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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02635412
Other study ID # HSC-MS-16-0085
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date March 2018

Study information

Verified date July 2018
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Scheduled timing of delivery


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type Measure Description Time frame Safety issue
Primary Composite neonatal morbidity Within 72 hours of newborn discharge
Primary Maternal neonatal morbidity Within 72 hours of patient discharge
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