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Effectiveness of a web-based preventive postpartum depression programme in pregnancy, with/without telephone support: a randomised control trial

Por: Dessy · T. · Montreuil · T. C. · St-Andre · M. · Herba · C. M. · MacKinnon · A. L. · Clement · M. · Boucoiran · I. · Dinello-Goupil · C. · Beland · J. · Samson · V. · Tchouangue-Dinkou · G.-D. · Berard · A. · Morin · L. · Amirali · L. · Dennis · C.-L. · Masse · B. · Cote · S. M.
Objective

To evaluate the effectiveness of a web-based secondary prevention programme for postpartum depression, delivered with or without telephone support, compared with usual care.

Design

We first conducted a randomised controlled superiority trial to test whether the web-based Parents and Babies programme (Toi, Moi, Bébé; TMB) delivered with motivational telephone support (ie, coaching) was superior to the fully automated programme (ie, self-help). TMB incorporated classic and third-wave cognitive–behavioural therapy components and psychoeducation. Then, we tested whether TMB (both treatment modalities combined) was superior to usual care. The usual care comparison group was drawn from the CONCEPTION prospective pan-Canadian perinatal cohort (N=592).

Setting

A remote study based at Sainte-Justine Hospital Centre, Quebec, Canada.

Participants

Web-based intervention programme participants were women aged ≥14 years at 12–25 weeks’ gestation, with subclinical to moderate clinical Edinburgh Postnatal Depression Scale (EPDS) scores: 9–16. Exclusion criteria were psychosis and self-reported substance abuse. The usual care comparison group was pregnant women ≥18 years old. All participants were living in Canada at study inception.

Main outcome measures

The primary outcome was EPDS scores at 3 months post partum, accounting for baseline EPDS scores and depression events defined as EPDS ≥13 at 3 months post partum. The secondary outcomes were EPDS scores at 6 months post partum, depression events (EPDS≥13) at 6 months post partum, anxiety symptoms (Generalised Anxiety Disorder 7-item Scale, GAD-7) at 3 and 6 months post partum, accounting for baseline scores for the continuous outcomes; as well as the number of completed intervention modules and well-being scores (WHO 5-Item Well-being Index) at 3 months post partum.

Results

We randomised 510 participants to TMB self-help (n=255) or TMB with coaching (n=255); 211 and 214 participants, respectively, were included in the complete-case intention-to-treat analyses. At baseline, 91% lived with a partner, 71% were university graduates and 42% self-reported GAD-7≥10. Randomisation was successful. First, TMB with coaching was not superior to TMB self-help: at 3 months post partum, EPDS scores were TMB self-help (mean 8.0±4.3) vs TMB with coaching (mean 8.6±4.5); effect size was 0.01 (95% CI 0.00 to 0.03; p=0.16). Second, TMB (regardless of intervention arm) was superior to usual care: in adjusted regression models, EPDS scores were 6.2 units lower (per SD, 95% CI –8.2 to –4.3) in TMB (both treatment modalities combined) than in usual care; and proportions of depression events were 4.7 units lower (per SD on the logit scale, 95% CI –6.6 to –2.7) in TMB (combined) than in usual care. No other group differences were observed.

Conclusions

Our findings suggest that, in women with subclinical to moderate clinical antenatal depressive symptoms, receiving a web-based cognitive–behavioural therapy-based programme in addition to usual care can reduce depression postnatally.

Trial registration number

NCT05110456.

Safety of COVID-19 vaccines among pregnant individuals in Quebec, Canada: a population-based retrospective cohort study from the Canadian Immunization Research Network

Por: Kiely · M. · Diendere · E. · Dialahy · I. · Perrault-Sullivan · G. · Brousseau · N. · Wei · S. Q. · Talbot · D. · Boutin · A. · Quach · C. · Jorgensen · S. · Boucoiran · I.
Objective

To estimate the association between maternal COVID-19 vaccination during pregnancy and adverse neonatal and maternal outcomes.

Design

Population-based retrospective cohort study using a hospitalisation database linked with other health administrative databases.

Setting

Province of Quebec, Canada, from 1 May 2021 to 30 June 2023.

Participants

All singleton pregnancies resulting in a live birth or stillbirth at ≥20 weeks of gestation, excluding those with a conception date

Primary outcome measures

We used robust Poisson regression models to estimate adjusted risk ratios (aRRs) for chorioamnionitis, postpartum haemorrhage, caesarean delivery, preterm birth, very preterm birth, small for gestational age (SGA), maternal and neonatal admission to intensive care unit (ICU, NICU) and severe neonatal morbidity. We used a Cox regression model with a time-varying exposure variable to estimate adjusted HRs (aHRs) for stillbirth. Propensity score weighting was used to adjust for potential confounding.

Results

Among 140 073 singleton pregnancies resulting in live birth or stillbirth, 61 282 individuals (43.8%) received at least one dose of messenger RNA COVID-19 vaccine during pregnancy. Vaccination during pregnancy was not associated with an increased risk of chorioamnionitis (aRR 0.99, 95% CI 0.95 to 1.04), postpartum haemorrhage (aRR 1.03, 95% CI 0.99 to 1.06), very preterm birth (aRR 1.04, 95% CI 0.89 to 1.21) and stillbirth (aHR 1.14, 95% CI 0.94 to 1.39). Vaccination during pregnancy was significantly associated with a reduced risk of caesarean delivery (aRR 0.94, 95% CI 0.92 to 0.96), maternal ICU admission (aRR 0.80, 95% CI 0.65 to 0.98), SGA (aRR 0.94, 95% CI 0.91 to 0.98), NICU admission (aRR 0.91, 95% CI 0.85 to 0.96), preterm birth (aRR 0.94, 95% CI 0.90 to 0.99) and severe neonatal morbidity (aRR 0.91, 95% CI 0.85 to 0.98).

Conclusions

Our findings suggest that COVID-19 vaccination during pregnancy was not associated with an increased risk of adverse outcomes. Ongoing surveillance of the safety of maternal COVID-19 vaccination is essential as doses continue to be recommended for this group.

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