Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management

Not Applicable

• Conditions: Preterm Premature Rupture of Membranes
• Interventions: Other: outpatient management; Other: Inpatient management

• Registration Number: NCT02548013
• Lead Sponsor: Ain Shams Maternity Hospital

Brief Summary

This study is to compare the maternal and neonatal outcomes in the patients with PPROM who are managed at home versus those managed at hospital, half the patients will be managed at home and the other half will be managed inpatient.

Detailed Description

Now the current practice is to manage patients with PPROM at hospital, however it is not known yet whether this practice is better than outpatient management as regard maternal and neonatal outcome.

There is some recent evidence that home management of PPROM is safe for both mother and neonate, home management is also more convenient with less expenses.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-08-25
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-11
• Last Update Submitted: 2015-09-11
• Study First Posted: 2015-09-14
• Last Update Posted: 2015-09-14
• Primary Completion: 2016-06
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 560

Inclusion Criteria

1. PPROM with gestational age between 27 to 34 weeks
2. Cephalic presentation
3. Clear amniotic fluid
4. Oral temperature > 38 C
5. Near distance from the hospital (the patient can reach hospital within one hour )
6. Home environment safe and amenable to rest , availability of family support such as a sister or mother who will help the patient at home .
7. Maternal and fetal condition remain stable after hospitalization for 72 hours

Exclusion Criteria

1. Patient with equivocal diagnosis of rupture of membranes
2. advanced labor
3. intrauterine infection
4. vaginal bleeding or
5. non reassuring fetal heart rate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home management	outpatient management	outpatient management patients if stable will be discharged to continue treatment at home
hospital management	Inpatient management	Inpatient management patients will continue there treatment in hospital till delivery

Primary Outcome Measures

Name	Time	Method
rate occurence of Neonatal sepsis	48 hours after delivery	proven neonatal infection with positive blood culture within 48 hours after birth, or culture proven neonatal pneumonia or meningitis

Secondary Outcome Measures

Name	Time	Method
rate of occurence of Maternal morbidity	48 hours after delivery	including chorioamnionitis , endometritis , septicaemia, admission to intensive care unit, organ failure, major postpartum hemorrhage

Trial Locations

Locations (1)

Ain Shams Maternity hospital; 🇪🇬 Cairo, Abbasya, Egypt