Delivery Timing in Morbidly Adherent Placentas: a Randomized, Controlled Trial
Not Applicable
Withdrawn
- Conditions
- Placenta AccretaMorbidly Adherent Placenta
- Interventions
- Other: Scheduled timing of delivery
- Registration Number
- NCT02635412
- Brief Summary
This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta.
- Detailed Description
This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta dispositioned for a scheduled delivery. The primary outcome will be assessed by comparing the composite neonatal morbidity and composite maternal morbidity between the two groups (delivery at 34 versus 36 weeks gestational age).
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Women with monographically morbidly adherent placenta with or without a placenta previa.
- Scheduled delivery via cesarean hysterectomy
Exclusion Criteria
- Delivery planned prior to 36 weeks (e.g. non-reassuring fetal status, preterm labor, severe preeclampsia, other medical/fetal indication for delivery as determined by the managing physician).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Scheduled delivery at 34 weeks Scheduled timing of delivery Scheduled delivery at 34 weeks (range 33 weeks 5 days to 34 weeks 3 days) Scheduled delivery at 36 weeks Scheduled timing of delivery Scheduled delivery at 36 weeks (range 35 weeks 5 days to 36 weeks 3 days)
- Primary Outcome Measures
Name Time Method Maternal neonatal morbidity Within 72 hours of patient discharge Composite neonatal morbidity Within 72 hours of newborn discharge
- Secondary Outcome Measures
Name Time Method