Planned Domiciliary Versus Hospital Care for Women With Preterm Prelabor Rupture of the Membranes (PPROM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Preterm Premature Rupture of Membrane
- Sponsor
- Ahmed Mohammed Selim
- Enrollment
- 3662
- Locations
- 1
- Primary Endpoint
- Take-home baby
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Ahmed Mohammed Selim
ASelim
Ain Shams Maternity Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •Query PPROM: A history of PPROM with no pooling of amniotic fluid from the cervix on a sterile speculum examination
- •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
Outcomes
Primary Outcomes
Take-home baby
Time Frame: 2 years
this outcome is the best indicator of success of the management plan when the outcome is alive \& well baby