Study Stopped
Difficulty with endometrial sample collection. New study design to be prospective observational to validate reliable methods of endometrial sampling at time of c-section.
Pharmacokinetics of Progesterone in Pregnancy-2
PiP-2
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedStudy Start
First participant enrolled
January 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedMay 26, 2022
May 1, 2022
25 days
February 9, 2021
May 24, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Endometrial (ng/mg) progesterone time/concentration profile
Concentration of progesterone in endometrium, sampled at time of scheduled c-section
12 hours
Plasma (ng/ml) progesterone time/concentration profile
concentration of serum progesterone, sampled at time of scheduled c-section
12 hours
Secondary Outcomes (1)
Side effect survey
24hr after delivery
Study Arms (2)
Vaginal progesterone
ACTIVE COMPARATOR200mg micronized vaginal progesterone placed 7am prior to scheduled cesarean delivery
Control
NO INTERVENTIONNo intervention, scheduled cesarean delivery
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18yo
- Singleton gestation, ≥36 0/7 weeks gestation
- Scheduled cesarean delivery at Thomas Jefferson University Hospital or affiliate
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 15, 2021
Study Start
January 7, 2022
Primary Completion
February 1, 2022
Study Completion
February 1, 2022
Last Updated
May 26, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Following trial completion and publication
- Access Criteria
- Data sharing agreement
IPD may be requested following trial completion and publication with appropriate data sharing agreement.