Status:
COMPLETED
The Value of Amniopatch in Preterm Premature Rupture of Membranes
Lead Sponsor:
Cairo University
Conditions:
Preterm Premature Rupture of Membrane
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
A randomized controlled trial that involved 100 women diagnosed with PPROM between 24 and 34 weeks of gestational age. Participants were randomized equally into 2 groups. Group I in which amniopatch w...
Detailed Description
All patients were started on a regimen of hospital bed rest and received antibiotic prophylaxis consisting of ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours fo...
Eligibility Criteria
Inclusion
- healthy pregnant women
- gestational age of 24 to 34 weeks (calculated by the sure dates of the last menstrual period and confirmed by early 1st trimesteric ultrasound).
- All women carried a normal healthy singleton fetus
Exclusion
- established preterm labor at admission
- those with symptoms or signs suggestive of clinical chorioamnionitis.
- women with uncontrolled medical disorder e.g. severe hypertension, uncontrolled diabetes, chronic renal impairment
- women with vaginal bleeding regardless its cause.
- Pregnancies associated with major congenital fetal malformations
- placental insufficiency or anomalies
- anterior position of the placenta
- iatrogenic PPROM
Key Trial Info
Start Date :
October 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03473210
Start Date
October 1 2016
End Date
March 11 2018
Last Update
March 22 2018
Active Locations (1)
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1
Hany Hassan
Minya, Egypt