Domiciliary Versus Hospital Management of PPROM

Completed

• Conditions: Preterm Premature Rupture of Membrane
• Interventions: Other: Clinical follow up

• Registration Number: NCT04413019
• Lead Sponsor: Ahmed Mohammed Selim

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

Study Timeline

• Study Start: 2019-04-15
• Study First Submitted: 2020-05-29
• Study First Submitted QC: 2020-06-01
• Study First Posted: 2020-06-02
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3662

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group (D): Planned domiciliary care.	Clinical follow up	Patients within this group will be counseled for home care with self-monitoring for any symptoms suggestive of preterm labor, maternal or fetal distress.
Group (H): Planned hospital care.	Clinical follow up	Patients within this group will be admitted at hospital for close monitoring of maternal \& fetal wellbeing \& finally the neonatal outcome

Primary Outcome Measures

Name	Time	Method
Take-home baby	2 years	this outcome is the best indicator of success of the management plan when the outcome is alive \& well baby

Trial Locations

Locations (1)

Faculty of medicine - Ain Shams university; 🇪🇬 Cairo, Egypt