|
Related Publications & Presentations
Objective
- To determine the patient characteristics of women undergoing a trial
of labor (TOL) and to determine the efficacy and safety of trial of
labor.
- To determine the cesarean delivery rates, indications for operative
intervention, intrapartum patient management and outcome by payer and
provider status.
- To estimate the frequency of maternal and neonatal complications of
cesarean delivery.
- To determine factors influencing maternal and neonatal outcome in
women undergoing cesarean delivery.
Conclusion
To be determined
Clinical Centers
Magee Womens, Tennessee, Alabama, Wayne State, Cincinnati, Wake
Forest, Chicago, Ohio State, U of Miami, UTSW, UT-San Antonio, Utah,
Thomas Jefferson, Brown, Columbia, Case Western, UT-Houston,
UNC, Northwestern
Design
- Type
- Major Eligibility Criteria
- Cesarean section or successful VBAC
- ≥ 500 grams or ≥ 20 wks gestation
- Sample Size
- 10,800 TOL w/ 1 prior c-section
- 1,200 TOL w/ > 1 prior c-section
Scheduled Evaluations/Data Collections
- All deliveries
- Daily count of c-sections/VBAC and non VBAC vaginal
deliveries
Enrolled patients
- Delivery:
- Chart review for physical history, demographics, current
and previous pregnancy history, pregnancy complications,
labor and delivery, cesarean delivery
- Post delivery:
- Maternal chart review for postpartum complications, evaluations,
ICU admission, death
- Review of hospital admissions database for readmissions
Neonatal:
- Infant chart review for neonatal data, NICU admssions
Outcome Measures
- Primary
- Secondary
- Maternal morbidity and mortality
- Neonatal morbidity and mortality
Timetable
- Recruitment: 1/99-1/02
- Data Collection: 1/996-7/02
- Closeout/Final Analysis: 7/02-1/03
|