RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Preterm Delivery, Cervical Length
In brief
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 early delivery and improves the health of their baby.
Key facts
- Study ID
- NCT00439374
- Run by
- The George Washington University Biostatistics Center
- People needed
- 657
- Starts
- 2007-04-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2019-07-15
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama - Birmingham — Birmingham, Alabama, United States
- Northwestern University-Prentice Hospital — Chicago, Illinois, United States
- Dept of OB/GYN, Hutzel Hospital — Detroit, Michigan, United States
- Columbia University-St. Luke's Hospital — New York, New York, United States
- University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
- Case Western Reserve-Metrohealth — Cleveland, Ohio, United States
- Ohio State University Hospital — Columbus, Ohio, United States
- Oregon Health & Sciences University — Portland, Oregon, United States
- University of Pittsburgh-Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
- Brown University -Women and Infants Hospital — Providence, Rhode Island, United States
- Dept of OB/GYN, Southwestern Medical Center, University of Texas — Dallas, Texas, United States
- University of Texas Medical Branch - Galveston — Galveston, Texas, United States
- University of Texas-Houston — Houston, Texas, United States
- University of Utah Medical Center — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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