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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Premature Rupture of Membrane
• Intervention / Treatment: Drug: 17-hydroxyprogesterone caproate; Drug: Castor Oil

Detailed Description

After taking informed written consent, the recruited patients will be subjected to the following:

1. Detailed history

   • Personal History: Name, age ,residence ,special habits of medical importance
   • Obstetric history: first day of last menstrual period for accurate estimation of gestational age and antenatal care
   • Past history: history of any medical disorder or surgical history with particular emphasis on prior PPROM or preterm labor
   • History of the present pregnancy: Medical or surgical condition to define high risk pregnancy.

2. Examination of the patients General examination: blood pressure, pulse, temperature

   Abdominal examination:

   • Inspection: fundal level, scars, umbilicus.
   • Palpation: presence of contractions, fetal lie and presentation.
   • Pelvic Examination only by sterile speculum to exclude cord prolapse , bloody liquor and cervical dilatation and effacement
   • Non stress test to ensure reassuring fetal well being

   • Ultrasound examination to:-

     • Assess fetal viability.
     • Amniotic fluid index.
     • Determine gestational age.
     • Exclude major anomalies.
     • Placental location.

3. Baseline laboratory investigations:

   • Complete blood count (CBC).
   • Prothrombin time (PT).
   • Activated partial thromboplastin time (aPTT).
   • Liver and kidney function.

The included patients were randomized using sealed opaque envelope method into one of two groups:

Group I (study group): in which 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume, intramuscular injection weekly) will be administered.

Group II (control group): in which an identical-appearing placebo (1 mL castor oil only) will be administered.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Singleton pregnancy
• Gestational age between 24 and 34 weeks

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: study group; 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection	Drug: 17-hydroxyprogesterone caproate; intramuscular injection weekly
PLACEBO_COMPARATOR: control group; castor oil, 1 mL total volume intramuscular injection	Drug: Castor Oil; intramuscular injection weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Latency .	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 (interval in weeks from randomization to delivery)
Composite neonatal morbidity	by Apgar score ,blood gases ,and labs	1 week (from delivery to 1 week post Natal)

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2018
• Primary Completion (ACTUAL): October 10, 2020
• Study Completion (ACTUAL): December 10, 2020

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (ACTUAL): March 19, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Estrogen Antagonists; Cathartics; Progestins; 17 alpha-Hydroxyprogesterone Caproate; 11-hydroxyprogesterone; Castor Oil
• Other Study ID Numbers: ppprom

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes