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PiP-2: Pharmacokinetics of Progesterone in Pregnancy-2

Sponsor
Thomas Jefferson University (Other)
Overall Status
Terminated
CT.gov ID
NCT04753957
Collaborator
(none)
3
Enrollment
1
Location
2
Arms
25
Actual Duration (Days)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: micronized Progesterone
 Phase 1

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
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pharmacokinetics of Progesterone in Pregnancy-2
Actual Study Start Date :
Jan 7, 2022
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Vaginal progesterone

200mg micronized vaginal progesterone placed 7am prior to scheduled cesarean delivery

Drug: micronized Progesterone
200mg micronized progesterone placed vaginally
No Intervention: Control

No intervention, scheduled cesarean delivery

Outcome Measures

Primary Outcome Measures

  1. Endometrial (ng/mg) progesterone time/concentration profile [12 hours]

    Concentration of progesterone in endometrium, sampled at time of scheduled c-section

  2. Plasma (ng/ml) progesterone time/concentration profile [12 hours]

    concentration of serum progesterone, sampled at time of scheduled c-section

Secondary Outcome Measures

  1. Side effect survey [24hr after delivery]

    survey of side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 55 Years
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT04753957
Other Study ID Numbers:
  • 20D.1094
First Posted:
Feb 15, 2021
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Progesterone

Study Results

No Results Posted as of May 26, 2022