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

Study Overview
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Brief Summary
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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
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After taking informed written consent, the recruited patients will be subjected to the following: 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. 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. 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.

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

Conditions
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Preterm Premature Rupture of Membrane

Intervention / Treatment
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* Drug: 17-hydroxyprogesterone caproate
* Drug: Castor Oil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group<br>17-hydroxyprogesterone caproate (17P) (250 mg in castor oil, 1 mL total volume)intramuscular injection | Drug: 17-hydroxyprogesterone caproate<br>* intramuscular injection weekly<br>|
| Placebo Comparator: control group<br>castor oil, 1 mL total volume intramuscular injection | Drug: Castor Oil<br>* intramuscular injection weekly<br>|

What is the study measuring?
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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) |