Pharmacokinetics of Progesterone in Pregnancy-2

NCT ID: NCT04753957

Last Updated: 2022-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-07

Study Completion Date

2022-02-01

Brief Summary

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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

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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.

Conditions

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Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Vaginal progesterone

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

Group Type ACTIVE_COMPARATOR

micronized Progesterone

Intervention Type DRUG

200mg micronized progesterone placed vaginally

Control

No intervention, scheduled cesarean delivery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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micronized Progesterone

200mg micronized progesterone placed vaginally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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20D.1094

Identifier Type: -

Identifier Source: org_study_id

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