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Feasibility of Conducting a Trial Assessing Benefits and Risks of Planned Caesarean Section Versus Planned Vaginal Birth: A Cross-Sectional Study.

Abstract：

INTRODUCTION:Though interest is growing for trials comparing planned delivery mode (vaginal delivery [VD]; cesarean section [CS]) in low-risk nulliparous women, appropriate study design is unclear. Our objective was to assess feasibility of three designs (preference trial [PCT], randomized controlled trial [RCT], partially randomized patient preference trial [PRPPT]) for a trial comparing planned delivery mode in low-risk women. METHODS:A cross-sectional survey of low-risk, nulliparous pregnant women (N = 416) and healthcare providers (N = 168) providing prenatal care and/or labor/delivery services was conducted in Argentina (2 public, 2 private hospitals). Proportion of pregnant women and providers willing to participate in each design and reasons for not participating were determined. RESULTS:Few women (< 15%) or professionals (33.3%) would participate in an RCT, though more would participate in PCTs (88% women; 65.9% professionals) or PRPPTs (44.4% public, 63.4% private sector women; 44.0% professionals). However, most women would choose vaginal delivery in the PCT and PRPPT (> 85%). Believing randomization unacceptable (RCT, PRPPT) and desiring choice of delivery mode (RCT) were women's reasons for not participating. For providers, commonly cited reasons for not participating included unacceptability of performing CS without medical indication, difficulty obtaining informed consent, discomfort enrolling patients (all designs), and violating women's right to choose (RCT). CONCLUSIONS FOR PRACTICE:Important limitations were found for each trial design evaluated. The necessity of stronger evidence regarding delivery mode in low-risk women suggests consideration of additional designs, such as a rigorously designed cohort study or an RCT within an obstetric population with equivocal CS indications.

journal_name

Matern Child Health J

journal_title

Maternal and child health journal

authors

Amyx MM,Althabe F,Rivo J,Pingray V,Minckas N,Belizán M,Gibbons L,Murga GT,Fiorillo ÁE,Malamud JD,Casale RA,Cormick G,Belizán JM,Feasibility of “Mode of Delivery Trial” Study Group.

doi

10.1007/s10995-020-03073-4

subject

Has Abstract

pub_date

2021-01-01 00:00:00

pages

136-150

issue

eissn

1092-7875

issn

1573-6628

pii

10.1007/s10995-020-03073-4

journal_volume

pub_type

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Feasibility of Conducting a Trial Assessing Benefits and Risks of Planned Caesarean Section Versus Planned Vaginal Birth: A Cross-Sectional Study.