Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management
Is Outpatient Management of PPROM Equivalent to Hospital Management
1 other identifier
interventional
560
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 25, 2015
CompletedFirst Posted
Study publicly available on registry
September 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 14, 2015
September 1, 2015
1.8 years
August 25, 2015
September 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
rate of occurence of Maternal morbidity
48 hours after delivery
Study Arms (2)
Home management
EXPERIMENTALoutpatient management patients if stable will be discharged to continue treatment at home
hospital management
ACTIVE COMPARATORInpatient management patients will continue there treatment in hospital till delivery
Interventions
patients if stable will be discharged to continue treatment at home
patients will continue there treatment in hospital till delivery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient with equivocal diagnosis of rupture of membranes
- advanced labor
- intrauterine infection
- vaginal bleeding or
- non reassuring fetal heart rate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ain Shams Maternity Hospitallead
- Ain Shams Universitycollaborator
Study Sites (1)
Ain Shams Maternity hospital
Cairo, Abbasya, 11821, Egypt
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Maged R Aboseda, professor
Ain Shams University maternity hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- specialist
Study Record Dates
First Submitted
August 25, 2015
First Posted
September 14, 2015
Study Start
August 1, 2014
Primary Completion
June 1, 2016
Study Completion
July 1, 2016
Last Updated
September 14, 2015
Record last verified: 2015-09