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. 2021 Jan;25(1):136-150.
doi: 10.1007/s10995-020-03073-4. Epub 2021 Jan 3.

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

Melissa M Amyx  1   2 , Fernando Althabe  3 , Julie Rivo  4 , Verónica Pingray  3 , Nicole Minckas  3 , María Belizán  3 , Luz Gibbons  3 , Gerardo T Murga  5 , Ángel E Fiorillo  6 , Julio D Malamud  7 , Roberto A Casale  8 , Gabriela Cormick  3 , José M Belizán  3 ; Feasibility of “Mode of Delivery Trial” Study Group
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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

Melissa M Amyx et al. Matern Child Health J. 2021 Jan.

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.

Keywords: Elective cesarean delivery; Partially randomized patient preference trial; Preference controlled trial; Randomized controlled trial; Vaginal delivery.

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Conflict of interest statement

Conflict of interest statement: The authors declare that they have no conflict of interest.

Figures

Figure 1.
Figure 1.
Participant Flowchart for Study Recruitment (Screening, Consent, and Enrollment) of Pregnant Women *Could have been excluded for multiple reasons
See this image and copyright information in PMC

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