NCT04807543

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	17-hydroxyprogesterone caproate	intramuscular injection weekly
DRUG	Castor Oil	intramuscular injection weekly

Timeline

• Start date: 2018-01-10
• Primary completion: 2020-10-10
• Completion: 2020-12-10
• First posted: 2021-03-19
• Last updated: 2021-03-19

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study