Preterm Premature Rupture of Membrane
Conditions
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.
Interventions
intramuscular injection weekly
DRUGCastor Oil
intramuscular injection weekly
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Composite neonatal morbidity | 1 week (from delivery to 1 week post Natal) | by Apgar score ,blood gases ,and labs |
Countries
Egypt
Outcome results
None listed