). Secondary outcomes included self-reported PGP, overall functioning and the prognostic value of pelvic pain provocation tests at 4 months post partum for persistent PGP at 3 years.

Results

3 years post partum, the mean PSFS score was 8.64, and 45.6% of the participants scored 10, indicating full return to baseline activities. In repeated linear regression analyses, estimated PSFS scores were approximately 3 points lower at baseline and post-treatment compared with the 3-year follow-up (both p

Conclusions

Most women with pregnancy-related PGP regained functioning by 4 months post partum, and this recovery was sustained at 3 years. The number of positive pelvic provocation tests at 4 months post partum predicted persistent pain at 3 years, suggesting potential prognostic value for identifying women at risk of long-term PGP and informing postpartum follow-up strategies.

Trial registration number

In ‘FoU i Sverige’ (R&D in Sweden) No. 12726. https://www.researchweb.org/is/sverige/project/127261.

☐ ☆ ✇ BMJ Open

Association between exposure to non-steroidal anti-inflammatory drugs in pregnancy and miscarriage risk: a French nationwide retrospective cohort study

Por: Duong · C.-H. · Quentin · E. · Demailly · R. · Quantin · C. · Escolano · S. · Botton · J. · Tubert-Bitter · P. · Ahmed · I. — Marzo 18th 2026 at 21:31
Objective

To evaluate the association between non-steroidal anti-inflammatory drugs (NSAIDs) and miscarriage, which remains elusive in the actual literature, using modelling approaches to mitigate time-related bias.

Design

Nationwide, population-based retrospective cohort study.

Setting

The study used data from the French National Mother-Child Register (EPI-MERES), developed from the French National Health Data System containing the health information (hospital admissions, drug dispensing, comorbidities, etc.) of about 99% French population.

Participants

4 857 907 pregnancies ended in a live birth, a stillbirth or a miscarriage from 2013 to 2019.

Interventions

Exposure to NSAIDs from 2 weeks before conception to the 20th week of pregnancy.

Main outcome measures

Miscarriage (ie, spontaneous abortion before the 20th week of pregnancy) from the sixth week of pregnancy. The Cox regression with a time-dependent exposure that incorporated a 3-day lag was used to estimate HRs and their 95% CIs adjusted for maternal characteristics. The 3-day lag period allows for addressing protopathic bias.

Results

In total, there were 163 666 (3,37%) miscarriage cases, and 349 294 (7.19%) pregnancies were exposed to NSAIDs. Unexposed pregnancies were used as the reference category in all analyses. In the main analysis, exposure to NSAIDs increased the risk of miscarriage (HR, 1.83; 95% CI 1.81 to 1.86). The effect of individual drugs was heterogeneous, with 7 of the 19 drugs evaluated shown to increase the risk (flurbiprofen had the highest risk (HR, 3.28; 95% CI 3.15 to 3.41) and naproxen the lowest (HR, 1.09; 95% CI 1.01 to 1.18)). In the sensitivity analyses, increasing the lag time decreased the estimated HR (from HR, 2.25; 95% CI 2.21 to 2.28 with no lag to HR, 1.56; 95% CI 1.54 to 1.59 with a 7-day lag). Overall, the risk of miscarriage remained statistically significant in all the analyses.

Conclusions

Our study found that early exposure to NSAIDs could increase the risk of miscarriage. This finding contributes to the body of evidence on their safety profile and may help inform future recommendations for their use in pregnant women.

☐ ☆ ✇ BMJ Open

Cost-effectiveness of levonorgestrel intrauterine system versus hysteroscopic niche resection for caesarean scar-related spotting in China: an economic evaluation alongside a randomised controlled trial

Por: Zhu · C. · Wang · Y. · Yan · L. · Zhao · X. · Xia · W. · He · C. · Xu · H. · Zhang · J. · Mol · B. W. · Huirne · J. · Zhu · Q. — Marzo 13th 2026 at 12:35
Objective

To evaluate the cost-effectiveness of the levonorgestrel intrauterine system (LNG-IUS) compared with hysteroscopic niche resection (HNR) for women with niche-related postmenstrual spotting.

Design

Economic evaluation from a healthcare perspective, conducted alongside a randomised controlled trial with 12 months of follow-up.

