Pharmacokinetics of Progesterone in Pregnancy-2

Phase 1

Terminated

• Conditions: Pregnancy Related
• Interventions: Drug: micronized Progesterone

• Registration Number: NCT04753957
• Lead Sponsor: Thomas Jefferson University

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 Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-15
• Study Start: 2022-01-07
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

Inclusion Criteria

• Age ≥18yo
• Singleton gestation, ≥36 0/7 weeks gestation
• Scheduled cesarean delivery at Thomas Jefferson University Hospital or affiliate

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vaginal progesterone	micronized Progesterone	200mg micronized vaginal progesterone placed 7am prior to scheduled cesarean delivery

Primary Outcome Measures

Name	Time	Method
Endometrial (ng/mg) progesterone time/concentration profile	12 hours	Concentration of progesterone in endometrium, sampled at time of scheduled c-section
Plasma (ng/ml) progesterone time/concentration profile	12 hours	concentration of serum progesterone, sampled at time of scheduled c-section

Secondary Outcome Measures

Name	Time	Method
Side effect survey	24hr after delivery	survey of side effects

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States