Status:

TERMINATED

Pharmacokinetics of Progesterone in Pregnancy-2

Lead Sponsor:

Thomas Jefferson University

Conditions:

Pregnancy Related

Eligibility:

FEMALE

16-55 years

Phase:

PHASE1

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 p...

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 preg...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

January 7 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2022

Estimated Enrollment :

3 Patients enrolled

Trial Details

Trial ID

NCT04753957

Start Date

January 7 2022

End Date

February 1 2022

Last Update

May 26 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107