Setting

A single-centre study at a university hospital in Shanghai was carried out between October 2019 and January 2021.

Participants

A total of 208 women aged 18–48 years with niche-related spotting who were suitable for a HNR, defined as a residual myometrium of at least 2.2 mm confirmed by MRI.

Intervention

Participants were randomly assigned to LNG-IUS insertion (n=104) or HNR (n=104).

Main outcome measures

The primary outcome was reduction in postmenstrual spotting at 6 months, defined as ≥50% decrease in spotting days compared with baseline. Cost-effectiveness was expressed as incremental cost-effectiveness ratios (ICERs), calculated by dividing cost differences in effective rate and spotting days.

Statistical analyses

Mean costs (diagnostic, examination, surgical) were compared between groups using Student’s t-test, standardised to 2019 price levels. Uncertainty around cost-effectiveness was assessed with non-parametric bootstrapping and cost-effectiveness acceptability curves.

Results

At 6 months, 78.4% (80/102) of women in the LNG-IUS group and 73.1% (76/104) in the HNR group reported improvement in spotting symptoms (RR 1.07, 95% CI 0.92 to 1.25). Spotting reduction was greater with LNG-IUS (0.0 days, IQR 0.0 to 2.8) compared with HNR (2.0 days, IQR 0.8 to 4.3; p

Conclusions

LNG-IUS is highly cost-effective compared with HNR for the treatment of niche-related postmenstrual spotting at 6 months. These findings support LNG-IUS as first-line therapy for niche-related spotting in women with a residual myometrium ≥2.2 mm.

Trial registration number

ChiCTR1900025677.

☐ ☆ ✇ BMJ Open

Barriers to integrating evidence-based practices into intrapartum care during vaginal births: a descriptive qualitative study in Sri Lanka

Por: Weerasingha · T. K. · Ratnayake · C. · Rathnayake · A. · Tennakoon · S. U. B. — Marzo 3rd 2026 at 13:40
Objectives

This study intended to investigate barriers to implementing evidence-based intrapartum care during vaginal births, from maternity care providers’ point of view.

Design

A descriptive qualitative study was conducted using in-depth interviews, with data analysed through thematic analysis.

Setting

The labour room of a major tertiary care hospital in Central Sri Lanka.

Participants

Purposively selected 17 maternity care providers including doctors, nurse managers, nurse-midwives and midwives.

Results

Three major themes and twelve sub-themes were generated: (1) barriers related to care providers (lack of human resources, negative attitudes of care providers, poor relationship among care providers, poor relationship between women and care providers, lack of knowledge on evidence-based practice in childbirth care); (2) barriers related to organisational environment (gaps in management, heavy workload, inadequate physical resources, insufficient in-service training and lack of availability/use of updated guidelines) and (3) barriers related to women’s birth preparedness (women’s limited knowledge on childbirth and intrapartum practices and women’s limited engagement during labour and childbirth). Many maternity care providers perceived that prevailing challenges to implement evidence-based childbirth care were one of the major reasons that impacted the quality of current childbirth care in the labour room.

Conclusions

The findings showed that an integrative approach may be essential to address the diverse barriers to the implementation of evidence-based intrapartum care. It is necessary to engage healthcare administrators, healthcare professionals and care recipients to enhance the quality of current childbirth care in the setting through the successful implementation of evidence-based care.

☐ ☆ ✇ BMJ Open

Protocol for a prospective cohort study for the assessment of sarcopenia in gestational diabetes: the SiGnal-D study

Por: Dardano · A. · Daniele · G. · Göbl · C. S. · Tura · A. — Marzo 2nd 2026 at 13:30
Introduction

Sarcopenia is characterised by loss of muscle mass and strength. Although ageing is the most likely risk factor of sarcopenia, sarcopenia is prevalent even in non-elderly people. Type 2 diabetes (T2D) is a risk factor for sarcopenia, as T2D shares with sarcopenia several aetiological factors. Meanwhile, gestational diabetes mellitus (GDM) is characterised by metabolic alterations that resemble those observed in T2D, including increased insulin resistance (present even in physiologic pregnancies). Hence, GDM presents two major risk factors for sarcopenia, that is, dysglycaemia and insulin resistance. Moreover, the number of pregnancies at age >40 years is increasing, which is in an age range in which sarcopenia prevalence is already not negligible. However, data on the prevalence of sarcopenia prevalence in GDM and its effect on pregnancy outcomes are limited. Thus, this study aims to evaluate the prevalence of sarcopenia in women with GDM (and in pregnant women without GDM), identify risk factors and determine its effect on delivery and maternal and fetal outcomes.

