Pharmacokinetics of Progesterone in Pregnancy-2

• Status: Recruiting
• Trial end date: 2022-07-02
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

• Lead Sponsor: Thomas Jefferson University
• Treatments: Progesterone

Criteria

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