Pharmacokinetics of Progesterone in Pregnancy

• Status: Completed
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: Female

Summary

Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Progesterone

Criteria

Inclusion Criteria:

• ≥18 years old pregnant with singleton gestation 16 0/7 - 23 6/7 weeks

• pre-pregnancy BMI 20-40

• no history of prior preterm birth

Exclusion Criteria:

• history of an adverse reaction to progesterone

• contraindication to progesterone treatment including prior or active thrombus, active hepatic disease, known adverse reaction to progesterone

• medical comorbidity requiring medication including: hypertension, diabetes, substance abuse/methadone maintenance therapy, asthma, thyroid disease

• major fetal anomaly diagnosed on ultrasound or known chromosomal disorder

• multifetal gestation

• vaginal bleeding, preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment or on Day 1 of study

• any progesterone use of any form previously during the pregnancy

• active vaginitis

• Illicit substance use in pregnancy including cocaine, opiates, marijuana

• abnormal pap smear/+HPV on most recent pap smear

• known or suspected malignancy of the breast or genital organs

• cervical length ≤25mm