Pharmacokinetics of Progesterone in Pregnancy-2

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04753957

Acronym

PiP-2

Enrollment

Registered

2021-02-15

Start date

2022-01-07

Completion date

2022-02-01

Last updated

2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Related

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.

Interventions

DRUGmicronized Progesterone

200mg micronized progesterone placed vaginally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Side effect survey	24hr after delivery	survey of side effects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026