Pharmacokinetics of Progesterone in Pregnancy-2 (PiP-2)

May 24, 2022 updated by: Thomas Jefferson University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endometrial (ng/mg) progesterone time/concentration profile
Time Frame: 12 hours
Concentration of progesterone in endometrium, sampled at time of scheduled c-section
12 hours
Plasma (ng/ml) progesterone time/concentration profile
Time Frame: 12 hours
concentration of serum progesterone, sampled at time of scheduled c-section
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effect survey
Time Frame: 24hr after delivery
survey of side effects
24hr after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 7, 2022

Primary Completion (ACTUAL)

February 1, 2022

Study Completion (ACTUAL)

February 1, 2022

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (ACTUAL)

February 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20D.1094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD may be requested following trial completion and publication with appropriate data sharing agreement.

IPD Sharing Time Frame

Following trial completion and publication

IPD Sharing Access Criteria

Data sharing agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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