Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preterm Premature Rupture of Membranes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Home management

outpatient management patients if stable will be discharged to continue treatment at home

Group Type EXPERIMENTAL

outpatient management

Intervention Type OTHER

patients if stable will be discharged to continue treatment at home

hospital management

Inpatient management patients will continue there treatment in hospital till delivery

Group Type ACTIVE_COMPARATOR

Inpatient management

Intervention Type OTHER

patients will continue there treatment in hospital till delivery

Interventions

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outpatient management

patients if stable will be discharged to continue treatment at home

Intervention Type OTHER

Inpatient management

patients will continue there treatment in hospital till delivery

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No