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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 6, 2018

Status Verified

July 1, 2018

Enrollment Period

2 years

First QC Date

December 16, 2015

Last Update Submit

July 3, 2018

Conditions

Morbidly Adherent PlacentaPlacenta Accreta

Keywords

PlacentaAccretaMorbidlyAdherent Placenta

Outcome Measures

Primary Outcomes (2)

  • Composite neonatal morbidity

    Within 72 hours of newborn discharge

  • Maternal neonatal morbidity

    Within 72 hours of patient discharge

Study Arms (2)

Scheduled delivery at 34 weeks

PLACEBO COMPARATOR

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

Other: Scheduled timing of delivery

Scheduled delivery at 36 weeks

ACTIVE COMPARATOR

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

Other: Scheduled timing of delivery

Interventions

Scheduled timing of deliveryOTHER
Scheduled delivery at 34 weeksScheduled delivery at 36 weeks

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with monographically morbidly adherent placenta with or without a placenta previa.
  • Scheduled delivery via cesarean hysterectomy

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 18, 2015

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 6, 2018

Record last verified: 2018-07