Methods and analysis

For this study, 100 each of women with and without GDM will be recruited. Women will undergo an oral glucose tolerance test within weeks 24–28 for possible GDM diagnosis (in weeks 16–18 for high-risk women). Muscle/physical performance tests will be conducted at weeks 28–32 for possible diagnosis of sarcopenia/presarcopenia. Cognitive function will also be assessed. For all women, information regarding pregnancy progression, along with any complications, will be collected. Collected data will be analysed according to the main objectives of the study: (i) determine the prevalence of sarcopenia/presarcopenia in pregnancy with and without GDM, (ii) identify factors associated with sarcopenia risk, (iii) determine the effect of sarcopenia/presarcopenia on pregnancy outcomes, (iv) explore the relationship between sarcopenia and cognitive function. Therefore, this study will provide information on sarcopenia/presarcopenia prevalence in GDM and, possibly, in pregnancy not complicated by dysglycaemia. Furthermore, the study will provide knowledge on the main factors associated with sarcopenia/presarcopenia in GDM/pregnancy. The identification of such factors will be relevant for an initial guidance for treatments that may prevent sarcopenia in GDM/pregnant women. This will become of even greater interest if sarcopenia/presarcopenia influences pregnancy outcomes, especially in GDM women.

Ethics and dissemination

The study protocol has been approved by the Comitato Etico Regione Toscana - Area Vasta Nord Ovest (CEAVNO) on 25 July 2024 and by the Local Ethics Committee of the Medical University of Vienna on 17 June 2024. Participants’ enrolment began in May 2025. The results of the study will be presented at national and international conferences and in peer-reviewed journals.

Trial registration number

ClinicalTrials.gov Identifier: NCT06876090; Registration Date: 2025-03-14

☐ ☆ ✇ BMJ Open

Disparities in adverse event perception between patients and healthcare providers in gynaecologic anticancer therapy: results from an observational web-based study in Japan

Por: Hashimoto · H. · Soejima · A. · Nishimura · Y. · Ike · A. · Sugawara · M. · Shimada · M. · Abe · M. — Febrero 26th 2026 at 13:47
Objective

To explore patients’ perceptions of managing adverse events (AEs) from anticancer drugs for gynaecological cancer, focusing on AEs they want to avoid, views on dose adjustments and communication with healthcare professionals.

Design

Observational study using a web-based questionnaire.

Participants

Women in Japan who had received chemotherapy for endometrial or ovarian/fallopian tube cancer were enrolled. Healthcare professionals, including obstetrics and gynaecology physicians, nurses and pharmacists, who administered chemotherapy to these patients, were also enrolled.

Outcome measures

AEs that patients wished to avoid or found distressing; varied perceptions of AEs before and after treatment; discrepancies in the communication of AEs between patients and healthcare professionals; administration time and intervals between hospital visits patients found distressing; patient awareness of dose adjustment (reduction, interruption or discontinuation) to suppress AEs.

Results

Participants comprised 153 physicians, 166 nurses, 154 pharmacists and 154 patients. Nausea/vomiting (28.6%), alopecia (18.2%) and peripheral neuropathy (9.1%) were the most distressing AEs overall. Physicians rated nausea/vomiting lower (15.4%) and alopecia higher (38.2%) than patients, while pharmacists emphasised peripheral neuropathy (25.7%). Many patients found AEs, including peripheral neuropathy (53/99), fatigue (52/105) and alopecia (46/120), to be more severe than expected. Communication patterns revealed that 49.4% of patients reported all symptoms, even uncertain ones, but younger patients tended to communicate fewer symptoms. Physicians (54.2%), nurses (92.2%) and pharmacists (85.7%) preferred full disclosure of symptoms. While 28.6% of patients wished to avoid dose reductions because of fears of disease progression, 18.2% preferred dose reduction or discontinuation when AEs became intolerable. Drug administration times and visit intervals influenced patient distress. Treatment administration of over 3 hours (19.5%) and visits occurring more frequently than once every 3 weeks (27.3%) were the most distressing.

