Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes

NCT04807543 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ppprom
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the efficacy of 17-hydroxyprogesterone caproate (17P) therapy on the latency period in pregnant women with Preterm premature rupture of membranes.

Conditions

Preterm Premature Rupture of Membrane

Outcome Measures

Primary Outcomes (1)

• prolongation of the pregnancy until a favorable gestational age

  The most common method of measuring gestational age in weeks is by calculating the time since the last menstrual period based on dates provided by a woman at the first prenatal visit IF not available first trimester Ultrasound will be used

  10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.)

Secondary Outcomes (2)

• Latency .

  10 to 12 weeks (interval in weeks from randomization to delivery)

• Composite neonatal morbidity

  1 week (from delivery to 1 week post Natal)

Study Arms (2)

study group

ACTIVE COMPARATOR

17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection

Drug: 17-hydroxyprogesterone caproate

control group

PLACEBO COMPARATOR

castor oil, 1 mL total volume intramuscular injection

Drug: Castor Oil

Interventions

17-hydroxyprogesterone caproate DRUG

intramuscular injection weekly

study group

Castor Oil DRUG

intramuscular injection weekly

control group

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• Gestational age between 24 and 34 weeks

You may not qualify if:

• Medical or obstetric conditions that could put them at risk for uterine atony , postpartum hemorrhage AND infection, such as
• Emergency Cesarean section.
• Chorioamnionitis.
• Placenta previa.
• Multiple gestation.
• Preeclampsia.
• Macrosomia.
• Non reassuring fetal status or fetal distress
• Presence of fetal anomalies incompatable with life
• Woman with antepartum haemorrhage
• Diagnosis of Established preterm labor

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

17 alpha-Hydroxyprogesterone Caproate; Castor Oil

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; Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2021
• First Posted: March 19, 2021
• Study Start: January 10, 2018
• Primary Completion: October 10, 2020
• Study Completion: December 10, 2020
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: starting 6 months after publication

Locations

EG (1)