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

Autor: 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, Luz Gibbons
Rok vydání: 2021
Předmět:
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
Zdroj: Matern Child Health J
ISSN: 1573-6628
1092-7875
DOI: 10.1007/s10995-020-03073-4
Popis: 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.
Databáze: OpenAIRE
Externí odkaz: