Melissa M Amyx1,2, Fernando Althabe3, Julie Rivo4, Verónica Pingray3, Nicole Minckas3, María Belizán3, Luz Gibbons3, Gerardo T Murga5, Ángel E Fiorillo6, Julio D Malamud7, Roberto A Casale8, Gabriela Cormick3, José M Belizán3. 1. School of Public Health and Tropical Medicine, Tulane University, 1440 Canal St., #2400, New Orleans, LA, 70112, USA. mamyx@tulane.edu. 2. Mother and Child's Health Research Department, Institute for Clinical Effectiveness and Health Policy (IECS-CONICET), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina. mamyx@tulane.edu. 3. Mother and Child's Health Research Department, Institute for Clinical Effectiveness and Health Policy (IECS-CONICET), Dr. Emilio Ravignani 2024 (C1414CPV), Buenos Aires, Argentina. 4. Duke University School of Medicine, Duke University, 8 Duke University Medical Center Greenspace, Durham, NC, 27703, USA. 5. Instituto de Maternidad Y Ginecología Nuestra Señora de Las Mercedes, Av. Mate de Luna 1535, 4000, San Miguel de Tucumán, Tucumán Province, Argentina. 6. Centro de Educación Médica E Investigaciones Clínicas "Norberto Quirno" (CEMIC), Av. E. Galván 4102, C1431FWO, Buenos Aires, Argentina. 7. Sanatorio de La Mujer, San Luis 2493, S2002, Rosario, Santa Fe, Argentina. 8. Hospital Nacional A. Posadas, El Palomar, Buenos Aires, Argentina.
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.
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.
Authors: Catherine E Turner; Jane M Young; Michael J Solomon; Joanne Ludlow; Christopher Benness; Hala Phipps Journal: Aust N Z J Obstet Gynaecol Date: 2008-12 Impact factor: 2.100
Authors: Jon F R Barrett; Mary E Hannah; Eileen K Hutton; Andrew R Willan; Alexander C Allen; B Anthony Armson; Amiram Gafni; K S Joseph; Dalah Mason; Arne Ohlsson; Susan Ross; J Johanna Sanchez; Elizabeth V Asztalos Journal: N Engl J Med Date: 2013-10-03 Impact factor: 91.245
Authors: J C Rivo; M Amyx; V Pingray; R A Casale; A E Fiorillo; H B Krupitzki; J D Malamud; M Mendilaharzu; M L Medina; A B Del Pino; L Ribola; J A Schvartzman; G M Tartalo; M Trasmonte; S Varela; F Althabe; J M Belizán Journal: BJOG Date: 2018-02-22 Impact factor: 6.531