Conclusions

This study highlights discrepancies in AE perceptions and communication between patients and healthcare professionals, emphasising the need for tailored communication strategies and shared decision-making to improve cancer treatment experiences and outcomes.

Trial registration number

jRCT1040220088, Japan Registry of Clinical Trials (jRCT).

☐ ☆ ✇ BMJ Open

Contribution of contrast-enhanced ultrasound for diagnosis of adnexal torsion (COVARIAN): protocol for a randomised controlled trial

Por: Fijean · A.-L. · Manhertz · D. · Massicot · L. · Lecointre · L. · Mottet · N. · Raimond · E. · Simon · E. · Gabriele · V. · Morel · O. · Beaumont · M. · Hossu · G. · Bertholdt · C. — Febrero 26th 2026 at 04:41
Introduction

Adnexal torsion is a gynaecological emergency in which prompt diagnosis and management are critical to preserving ovarian function. However, the clinical presentation is often non-specific, and diagnosis primarily relies on pelvic ultrasound, a modality with limited sensitivity that can lead to misdiagnosis and unnecessary surgery. Contrast-enhanced ultrasound (CEUS) has emerged as a promising imaging technique that may enhance diagnostic accuracy by better characterising adnexal vascularisation.

The aim of this study is to assess whether the addition of CEUS to standard diagnostic procedures can reduce the rate of unnecessary emergency surgeries. Specifically, we compare two diagnostic strategies in cases of high clinical suspicion of adnexal torsion: the current standard approach versus an experimental strategy incorporating CEUS. The primary outcome is the rate of inappropriate surgical interventions, defined as emergency surgery performed within 6 hours without intraoperative confirmation of torsion.

Methods and analysis

This is a prospective, open-label, multicentre, randomised (1:1), controlled, superiority trial. A total of 256 women presenting with a high clinical suspicion of adnexal torsion will be enrolled over a period of 36 months. Participants will be randomly assigned to either the standard diagnostic strategy or an experimental strategy that includes CEUS. The primary endpoint is the proportion of emergency surgical procedures (performed within 6 hours of hospital admission) in which adnexal torsion is not confirmed.

Ethics and dissemination

The study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) on 28 October 2024. The results of this study will be published in peer-reviewed journals and presented at relevant national and international conferences. The ethical approval number from the CPP is 6115.

Registration number

NCT06677554; 2024-511720-13-00.

☐ ☆ ✇ BMJ Open

Predicting outcomes in selective fetal growth restriction of monoChOrioNic Twins: an inteRnAtional observational cohort STudy protocol (CONTRAST study)

Por: Noll · A. · Javinani · A. · Slaghekke · F. · Haak · M. C. · van Klink · J. · Van der Meeren · L. · Lopriore · E. · Russo · F. · Aertsen · M. · Shamshirsaz · A. · Shinar · S. · Bennasar · M. · Tiblad · E. · Herling · L. · Lewi · L. · Verweij · E. · CONTRAST Study Group · Keizer · Steggerd — Febrero 24th 2026 at 16:52
Introduction

Selective fetal growth restriction (sFGR) is a major cause of perinatal morbidity and mortality in monochorionic diamniotic (MCDA) twin pregnancies. Current management relies on umbilical artery Doppler patterns in the smaller twin. These patterns are, however, inconsistent and do not represent a reliable severity scale, complicating clinical decision-making and parental counselling. This study aims to improve risk stratification by identifying predictors of adverse outcomes, while also evaluating the pathophysiology and multi-organ impact of sFGR in early childhood.

Methods and analysis

This is a prospective, international, multicentre cohort study conducted in six tertiary fetal medicine centres with expertise in complicated twin pregnancies. Recruitment began in March 2023 and will continue until December 2026, targeting 274 MCDA twin pairs with complete follow-up to develop a prediction model for adverse perinatal outcomes in sFGR at the time of diagnosis. Standardised data collection includes serial ultrasound examinations, advanced fetal imaging (cardiac, cerebral and 3D volumetric), fetal brain MRI and detailed placental phenotyping. Maternal and parental well-being are assessed during pregnancy and after birth. Neurodevelopmental outcome is evaluated up to 2 years after birth using validated tools. The statistical analysis plan includes predictive modelling with internal validation.

