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

The University of Texas System (UT)

Status: Withdrawn

Conditions: Placenta Accreta; Morbidly Adherent Placenta

Treatments: Other: Scheduled timing of delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT02635412

HSC-MS-16-0085

Details and patient eligibility

About

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

Full 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).

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts 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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Scheduled delivery at 34 weeks

Placebo Comparator group

Description:

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

Treatment:

Other: Scheduled timing of delivery

Scheduled delivery at 36 weeks

Active Comparator group

Description:

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

Treatment:

Other: Scheduled timing of delivery