Pharmacokinetics of Progesterone in Pregnancy-2

Pregnancy Related Clinical Trial

— PiP-2  

Official title:

Pharmacokinetics of Progesterone in Pregnancy-2

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04753957
• Other study ID #: 20D.1094
• Status: Terminated
• Phase: Phase 1
• Start date: January 7, 2022
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2022
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Drug:
• micronized Progesterone
200mg micronized progesterone placed vaginally

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endometrial (ng/mg) progesterone time/concentration profile	Concentration of progesterone in endometrium, sampled at time of scheduled c-section	12 hours
Primary	Plasma (ng/ml) progesterone time/concentration profile	concentration of serum progesterone, sampled at time of scheduled c-section	12 hours
Secondary	Side effect survey	survey of side effects	24hr after delivery