Status:
COMPLETED
The Use of Progesterone to Reduce Preterm Birth
Lead Sponsor:
University of Mississippi Medical Center
Conditions:
Preterm Birth
Eligibility:
FEMALE
16-45 years
Phase:
NA
Brief Summary
Preterm birth is the most common and costly complication in obstetrics. It complicates up to 11 % of all pregnancies and it is responsible for 70% of sick babies. Recently two studies have shown that ...
Detailed Description
A. Introduction Preterm birth occurs in 7-12% of all deliveries, but accounts for over 85% of all perinatal morbidity and mortality.1 Despite many strategies for reducing the incidence of preterm birt...
Eligibility Criteria
Inclusion
- Pregnancy 20 - 34 weeks; cervical dilation \<4 cm; risk for preterm birth; multifetal gestation; diagnosis of preterm labor during the current pregnancy effectively tocolyzed); preterm rupture of the fetal membranes (24 - 34 weeks); willing and able to sign Informed Consent Form
Exclusion
- Failure to meet inclusion criteria as noted above; contraindication to pregnancy continuation; severe medical diseases such as sickle cell disease with crises, diabetes mellitus (F/R/H), severe preeclampsia etc., (physician judgment; severe fetal/obstetric criteria such as intrauterine growth restriction (\<5th percentile, placental abruption,placental previa, etc., (physician judgment); non reassuring fetal assessment; allergy to progesterone compounds; refusal to participate
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00830765
Start Date
June 1 2004
End Date
June 1 2010
Last Update
February 20 2013
Active Locations (1)
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1
Winfred L Wiser Hospital for Women and Infants at the University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216