Delivery Timing in Morbidly Adherent Placentas: a Randomi... | NCT02635412

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

NCT02635412

Sponsor

The University of Texas Health Science Center, Houston

Status

Withdrawn

Last Update Posted

Jul 6, 2018Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Morbidly Adherent Placenta
Placenta Accreta

Interventions

Scheduled timing of delivery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Never approved by the IRB

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Mar 2018Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Dec 16, 2015

First Submission Date that Met QC Criteria

Dec 17, 2015

First Posted Date

Dec 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2018

Last Update Posted Date

Jul 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Scheduled timing of delivery	Other		Scheduled delivery at 34 weeks Scheduled delivery at 36 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite neonatal morbidity		Within 72 hours of newborn discharge
Maternal neonatal morbidity		Within 72 hours of patient discharge

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010921	Placenta Accreta

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided