Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management

September 11, 2015 updated by: dina mostafa ibrahim, Ain Shams Maternity Hospital

Is Outpatient Management of PPROM Equivalent to Hospital Management

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

560

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Abbasya
      • Cairo, Abbasya, Egypt, 11821
        • Recruiting
        • Ain Shams Maternity Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Home management
outpatient management patients if stable will be discharged to continue treatment at home
Other: outpatient management
patients if stable will be discharged to continue treatment at home
Active Comparator: hospital management
Inpatient management patients will continue there treatment in hospital till delivery
Other: Inpatient management
patients will continue there treatment in hospital till delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate occurence of Neonatal sepsis
Time Frame: 48 hours after delivery
proven neonatal infection with positive blood culture within 48 hours after birth, or culture proven neonatal pneumonia or meningitis
48 hours after delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams Maternity Hospital

Collaborators

Ain Shams University

Investigators

  • Study Chair: Maged R Aboseda, professor, Ain shams university maternity hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Estimate)

September 14, 2015

Last Update Submitted That Met QC Criteria

September 11, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ain Shams MS PPROM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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