Status:
TERMINATED
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Preterm Delivery
Cervical Length
Eligibility:
FEMALE
Phase:
PHASE3
Brief Summary
The purpose of this study is to see if giving progesterone medication to pregnant women, who have never delivered a baby after 19 weeks of pregnancy and who have a short cervix, lowers the risk of ear...
Detailed Description
Preterm births, defined as the delivery of a baby less than 37 weeks of gestation, are responsible for the majority of neonatal mortality and morbidities. Studies have shown that a number of risk fact...
Eligibility Criteria
Inclusion
- Nulliparous
- Cervical length as measured on transvaginal examination \< 30mm between gestational ages of 16 weeks 0 days to 22 weeks 3 days
- Gestational age 16 weeks 3 days to 22 weeks 6 days at time of randomization
Exclusion
- Multifetal gestation
- Progesterone treatment after 14 weeks 6 days during current pregnancy
- Vaginal bleeding, heavier than spotting, after 15 weeks 6 days
- Amniotic membranes prolapsed beyond external os
- Preterm rupture of membranes
- Fetal anomaly
- Pregnancy without a viable fetus
- Current or planned cervical cerclage
- Congenital Mullerian abnormality of the uterus
- Contraindication to intra-muscular injections
- Hypertension requiring medication
- Diabetes managed with insulin or oral hypoglycemic agents
- DES exposure
- Cervical surgery such as cold knife conization
- Planned indicated preterm delivery
- Participation in another interventional study that influences age at delivery
- Participation in this trial in a previous pregnancy
- Prenatal care or delivery planned outside a MFMU Network center
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
657 Patients enrolled
Trial Details
Trial ID
NCT00439374
Start Date
April 1 2007
End Date
December 1 2011
Last Update
July 15 2019
Active Locations (14)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35429
2
Northwestern University-Prentice Hospital
Chicago, Illinois, United States, 60611
3
Dept of OB/GYN, Hutzel Hospital
Detroit, Michigan, United States, 48201
4
Columbia University-St. Luke's Hospital
New York, New York, United States, 10032