Delivery Timing in Morbidly Adherent Placentas: a Randomized, Controlled Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-03-31

Brief Summary

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This is a randomized controlled trial to investigate the optimal timing of delivery in clinically stable women with a suspected morbidly adherent placenta.

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Detailed Description

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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).

Conditions

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Morbidly Adherent Placenta Placenta Accreta

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Scheduled delivery at 34 weeks

Scheduled delivery at 34 weeks (range 33 weeks 5 days to 34 weeks 3 days)

Group Type PLACEBO_COMPARATOR

Scheduled timing of delivery

Intervention Type OTHER

Scheduled delivery at 36 weeks

Scheduled delivery at 36 weeks (range 35 weeks 5 days to 36 weeks 3 days)

Group Type ACTIVE_COMPARATOR

Scheduled timing of delivery

Intervention Type OTHER

Interventions

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Scheduled timing of delivery

Intervention Type OTHER

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes