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Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management

Primary Purpose

Preterm Premature Rupture of Membranes

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
outpatient management
Inpatient management
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Premature Rupture of Membranes

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Ain Shams Maternity hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home management

hospital management

Arm Description

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

Inpatient management patients will continue there treatment in hospital till delivery

Outcomes

Primary Outcome Measures

rate occurence of Neonatal sepsis
proven neonatal infection with positive blood culture within 48 hours after birth, or culture proven neonatal pneumonia or meningitis

Secondary Outcome Measures

rate of occurence of Maternal morbidity
including chorioamnionitis , endometritis , septicaemia, admission to intensive care unit, organ failure, major postpartum hemorrhage

Full Information

First Posted
August 25, 2015
Last Updated
September 11, 2015
Sponsor
Ain Shams Maternity Hospital
Collaborators
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02548013
Brief Title
Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management
Official Title
Is Outpatient Management of PPROM Equivalent to Hospital Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital
Collaborators
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of Membranes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home management
Arm Type
Experimental
Arm Description
outpatient management patients if stable will be discharged to continue treatment at home
Arm Title
hospital management
Arm Type
Active Comparator
Arm Description
Inpatient management patients will continue there treatment in hospital till delivery
Intervention Type
Other
Intervention Name(s)
outpatient management
Intervention Description
patients if stable will be discharged to continue treatment at home
Intervention Type
Other
Intervention Name(s)
Inpatient management
Intervention Description
patients will continue there treatment in hospital till delivery
Primary Outcome Measure Information:
Title
rate occurence of Neonatal sepsis
Description
proven neonatal infection with positive blood culture within 48 hours after birth, or culture proven neonatal pneumonia or meningitis
Time Frame
48 hours after delivery
Secondary Outcome Measure Information:
Title
rate of occurence of Maternal morbidity
Description
including chorioamnionitis , endometritis , septicaemia, admission to intensive care unit, organ failure, major postpartum hemorrhage
Time Frame
48 hours after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina M Ibrahim
Phone
00201223603223
Email
Dr_dinamostafa@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad M Mamdouh
Phone
001227456554
Email
Ahmadreyad@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maged R Aboseda, professor
Organizational Affiliation
Ain Shams University maternity hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ain Shams Maternity hospital
City
Cairo
State/Province
Abbasya
ZIP/Postal Code
11821
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad m Mamdouh
Phone
00201227456554
Email
ahmadreyad@hotmail.com

12. IPD Sharing Statement

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Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management

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