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Rebozo and maternal postures to prevent persistent occiput posterior position of the fetal head: protocol for a randomised clinical trial 'the ReMaP-POPP RCT

Por: Ornaghi · S. · Fumagalli · S. · Antolini · L. · Panzeri · M. · Spandrio · R. · Ferrini · S. · Nespoli · A. · Maini · M. · Locatelli · A.
Introduction

Occiput posterior position is the most common fetal malposition, complicating up to 35% of initial labours, and its persistence can lead to increased risks of adverse maternal and perinatal outcomes. The role of maternal postures, such as lateral recumbent and hands-and-knees, in promoting the anterior rotation of the fetal head has been investigated in several randomised trials in the last two decades, with mostly negative results. However, both methodological and study design limitations may have contributed to such findings. Recently, the use of forward-leaning inversion and side-lying release procedures and of the Rebozo technique has been implemented into clinical practice as a non-invasive alternative to promote the anterior rotation of the fetal head. Yet, neither intervention has been rigorously assessed in a controlled study. Our aim is to conduct a randomised controlled trial to assess whether a combination of forward-leaning inversion and side-lying release procedures and the Rebozo technique in a pre-specified sequence during the first stage of labour of women with a posterior fetus would favour its anterior rotation.

Methods and analyses

The ReMaP-POPP (Rebozo and maternal procedures to prevent persistent occiput posterior position of the fetal head) trial will be an open-label single-centre randomised controlled trial with two parallel groups. Women will be eligible if they are ≥18 years old, in labour (3 to 8 cm) and with a singleton term fetus (≥370/7 weeks) in an occiput posterior position confirmed by transabdominal sonography. Eligible women will be randomised into two groups: (1) intervention, a sequence of forward-leaning inversion and side-lying release procedures and Rebozo technique (duration 90–105 min); and (2) control, standard of care (maternal postures, including upright, lateral recumbent and hands-and-knees). Blinding will be guaranteed only for the physician assessing the fetal head position by sonography. Randomisation will be performed using randomly permuted blocks of varying sizes (4, 6 and 8), stratified by parity, in a 1:1 ratio. The primary outcome will be the probability of occiput posterior position of the fetal head 3 hours and 30 min after randomisation, diagnosed by sonography. Secondary outcomes will include the probability of occiput posterior position at full cervical dilation and at birth, maternal and neonatal health-related outcomes, as well as maternal pain intensity and ability to cope with pain and birth satisfaction level. We will also assess safety outcomes regarding challenges in adequate fetal heart rate monitoring during the time interval between randomisation and primary outcome assessment. Sample size estimation considered the possibility to decrease the probability of occiput posterior position from 35.8% (control, based on prior retrospective data at our Institution) to 22% with the proposed intervention. With a power of 0.90 and a two-sided value of 0.05, the estimated sample size will be n=462 (n=231/arm). Considering a potential attrition rate of 20%, n=578 women will be needed. Enrolment will require approximately 16 months. Primary and secondary outcomes will be analysed on an intention-to-treat basis. The effects of the intervention will be estimated by relative risks and their 95% CI.

Ethics and dissemination

The study has been approved by the Lombardy Ethics Committee n.3 (n. 5499, 20 December 2024). Written informed consent will be obtained from all participants. Women will be free to decline participation or to withdraw at any time. Findings will be presented at scientific meetings and published in peer-reviewed scientific journals in the field of midwifery and obstetrics. Also, they will be disseminated to the public through outreach activities involving families and healthcare specialists.

Trial registration number

The study has been registered in the Clinical Trials database (NCT06887634).

Addressing the needs and identifying supports for parents of chronically ill adolescents and young adults in their shared transition from paediatric to adult care: a scoping review protocol

Por: Maini · P. · Tersigni · C. · Micsinszki · S. K. · Cairns · S. · Murray · K. · Frost · K.
Introduction

The transition from paediatric to adult healthcare marks a pivotal period for chronically ill adolescents, as they transition from a highly supportive and family-oriented environment to an adult-oriented and a more individual-oriented healthcare system that places a greater emphasis on personal responsibility and independence. Parents, given their firsthand experience managing their child’s healthcare, play a central role in ensuring a smooth and successful transition, yet their perspectives on the barriers and facilitators of this complex process remain vastly underexplored. This scoping review aims to assess and provide comprehensive insights into parents’ perceptions of the successes and challenges during their adolescents’ transition from paediatric to adult healthcare.

Methods and analysis

This scoping review is led by patient partners and will be guided by the Peters et al and the Joanna Briggs Institute guidelines for scoping reviews. The preliminary search strategy will be developed and calibrated in Ovid MEDLINE and will be subsequently replicated in the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsychInfo, Embase, Web of Science and Sociological Abstracts from inception through 18 December 2024, including all types of studies. Grey literature sources recommended by patient partners and clinical and qualitative research experts will also be included. Two reviewers will independently perform the title and abstract review of all studies against the predefined inclusion and exclusion criteria, followed by the full-text review of included studies. The reference list of all included studies will also be screened to maximise the retrieval of relevant sources. Data will be extracted and analysed quantitatively and qualitatively, with the study procedural and reporting format following Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Ethics and dissemination

This scoping review, through the broad and systematic mapping of existing literature, aims to provide a foundation for developing targeted support systems, strategies and interventions to address the unique needs and barriers faced by parents and caregivers of chronically ill adolescents during this critical transition to adult care.

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