Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3662 participants
OBSERVATIONAL
2019-04-15
2020-10-20
Brief Summary
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Detailed Description
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Aim of The Work: The aim of this study is to compare efficacy \& safety of planned domiciliary versus hospital care for women with preterm prelabor rupture of the membranes (PPROM) on fetal, neonatal and maternal outcome.
Patients \& Methods: The current trial was conducted at Ain Shams University Maternity Hospital. A total of 3662 pregnant women were recruited from the outpatient clinic \& emergency room and included in the study. Then, they were randomized into two groups; group (D) was counseled for home care management, while group (H) was hospitalized. Take-home baby was assessed as a primary outcome and other maternal, fetal \& neonatal complications were recorded \& moreover latency period, mode of delivery \& preference of care were assessed
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group (D): Planned domiciliary care.
Patients within this group will be counseled for home care with self-monitoring for any symptoms suggestive of preterm labor, maternal or fetal distress.
Clinical follow up
Patients recruited in this study commenced antibiotic treatment according to the recent guidelines :
* Erythromycin 250 mg 4 times daily for 10 days following the diagnosis of PPROM, or until the women is established labor (whichever sooner)
* Penicillin may be used in patients who can't tolerate erythromycin
* In cases of penicillin allergy: Cefazolin 1 g intravenously every 8 hours for 48 hours, followed by cephalexin 500 mg orally four times daily for five days. These drugs provide coverage for both GBS and Escherichia coli, the two major causes of neonatal infection.
Group (H): Planned hospital care.
Patients within this group will be admitted at hospital for close monitoring of maternal \& fetal wellbeing \& finally the neonatal outcome
Clinical follow up
Patients recruited in this study commenced antibiotic treatment according to the recent guidelines :
* Erythromycin 250 mg 4 times daily for 10 days following the diagnosis of PPROM, or until the women is established labor (whichever sooner)
* Penicillin may be used in patients who can't tolerate erythromycin
* In cases of penicillin allergy: Cefazolin 1 g intravenously every 8 hours for 48 hours, followed by cephalexin 500 mg orally four times daily for five days. These drugs provide coverage for both GBS and Escherichia coli, the two major causes of neonatal infection.
Interventions
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Clinical follow up
Patients recruited in this study commenced antibiotic treatment according to the recent guidelines :
* Erythromycin 250 mg 4 times daily for 10 days following the diagnosis of PPROM, or until the women is established labor (whichever sooner)
* Penicillin may be used in patients who can't tolerate erythromycin
* In cases of penicillin allergy: Cefazolin 1 g intravenously every 8 hours for 48 hours, followed by cephalexin 500 mg orally four times daily for five days. These drugs provide coverage for both GBS and Escherichia coli, the two major causes of neonatal infection.
Eligibility Criteria
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Exclusion Criteria
* Maternal comorbidities (Diabetes mellitus, hypertension, etc.)
* Patients with placenta previa
* Amniotic fluid pocket on ultrasound \< 2x2 cm
* Logistic problems interfering with follow-up
* Inability to check temperature every six hours, with parameters for notifying their clinician (temperature ≥38°C)
* Non-Dependable transportation
FEMALE
No
Sponsors
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Ahmed Mohammed Selim
OTHER
Responsible Party
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Ahmed Mohammed Selim
ASelim
Locations
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Faculty of medicine - Ain Shams university
Cairo, , Egypt
Countries
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Other Identifiers
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PPROM
Identifier Type: -
Identifier Source: org_study_id
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