Ethics and dissemination

The study has been approved by the ethical review boards of all participating centres. Findings will be disseminated through peer-reviewed publications, international conferences and engagement with clinical guideline committees.

Trial registration number

NCT05952583.

☐ ☆ ✇ BMJ Open

Association between smoking behaviours during early pregnancy and the severity of gestational diabetes mellitus: a secondary analysis of prospectively collected cohort data in Korea

Por: Lim · J. H. · Joo · E. H. · Han · H.-J. · Ko · J. S. · Chung · B. · Kim · J. W. · Kim · J. Y. · Choi · Y. J. · Yang · S. J. · Han · Y. J. · Kwak · D. W. · Lee · H. J. · Ryu · H. M. — Febrero 24th 2026 at 16:52
Objective

This study aimed to investigate the association between smoking behaviours during early pregnancy and the risk and severity of gestational diabetes mellitus (GDM), with a particular focus on smoking status, smoking intensity and secondhand smoke exposure.

Design

Secondary analysis of prospectively collected cohort data.

Setting

Multi-centre study conducted in South Korea (Korean Pregnancy Outcome Study) between March 2013 and January 2017.

Participants

From 4537 pregnant women initially enrolled, 3457 singleton pregnancies were included after excluding cases with transfer, loss to follow-up, twin pregnancies, miscarriages and pre-existing diabetes mellitus. All participants were women of Korean ethnicity.

Secondary outcome measures

Primary outcome was GDM and its subtypes (A1GDM: diet-controlled; A2GDM: insulin-requiring). Secondary outcomes were associations with active smoking (before pregnancy and during early pregnancy), smoking intensity dose–response relationships (pack-years) and secondhand smoke exposure among never-smokers.

Results

Among 3457 participants, 231 women (6.7%) were diagnosed with GDM (198 A1GDM, 33 A2GDM). Active smoking before pregnancy (adjusted OR (aOR) 3.98, 95% CI 1.58 to 9.30) and during early pregnancy (aOR 9.90, 95% CI 2.97 to 29.45) were significantly associated with A2GDM, while no significant association was observed with A1GDM. A clear dose-response relationship was observed, with smoking intensity >4 pack-years markedly increasing A2GDM risk (aOR 20.68, 95% CI 6.75 to 59.39). Detailed pack-year analysis showed 4–6 pack-years (aOR 20.57, 95% CI 5.80 to 65.46) and >6 pack-years (aOR 25.98, 95% CI 3.21 to 146.45). Among never-smokers, secondhand smoke exposure showed a borderline association with overall GDM risk (aOR 1.33, 95% CI 0.98 to 1.81).

Conclusions

Maternal active smoking before and during early pregnancy, as well as higher smoking intensity, was associated with an increased risk of pharmacologically treated GDM (A2GDM). Although secondhand smoke exposure did not reach statistical significance, the trend suggested a potential association with GDM risk among never-smokers. These findings provide important evidence for public health strategies for prenatal care, as smoking cessation and environmental smoke avoidance during prenatal and early antenatal care in women reduce the risk of gestational diabetes.

☐ ☆ ✇ BMJ Open

Optimising internet-based cognitive-behavioural therapy programme to prevent perinatal depression: a unified protocol for two harmonised randomised controlled trials

Por: Toyomoto · R. · Furukawa · T. A. · Noma · H. · Tajika · A. · Watanabe · M. · Honda · Y. · Banno · C. · Ogasawara · S. · Kitaori · T. · Sugiura-Ogasawara · M. · Goto · S. — Febrero 18th 2026 at 14:51
Introduction

Perinatal depression poses substantial risks to both mothers and their offspring. Given its chronic and recurrent nature, developing effective prevention strategies is crucial. Internet-based cognitive–behavioural therapy (iCBT) has shown promise. However, the efficacy of specific CBT skills and the influence of individual differences remain unclear.

