Overview
RCT of Progesterone to Prevent Preterm Birth in Nulliparous Women With a Short Cervix
Status:
Terminated
Terminated
Trial end date:
2011-12-01
2011-12-01
Target enrollment:
0
0
Participant gender:
Female
Female
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 early delivery and improves the health of their baby.Phase:
Phase 3Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The George Washington University Biostatistics CenterCollaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Treatments:
11-hydroxyprogesterone
17 alpha-Hydroxyprogesterone Caproate
17-alpha-hydroxy-progesterone caproate
Progesterone
Criteria
Inclusion Criteria:- 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 Criteria:
- 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