NCT04413019

Domiciliary Versus Hospital Management of PPROM

Planned Domiciliary Versus Hospital Care for Women With Preterm Prelabor Rupture of the Membranes (PPROM)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,662 (actual)
• Sponsor: Ahmed Mohammed Selim · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Preterm Premature Rupture of Membrane

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2019-04-15
• Primary completion: 2020-10-01
• Completion: 2020-10-20
• First posted: 2020-06-02
• Last updated: 2021-01-06

Locations

1 site across 1 country: Egypt