Methods and analysis

This protocol describes two harmonised multicentre, open-label, six-arm randomised controlled trials. Across both trials, a total of 2400 pregnant women between 10 and 20 weeks of gestation will be enrolled. After completing psychoeducation (PE), participants will be randomised to either the control condition (PE only) or one of five CBT programmes: behavioural activation (BA), assertion training, BA+cognitive restructuring, BA + problem solving or BA + behaviour therapy for insomnia. The objectives of the study are: (1) to ascertain that the iCBT approach is effective in perinatal depression, (2) to identify active CBT skills for perinatal women and (3) to examine interactions between these CBT skills and individuals’ baseline characteristics to find personalised and optimised therapy for individual women. The primary outcome is the point prevalence of depression at 1 month postpartum, defined as scoring of 9 or higher on the Edinburgh Postnatal Depression Scale.

Ethics and dissemination

The study has been approved by the Kyoto University Graduate School of Medicine Ethics Committee (C1710) and Nagoya City University Certified Review Board (2024A007). Anonymised study results will be presented at conferences and published by the investigators in peer-reviewed journals.

Trial registration number

jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).

☐ ☆ ✇ BMJ Open

Dietary practices among antenatal women in Sri Lanka: prevalence and associated factors

Por: Jayasooriya · L. H. D. D. · Uthpala · U. H. T. · Rajamuni · R. D. S. G. · Afridi · A. M. M. · Nawanjana · N. M. I. · Fernando · H. S. P. · De Silva · D. K. M. · Herath · H. M. C. M. — Febrero 16th 2026 at 14:29
Objective

To assess the prevalence and associated factors of dietary practices among antenatal women in Colombo district, Sri Lanka.

Design

This descriptive cross-sectional study examined dietary practices among antenatal mothers in four Medical Officer of Health areas in Colombo, Sri Lanka. A total of 422 participants were selected using stratified random sampling. Data were collected via a validated Food Frequency Questionnaire and analysed using SPSS V.26. Dietary diversity, food variety and animal-source food consumption were assessed. Poisson regression identified predictors of dietary practices, adjusting for socio-economic and pregnancy-related factors. The statistical significance was set at p

Results

Of the 380 antenatal mothers (mean age: 30.72±3.96 years), most were married (98.2%) with 73.7% living in urban areas. Regarding dietary practices, 64.7% had high dietary diversity, while 35.3% had low diversity. Of the sample, 52.1% had a high food variety score and 64.7% had a high animal-source food score. More than half (64.7%) had appropriate dietary practices. Fruits, vitamin A-rich vegetables and rice were the most consumed foods. Key factors influencing dietary practices included age, religion, education, employment and geographical location.

Conclusions

This study highlights the prevalence and factors influencing dietary practices among antenatal mothers. Although the predominant mothers had fair dietary diversities, a considerable number were found to have poor dietary practices. Better dietary practices were associated with major educational attainment, formal employment status and selected residential areas, while younger age, low educational qualification and housewife status were associated with poorer nutrition. The findings indicate that there is an urgent need for interventions related to nutrition for specific vulnerable groups so that they can improve their maternal nutrition and produce better pregnancy outcomes through education and support programmes.

☐ ☆ ✇ BMJ Open

Effectiveness of online supportive counselling on quality of life in women with high-risk human papillomavirus in Iran: study protocol for a randomised controlled trial

Por: Mikaeil · A. · Nasiri-Amiri · F. · Shafizadeh · F. · Behmanesh · F. · Hamzehpour · R. · Bijani · A. · Delavar · M. A. · Afshar · Z. M. — Febrero 15th 2026 at 19:02
Introduction

Human papillomavirus (HPV) is one of the most common sexually transmitted diseases and affects the quality of life (QoL) of individuals, necessitating interventions beyond physical treatments. The aim of this study is to determine the effectiveness of individual supportive counselling on the QoL in women with high-risk HPV.

Methods and analysis

This randomised clinical trial will include 80 women with HPV who will be selected from 2025 to 2026 in Babol, Iran. Following selection based on inclusion criteria, samples will be randomly allocated to intervention and control groups. Then, they will complete demographic–social questionnaires, QoL in HPV patients and general health questionnaires. Individuals in the intervention group will receive 4 weekly online supportive counselling sessions in addition to routine care. The control group will receive routine care. Both groups will complete the questionnaires again at 6 weeks and 4 months postbaseline. Data will be analysed using SPSS V.26 software and statistical tests including ², t-test and repeated measures analysis of variance, and regression models if necessary. A significance level of 5% will be used for the tests.

