Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT01119963

Progesterone (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM) (17PinPROM)

17-alpha-Hydroxyprogesterone Caproate (17P, Makena®) for Prolongation of Pregnancy in Women With Preterm Rupture of the Membranes (PROM), Double-blinded Randomized Clinical Trial

Sponsor: Obstetrix Medical Group

Conditions Preterm Delivery

Interventions 17-alpha-hydroxy-progesterone caproate, Makena® Castor Oil (Placebo)

Updated 10 times since 2017 Last updated: May 29, 2018 Started: Oct 31, 2011 Primary completion: Apr 30, 2014 Completion: Oct 31, 2014

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2/PHASE3 trial investigates Preterm Delivery and is currently completed. Obstetrix Medical Group leads this study, which shows 10 recorded versions since 2011 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

10 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2/PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2/PHASE3

Phase: PHASE2_PHASE3 → PHASE2/PHASE3
Jan 2023 — Jul 2024 [monthly]

Completed PHASE2_PHASE3
Dec 2021 — Jan 2023 [monthly]

Completed PHASE2_PHASE3
Jan 2021 — Dec 2021 [monthly]

Completed PHASE2_PHASE3

▶ Show 5 earlier versions

Jul 2018 — Jan 2021 [monthly]

Completed PHASE2_PHASE3
Jun 2018 — Jul 2018 [monthly]

Completed PHASE2_PHASE3
Feb 2018 — Jun 2018 [monthly]

Completed PHASE2_PHASE3
Feb 2017 — Feb 2018 [monthly]

Completed PHASE2_PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2_PHASE3

First recorded

Oct 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Obstetrix Medical Group

Data source: Pediatrix

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Cincinnati, United States , Denver, United States , Grand Rapids, United States , Kansas City, United States , Las Vegas, United States , Long Beach, United States , Louisville, United States , Mesa, United States , Mobile, United States , Phoenix, United States and 3 more locations