Pharmacokinetics of Progesterone in Pregnancy (PK-PiP)

Thomas Jefferson University

Status and phase

Completed

Phase 1

Conditions

Progesterone

Treatments

Drug: vaginal progesterone suppository

Study type

Interventional

Funder types

Other

Identifiers

NCT03340701

17D.559

Details and patient eligibility

About

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

Full 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 suppository. Serum progesterone levels will be drawn serially from pre-dose to 24 hours post-dose.

Enrollment

6 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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