1. Feasibility of Conducting a Trial Assessing Benefits and Risks of Planned Caesarean Section Versus Planned Vaginal Birth: A Cross-Sectional Study
- Author
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Fernando Althabe, Nicole Minckas, Gabriela Cormick, Veronica Pingray, José M. Belizán, Julio D Malamud, Melissa Amyx, Julie Rivo, María Belizán, Gerardo T Murga, A.E. Fiorillo, Roberto A Casale, and Luz Gibbons
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Epidemiology ,Health Personnel ,medicine.medical_treatment ,Population ,Argentina ,Prenatal care ,Risk Assessment ,Article ,law.invention ,Cohort Studies ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Pregnancy ,law ,Informed consent ,Elective Cesarean Delivery ,medicine ,Humans ,Caesarean section ,030212 general & internal medicine ,education ,education.field_of_study ,030219 obstetrics & reproductive medicine ,Cesarean Section ,business.industry ,Vaginal delivery ,Public Health, Environmental and Occupational Health ,Obstetrics and Gynecology ,Patient Preference ,Middle Aged ,Delivery, Obstetric ,Delivery mode ,Cross-Sectional Studies ,Elective Surgical Procedures ,Family medicine ,Pediatrics, Perinatology and Child Health ,Feasibility Studies ,Female ,business - 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 (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.
- Published
- 2021