Progesterone for the Management of Preterm, Premature Rupture of the Membranes: A Randomized Controlled Trial.

NCT01050647 | Completed Phase 1 Results

• 2 other identifiers: SU-01082010-468317976
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

Preterm birth is the leading cause of neonatal death and a significant cause of life long disability and health problems. It has been shown that the drug 17-hydroxyprogesterone caproate can help reduce the risk of preterm delivery in women with certain risk factors for preterm birth. We hope to learn whether this same medication can be used to prolong pregnancy in a group of patients in whom this medication has not been previously studied. Specifically, we hope to learn whether progesterone supplementation will delay delivery in women with pre-term, premature rupture of membranes (PPROM).

Conditions

Pregnancy Complications

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Achievement of 34 Weeks Gestation

  Delayed delivery until 34 weeks gestation.

  From enrollment until delivery, an average of 34 weeks

Secondary Outcomes (5)

• Number of Participants With Neonatal Respiratory Distress Syndrome

  From delivery until neonatal hospital discharge, assessed up to 2 months

• Number of Participants With Neonatal Grade III - IV Intraventricular Hemorrhage

  From delivery until neonatal hospital discharge, assessed up to 2 months

• Number of Participants With Neonatal Necrotizing Enterocolitis

  From delivery to neonatal discharge, assessed up to 2 months

• Neonatal Length of NICU and Total Hospital Stay Assessed as Number of Days

  From birth to discharge form delivery hospital, assessed up to 2 months

• Length of Latency Assessed as Number of Days

  From rupture of membranes until delivery, assessed up to 34 weeks of gestation

Study Arms (2)

17-hydroxyprogesterone caproate

ACTIVE COMPARATOR

Weekly injections of 17-hydroxyprogesterone caproate until patient reached 34 completed weeks of gestation

Drug: 17-Hydroxyprogesterone Caproate

Castor oil injections

PLACEBO COMPARATOR

Weekly injections of Caster Oil (placebo)

Other: Caster Oil injections

Interventions

17-Hydroxyprogesterone Caproate DRUG

Weekly injections of 17-hydroxyprogesterone caproate.

Also known as: Active study drug

17-hydroxyprogesterone caproate

Caster Oil injections OTHER

Weekly injection of Caster Oil (Placebo) until patient reached 34 weeks gestation.

Also known as: Placebo

Castor oil injections

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• yr of age
• Singleton pregnancy
• PPROM confirmed on clinical exam
• GA between 24+0 and 33+5 wk
• Ability to understand consent in either English or Spanish

You may not qualify if:

• Contraindication to ongoing pregnancy including:
• Evidence of active infection
• Evidence of significant placental abruption
• IUFD diagnosed at the time of P-PROM diagnosis
• Major fetal malformation
• Maternal allergy to progesterone or placebo drug components
• Current use of progesterone at the time of P-PROM
• Multiple Gestations
• Inability to understand consent in either English or Spanish

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Pregnancy Complications

Interventions

17 alpha-Hydroxyprogesterone Caproate

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

17-alpha-Hydroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Anna Girsen
• Organization: Stanford University

agirsen@stanford.edu

6507255720

Study Officials

• Yasser Y El-Sayed, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 13, 2010
• First Posted: January 15, 2010
• Study Start: February 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 9, 2019
• Results First Posted: April 17, 2018

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)