info:eu-repo/semantics/article
Feasibility of Conducting a Trial Assessing Benefits and Risks of Planned Caesarean Section Versus Planned Vaginal Birth: A Cross-Sectional Study
Registro en:
Amyx, Melissa Michele; Althabe, Fernando; Rivo, Julie; Pingray, María Verónica; Minckas, Nicole; et al.; Feasibility of Conducting a Trial Assessing Benefits and Risks of Planned Caesarean Section Versus Planned Vaginal Birth: A Cross-Sectional Study; Springer; Maternal and Child Health Journal; 25; 1; 1-2021; 136-150
1092-7875
1573-6628
CONICET Digital
CONICET
Autor
Amyx, Melissa Michele
Althabe, Fernando
Rivo, Julie
Pingray, María Verónica
Minckas, Nicole
Belizán, María
Gibbons, Luz
Murga, Gerardo T.
Fiorillo, Angel Eduardo
Malamud, Julio D.
Casale, Roberto A.
Cormick, Gabriela
Belizan, Jose
Resumen
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. Fil: Amyx, Melissa Michele. Instituto de Efectividad Clínica y Sanitaria; Argentina. University of Tulane; Estados Unidos Fil: Althabe, Fernando. University of Tulane; Estados Unidos. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina Fil: Rivo, Julie. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Pingray, María Verónica. University of Duke; Estados Unidos Fil: Minckas, Nicole. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Belizán, María. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; Argentina Fil: Murga, Gerardo T.. Instituto de Maternidad Y Ginecología Nuestra Señora de Las Mercedes; Argentina Fil: Fiorillo, Angel Eduardo. Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"; Argentina Fil: Malamud, Julio D.. Centro de Educación Medica E Invest.clinicas; Argentina Fil: Casale, Roberto A.. Sanatorio de la Mujer.; Argentina Fil: Cormick, Gabriela. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina. Hospital Nacional Profesor Alejandro Posadas; Argentina Fil: Belizan, Jose. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina