Pharmacokinetics of Progesterone in Pregnancy-2
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Thomas Jefferson University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Endometrial (ng/mg) progesterone time/concentration profile
Study Overview
Brief Summary
The objective of this study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.
Detailed Description
The objective of this pilot study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 16 Years to 55 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age ≥18yo
- •Singleton gestation, ≥36 0/7 weeks gestation
- •Scheduled cesarean delivery at Thomas Jefferson University Hospital or affiliate
Exclusion Criteria
- •Contraindication to vaginal progesterone suppository
- •Active hepatic disease
- •Prior or current thrombus
- •Known adverse reaction to progesterone
- •Peanut allergy
- •Bleeding disorder (such as thrombophilia)
- •Use of 17-hydroxyprogesterone caproate in the pregnancy
- •Use of vaginal progesterone in the pregnancy
- •History of adverse reaction to progesterone
- •Current vaginitis
Arms & Interventions
Vaginal progesterone
200mg micronized vaginal progesterone placed 7am prior to scheduled cesarean delivery
Intervention: micronized Progesterone (Drug)
Outcomes
Primary Outcomes
Endometrial (ng/mg) progesterone time/concentration profile
Time Frame: 12 hours
Concentration of progesterone in endometrium, sampled at time of scheduled c-section
Plasma (ng/ml) progesterone time/concentration profile
Time Frame: 12 hours
concentration of serum progesterone, sampled at time of scheduled c-section
Secondary Outcomes
- Side effect survey(24hr after delivery)