Status:
COMPLETED
Domiciliary Versus Hospital Management of PPROM
Lead Sponsor:
Ahmed Mohammed Selim
Conditions:
Preterm Premature Rupture of Membrane
Eligibility:
FEMALE
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 outcom...
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 financ...
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
Key Trial Info
Start Date :
April 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 20 2020
Estimated Enrollment :
3662 Patients enrolled
Trial Details
Trial ID
NCT04413019
Start Date
April 15 2019
End Date
October 20 2020
Last Update
January 6 2021
Active Locations (1)
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1
Faculty of medicine - Ain Shams university
Cairo, Egypt, 11517