Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management

Ain Shams Maternity Hospital

Status: Unknown

Conditions: Preterm Premature Rupture of Membranes

Treatments: Other: Inpatient management; Other: outpatient management

Study type: Interventional

Funder types: Other

Identifiers

NCT02548013

Ain Shams MS PPROM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 560 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 2 patient groups

Home management

Experimental group

Description:

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

Treatment:

Other: outpatient management

hospital management

Active Comparator group

Description:

Inpatient management patients will continue there treatment in hospital till delivery

Treatment:

Other: Inpatient management