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This study is designed 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.
Background: PPROM is encountered in 2.0% to 3.5% of pregnancies. Domiciliary care management is developing more and more in obstetrics, with psychological benefits for patients as well as other financial benefits. Reliable discharge criteria have been mentioned by few studies for patients with PPROM. Studies had shown that domiciliary care management in a context of PPROM did not modify perinatal morbidity and mortality, and allows a prolongation of the latency period. However, eligibility criteria for domiciliary care management were heterogeneous
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical follow up | Other | Patients recruited in this study commenced antibiotic treatment according to the recent guidelines :
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| Measure | Description | Time Frame |
|---|---|---|
| Take-home baby | this outcome is the best indicator of success of the management plan when the outcome is alive & well baby | 2 years |
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Inclusion Criteria include women with PPROM ≥28 weeks & <37 weeks with no signs of intra-amniotic infection & membranes rupture is confirmed by a sterile speculum examination and decrease amniotic fluid on ultrasound with singleton, viable, cephalic presenting fetus, morphologically normal fetus by ultrasound & reactive fetal heart rate tracing with no evidence of meconium-stained liquor
Exclusion Criteria:
pregnant women with rupture of the fetal membranes before 37 weeks of gestation
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The study will include 3662 women with a history of preterm prelabor rupture of the membranes
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine - Ain Shams university | Cairo | 11517 | Egypt |
all statistical methods, results of the study ,discussion & recommendations
onset of January, 2022 (6 months after publication)
sponsor e.mail & the sponsor organisation
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| ID | Term |
|---|---|
| C563032 | Preterm Premature Rupture of the Membranes |
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