Study of Pharmacology of 17-OHPC in Pregnancy

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

We are examining the pharmacology of 17-OHPC in pregnancy, specifically between the second and third trimesters.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Treatments: 11-hydroxyprogesterone; 17 alpha-Hydroxyprogesterone Caproate; 17-alpha-hydroxy-progesterone caproate

Criteria

Inclusion Criteria:

• Singleton gestation prior to 20 0/7 weeks gestation

• Planning to receive or receiving 17-OHPC (250 mg IM weekly)

• Previous history of preterm birth

• Able to give consent

Exclusion Criteria:

• Fetal demise, anomaly, or growth restriction

• Hepatic or renal dysfunction

• Placental previa or abruptio placenta

• Polyhydramnios/oligohydramnios

• Short cervix or planned cerclage

• Chronic use of steroids, antiepileptics, antihypertensives, SSRS, street drugs

• Participation in another interventional study that influences gestational age at delivery

• Heparin treatment of known platelet count <100,000/mm3 (because of contraindication to intra-muscular injections)