Phase 2 N=61 Basic Science

Study of Pharmacology of 17-OHPC in Pregnancy

Pregnancy

Bottom Line

View on ClinicalTrials.gov: NCT00409825 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy. — 115; 136 ng/ML/day

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 17-OHPC (Drug); Blood Draws (Procedure)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Pittsburgh
Primary completion: Apr 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Area Under the Concentration vs. Time Curve in the Second and Third Trimesters of Pregnancy.	115; 136	—

Summary

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

Eligibility 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00409825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.