Ethics and dissemination

This study was approved by the Ethics Committee of Babol University of Medical Sciences (IR.MUBABOL.HRI.REC.1404.082). The trial will adhere to the ethical principles of the Declaration of Helsinki. Findings will be disseminated through publication in peer-reviewed journals and presentation at scientific conferences.

Trial registration number

IRCT20180218038783N11, 14 September 2025.

☐ ☆ ✇ BMJ Open

Longitudinal study of childbirth readiness and its related factors and consequences among low-risk pregnant women attending health centres in Tabriz, Iran

Por: Alizadeh-Dibazari · Z. · Abbasalizadeh · F. · Mohammad-Alizadeh-Charandabi · S. · Mirghafourvand · M. — Febrero 10th 2026 at 14:17
Objective

Childbirth readiness can reflect women’s childbirth readiness in terms of knowledge, psychological aspects and planning. The purpose of this study was to evaluate childbirth readiness, its related factors and consequences in Iranian pregnant women.

Design

This longitudinal study was the first stage (quantitative stage) of a sequential explanatory mixed-method study. It followed women during late pregnancy (from 37 weeks of gestation) and the postpartum period (4–6 weeks after childbirth) from March to September 2023.

Setting

Health centres of Tabriz, Iran.

Participants

This study involved 360 pregnant women with a gestational age of 37 weeks and above, selected via cluster sampling. Participants were excluded for high-risk pregnancies, unfavourable incidents in the last 3 months, mental-psychological diseases or a prior caesarean section.

Outcome measures

Childbirth readiness and its related factors were assessed using several instruments completed from the 37th week of pregnancy onward, including the Childbirth Readiness Scale, a sociodemographic questionnaire, the Pregnancy Experience Scale and the Wijma Delivery Expectancy/Experience Questionnaire Version A. The consequences of childbirth readiness were then evaluated 4–6 weeks post partum using the Childbirth Experience Questionnaire, the Edinburgh Postnatal Depression Scale and the Postpartum-Specific Anxiety Scale.

Results

The mean (SD) childbirth readiness score was 67.83 (9.41) out of 90. In the adjusted general linear model (GLM), several factors were significantly associated with lower readiness. These included a higher fear of childbirth score (β –0.12, 95% CI –0.16 to –0.08, p

Conclusions

Key factors associated with readiness included fear of childbirth, obstetric history (gravidity, parity, history of abortion and participation in childbirth readiness classes), maternal education, home ownership, husband’s occupation—though several associations showed small effect sizes. After adjustment, readiness did not independently predict childbirth experience or postpartum mental health. The low participation rate in readiness courses highlights a major service gap. Integrating readiness assessment into prenatal care and expanding access to targeted education are recommended to improve outcomes such as birth satisfaction and caesarean rates.

☐ ☆ ✇ BMJ Open

Azithromycin use in labour to prevent sepsis among pregnant women undergoing vaginal delivery in Nigeria (AZIN-V): a study protocol for a hybrid type 2 effectiveness-implementation trial

Por: Afolabi · B. B. · Makwe · C. C. · Oluwole · E. O. · Obi-Jeff · C. · Mitchell · E. J. · Banke-Thomas · A. · Adeyemo · T. A. · Abioye · A. I. · Eboreime · E. A. · Saidu · A. D. · Okoro · U. A. · Akintan · P. · Osuagwu · C. S. · Chieme · C. F. · Lawanson · T. · Hossain · A. · Walker · K. — Febrero 6th 2026 at 14:29
Introduction

Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%–60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.

Methods and analysis

This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria’s unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care—the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).

For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.

Ethics and dissemination

This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Committee: ERC/PAN/2025/03/0581; University of Benin Teaching Hospital Health Research Ethics Committee: ADM/E22/A/VOL. VII/483117141; Aminu Kano Teaching Hospital Research Ethics Committee: AKTH/MAC/SUB/12 A/P-3/VI/2509 and Irrua Specialist Teaching Hospital Research Ethics Committee: ISTH/HREC/20241507/605), the Ministries of Health of the six states and the National Agency for Food and Drug Administration and Control. Written informed consent will be obtained from all eligible study participants before enrolment. Results will be shared with communities and policy stakeholders and through peer-reviewed journals and will be presented at conferences.

