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

NCT ID: NCT04807543

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2020-12-10

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.

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.

Conditions

Preterm Premature Rupture of Membrane

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

study group

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

Group Type: ACTIVE_COMPARATOR

17-hydroxyprogesterone caproate

Intervention Type: DRUG

intramuscular injection weekly

control group

castor oil, 1 mL total volume intramuscular injection

Group Type: PLACEBO_COMPARATOR

Castor Oil

Intervention Type: DRUG

intramuscular injection weekly

Interventions

17-hydroxyprogesterone caproate

intramuscular injection weekly

Intervention Type: DRUG

Castor Oil

intramuscular injection weekly

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain shams university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

ppprom

Identifier Type: -

Identifier Source: org_study_id