Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management

Study Overview
=================
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.

Official Title
-----------------
Is Outpatient Management of PPROM Equivalent to Hospital Management

Conditions
-----------------
Preterm Premature Rupture of Membranes

Intervention / Treatment
-----------------
* Other: outpatient management
* Other: Inpatient management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PPROM with gestational age between 27 to 34 weeks Cephalic presentation Clear amniotic fluid Oral temperature > 38 C Near distance from the hospital (the patient can reach hospital within one hour ) Home environment safe and amenable to rest , availability of family support such as a sister or mother who will help the patient at home . Maternal and fetal condition remain stable after hospitalization for 72 hours Exclusion Criteria: Patient with equivocal diagnosis of rupture of membranes advanced labor intrauterine infection vaginal bleeding or non reassuring fetal heart rate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home management<br>outpatient management patients if stable will be discharged to continue treatment at home | Other: outpatient management<br>* patients if stable will be discharged to continue treatment at home<br>|
| Active Comparator: hospital management<br>Inpatient management patients will continue there treatment in hospital till delivery | Other: Inpatient management<br>* patients will continue there treatment in hospital till delivery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate occurence of Neonatal sepsis | proven neonatal infection with positive blood culture within 48 hours after birth, or culture proven neonatal pneumonia or meningitis | 48 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of occurence of Maternal morbidity | including chorioamnionitis , endometritis , septicaemia, admission to intensive care unit, organ failure, major postpartum hemorrhage | 48 hours after delivery |