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.

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Acknowledgements

We are grateful to the women and healthcare professionals who participated in this study. We thank Dr. Agustina Mazzoni (IECS) for sharing survey instruments and other materials used in her study, the “Women’s preferences and mode of delivery in public and private hospitals: a prospective cohort study.” Dr. Amyx thanks her dissertation committee members for their guidance (Xu Xiong, MD, DrPH [chair], Gretchen Clum, PhD, and Pierre Buekens, MD, PhD [Tulane University]). We could not have done this study without the collaboration and dedication of the Feasibility of ‘Mode of Delivery Trial’ Study Group. This study was funded by the National Institutes of Health Training in Global Reproductive Epidemiology grant (5T32HD057780); National Institutes of Health Office of the Director, Fogarty International Center, Office of AIDS Research, National Cancer Center, National Heart, Blood, and Lung Institute, and the National Institutes of Health Office of Research for Women’s Health through the Fogarty Global Health Fellows Program Consortium comprised of the University of North Carolina, John Hopkins, Morehouse and Tulane (R25TW009340); Health Resources & Services Administration/Maternal & Child Health Bureau Maternal and Child Health Epidemiology Doctoral Training Program (#T03MC07649).

Collaborators for the Feasibility of ‘Mode of Delivery Trial’ Study Group

Study coordinating group: Dr. Melissa Amyx (PI); Dr. José M. Belizán (Co-Investigator); Julie Rivo (Sub-Investigator); Dr. Fernando Althabe, Verónica Pingray, Gabriela Cormick, Nicole Minckas Qualitative/pilot phase coordination group: María Belizán, Ana Becu. Data management/coordination: Dr. Mabel Berrueta (coordination); Luz Gibbons (survey development and data analysis); Alvaro Ciganda (technical support); Candela Stella, Paula Rubinstein (data management). Participating hospitals and staff: Centro de Educación Médica e Investigaciones Clínicas “Norberto Quirno” (CEMIC), Autonomous City of Buenos Aires, Argentina: Dr. Angél E. Fiorillo (Hospital-based PI); Dr. Hugo B. Krupitzki, Dr. Javier A. Schvartzman (Hospital-based Co-investigators); Dr. Karen Tapper (Coordinator qualitative phase); Nora Viergue, Mariana Piola Sanatorio de la Mujer, Rosario, Santa Fe, Argentina: Dr. Julio D. Malamud (Hospital-based PI); Dr. Mauricio Belizán (Co-Investigator); Alicia Beatriz del Pino (Co-Investigator, Coordinator); Pablo Quaranta; Julieta Malamud; Marianela Oriti; Gonzalo Molina; Patricia Ahumada; Leandro Biancofiore. Instituto de la Maternidad y Ginecología Nuestra Señora de las Mercedes, San Miguel de Tucumán, Tucumán, Argentina: Dr. Gerardo Murga Tartalo (Hospital-based PI); Dr. María Lucía Medina, Dr. María Mendilaharzu (Co-investigators, Coordinators); Dr. Elena Hurtado, Susana Gil, Dr. Lucía Inés Barcatt Mirande, Dr. Laissa Antonella Avellaneda, Dr. María Eugenia Moyano, Dr. Evelyn Geanette Llano P., Dr. Carla Díaz Martín, Dr. Viviana Goldina Jaitt, Dr. M. Valentina Giraldez, Dr. Melina Julian, Dr. Antonella Gisel Quintana, Dr. Lourdes Alicia Bravo, Dr. Gabriela Alejandra Olavarría Mendez, Dr. Diego Martín Rongetti, Dr. Lourdes Solange Venegas Tarancón, Dr. Luciana Andrea Carrizo, Dr. Federico Coria, Dr. Analía Soledad Carrizo. Hospital Nacional A. Posadas, El Palomar, Buenos Aires, Argentina: Dr. Roberto A. Casale (Hospital-based PI); Silvana Varela, Mónica Trasmonte (Hospital-based Co-investigator, Coordinator); Dr. Lucio Ribola (Coordinator), Analia Mereles, Gabriela Violano, Milena Losardo, Vanina Lauphan, Yesica Lombardo.

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Correspondence to Melissa M. Amyx.

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The study research protocol was approved by the appropriate ethics committees, including the Institutional Review Boards of Tulane University and Duke University and by local hospital ethics committees (CEMIC; Posadas Hospital). The study was conducted in accordance with the ethical standards of the Declaration of Helsinki.

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All participants gave written informed consent prior to participation.

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The members for the Feasibility of “Mode of Delivery Trial” Study Group are listed in “Acknowledgements”.

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Amyx, M.M., Althabe, F., Rivo, J. et al. Feasibility of Conducting a Trial Assessing Benefits and Risks of Planned Caesarean Section Versus Planned Vaginal Birth: A Cross-Sectional Study. Matern Child Health J 25, 136–150 (2021). https://doi.org/10.1007/s10995-020-03073-4

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Keywords

  • Elective cesarean delivery
  • Partially randomized patient preference trial
  • Preference controlled trial
  • Randomized controlled trial
  • Vaginal delivery