Effect of Progesterone on Latent Phase Prolongation in Patients With Preterm Premature Rupture of Membranes
- Conditions
- Preterm Premature Rupture of Membrane
- Interventions
- Registration Number
- NCT04807543
- Lead Sponsor
- Ain Shams University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- Singleton pregnancy
- Gestational age between 24 and 34 weeks
-
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description study group 17-hydroxyprogesterone caproate 17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection control group Castor Oil castor oil, 1 mL total volume intramuscular injection
- Primary Outcome Measures
Name Time Method prolongation of the pregnancy until a favorable gestational age 10 to 12 weeks (up to 34.0 weeks of gestation or documentation of fetal lung maturity at 32.0 to 33.9 weeks.) 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
- Secondary Outcome Measures
Name Time Method Composite neonatal morbidity 1 week (from delivery to 1 week post Natal) by Apgar score ,blood gases ,and labs
Latency . 10 to 12 weeks (interval in weeks from randomization to delivery) 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
Trial Locations
- Locations (1)
Ain shams university
🇪🇬Cairo, Egypt