Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management

Is Outpatient Management of PPROM Equivalent to Hospital Management

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02548013

Enrollment

560

Registered

2015-09-14

Start date

2014-08-31

Completion date

2016-07-31

Last updated

2015-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Premature Rupture of Membranes

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.

Interventions

OTHERoutpatient management

patients if stable will be discharged to continue treatment at home

OTHERInpatient management

patients will continue there treatment in hospital till delivery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Egypt

Contacts

Primary ContactDina M Ibrahim

Dr_dinamostafa@hotmail.com00201223603223

Backup ContactAhmad M Mamdouh

Ahmadreyad@hotmail.com001227456554

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026