Trial registration number

ISRCTN16415327.

☐ ☆ ✇ BMJ Open

Maternity care bundle for UK women with multiple long-term health conditions: coproduction workshops

Por: Hanley · S. · McCann · S. · Singh · M. · Vowles · Z. · Lee · S. I. · Plachcinski · R. · Nirantharakumar · K. · Black · M. · Locock · L. · Taylor · B. — Febrero 6th 2026 at 14:29
Objective

The objective of this study is to co-produce a care bundle for women with multiple long-term health conditions (MLTC) that could be pilot tested and implemented in UK maternity services.

Design

Online co-production workshops each attended by 20–30 key interest holders.

Setting

United Kingdom, October 2023-February 2024.

Population

Women with experience of pregnancy with MLTC, healthcare professionals and other interest holders involved in commissioning, planning and delivering care for pregnant women with MLTC.

Methods

This study followed a three-step process: (1) a consolidated list of key components of care for pregnant women with MLTC was created through secondary analysis of prior collected qualitative data; (2) the list of care components was explored during four co-production workshops; and (3) findings from (1) and (2) were synthesised to develop a maternity care bundle of 4–5 key care components for pregnant women with MLTC.

Main outcome measures

A maternity care bundle of five key care components for pregnant women with MLTC.

Results

A list of 25 care components was refined to develop a proposed care bundle of five components. These were provisions of early and reliable medication advice and decision support; creation of a ‘goals of care summary’ accessible to women and the care team; provision of continuity of midwifery care throughout pregnancy and postnatal care; provision of a named care coordinator; and a formal postnatal handover of care from the multidisciplinary care team to the General Practitioner (GP) and secondary care team involving the woman.

Conclusions

This study coproduced an evidence-based care bundle for pregnant women with MLTC to enhance communication and ensure individualised care and support. Further collaborative work with women and professionals is required to refine, implement and evaluate its impact on outcomes.

☐ ☆ ✇ BMJ Open

Association between repeat caesarean section and postpartum depression: an observational cohort study in Shanghai, China

Por: Lin · R. · Shuai · W. · Yu · Y. · Ma · R. · Zhou · X. · Luo · W. · Shen · F. · Xu · Z. — Febrero 2nd 2026 at 16:02
Objectives

Although caesarean section (CS) has been reported as one of the potential risk factors for postpartum depression (PPD), there is uncertainty about the association between repeat CS and the risk of developing PPD. We sought to explore whether repeat CS will further increase the risk of PPD compared with primary CS.

Design

Observational cohort study.

Setting

A tertiary maternity hospital in Shanghai, China.

Participants

571 women, aged 20 years and older, full-term parturients with singleton scheduled for elective primary or repeat CS were enrolled between December 2020 and September 2021.

Primary and secondary outcome measures

An increased risk of PPD was defined as the total scores of the Edinburgh Postnatal Depression Scale ≥11. The primary outcome was the risk of PPD at 6 weeks postpartum. Secondary outcomes included the risk of postpartum depressive symptoms at 48 hours after CS, pain situation at 48 hours after CS and 6 weeks postpartum.

Results

Among the 571 women included in the final analyses, PPD at 6 weeks postpartum occurred in 41 women (24.0%) in the repeat CS group (n=171) versus 93 (23.3%) in the primary CS group (n=400). After adjusting for the confounders, repeat CS was not associated with higher odds of PPD at 6 weeks postpartum (adjusted relative risk (aRR), 1.04 (95% CIs 0.73 to 1.45); adjusted risk difference (aRD), 0.03 (95% CI –0.32 to 0.37), p=0.84). Compared with primary CS, women with repeat CS were more likely to report significant uterine contraction pain (NRS ≥4) at 48 hours after CS (aRR, 1.51 (95% CI 1.23 to 2.03); aRD, 0.41 (95% CI 0.12 to 0.71), p

Conclusions

Repeat CS was not associated with the increased risk of PPD at 6 weeks postpartum in comparison to primary CS. But women undergoing elective repeat CS were more likely to suffer significant uterine contraction pain in early postoperative stage.

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