Status:
COMPLETED
Pharmacokinetics of Progesterone in Pregnancy
Lead Sponsor:
Thomas Jefferson University
Conditions:
Progesterone
Eligibility:
FEMALE
18-55 years
Phase:
PHASE1
Brief Summary
Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation
Detailed Description
Prospective study of 6 women with singleton pregnancies 18 0/7- 23 6/7 weeks' gestation with no prior preterm birth or short cervix who are administered a single dose of 200mg vaginal progesterone sup...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03340701
Start Date
November 6 2017
End Date
June 30 2018
Last Update
February 20 2020
Active Locations (1)
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1
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107