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

Primary Purpose

Morbidly Adherent Placenta, Placenta Accreta

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Scheduled timing of delivery
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Morbidly Adherent Placenta focused on measuring Placenta, Accreta, Morbidly, Adherent Placenta

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Scheduled delivery at 34 weeks

    Scheduled delivery at 36 weeks

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Composite neonatal morbidity
    Maternal neonatal morbidity

    Secondary Outcome Measures

    Full Information

    First Posted
    December 16, 2015
    Last Updated
    July 3, 2018
    Sponsor
    The University of Texas Health Science Center, Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02635412
    Brief Title
    Delivery Timing in Morbidly Adherent Placentas: a Randomized, Controlled Trial
    Acronym
    MAP
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Never approved by the IRB
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    March 2018 (Anticipated)
    Study Completion Date
    March 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Health Science Center, Houston

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbidly Adherent Placenta, Placenta Accreta
    Keywords
    Placenta, Accreta, Morbidly, Adherent Placenta

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Scheduled delivery at 34 weeks
    Arm Type
    Placebo Comparator
    Arm Description
    Scheduled delivery at 34 weeks (range 33 weeks 5 days to 34 weeks 3 days)
    Arm Title
    Scheduled delivery at 36 weeks
    Arm Type
    Active Comparator
    Arm Description
    Scheduled delivery at 36 weeks (range 35 weeks 5 days to 36 weeks 3 days)
    Intervention Type
    Other
    Intervention Name(s)
    Scheduled timing of delivery
    Primary Outcome Measure Information:
    Title
    Composite neonatal morbidity
    Time Frame
    Within 72 hours of newborn discharge
    Title
    Maternal neonatal morbidity
    Time Frame
    Within 72 hours of patient discharge

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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).

    12. IPD Sharing Statement

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

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