Status:
WITHDRAWN
Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate
Lead Sponsor:
Yale University
Conditions:
Premature Birth
Premature Labor
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of our research will be to determine the effectiveness of 17 alpha-hydroxyprogesterone caproate (17P) in the treatment of preterm delivery. Treatment with progesterone is emerging as the stan...
Detailed Description
Preterm delivery remains one of the most important issues facing perinatal medicine today. In 1999, prematurity/low birthweight accounted for 4,304 neonatal deaths, reflecting a rate of neonatal morta...
Eligibility Criteria
Inclusion
- Patients in preterm labor as described above.
- Patients with an accurately dated singleton gestation. Accurate dating is defined as estimated date of delivery (EDD) based on last menstrual period (LMP) dating (280 days after the first day of the LMP) confirmed by an ultrasound done before 20 weeks, which yields an EDD within 10 days of LMP dating. If the LMP is not available, the EDD must be based on 2 ultrasounds performed at least 2 weeks apart, which are concordant within 5 days of the same EDD.
- Patients with their first presentation of preterm labor will be invited to participate.
- Patients whose plan of management includes admission to the hospital and administration of antenatal steroids for fetal well being.
Exclusion
- Rupture of membranes
- Major known fetal anomalies
- Cervical dilation \> 4 centimeters
- Uterine anomalies
- Cervical cerclage
- Treatment during this pregnancy with progesterone after 14 weeks' gestation (use up to 14 weeks' gestation is permitted)
- Previous admission for preterm labor
- Contraindications to tocolysis, including fetal distress, chorioamnionitis, preeclampsia, hemodynamic instability
- Coexisting maternal disease including hypertension requiring medical therapy, cancer, seizure disorder, thromboembolic disorders, liver disease. Patients treated with oral beta adrenergics for asthma are also excluded.
- Age \< 18 years
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00120640
Start Date
July 1 2005
Last Update
September 19 2012
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