Treatment of Preterm Labor With 17 Alpha-hydroxyprogesterone Caproate

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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 standard of care for prevention of preterm delivery in asymptomatic patients at high risk for preterm birth due to a prior preterm delivery. Our goal is to evaluate whether or not progesterone is also effective in reducing preterm birth in symptomatic patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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