Preterm Premature Rupture of Membranes, Outpatient Management vs Inpatient Management

Preterm Premature Rupture of Membranes Clinical Trial

Official title:

Is Outpatient Management of PPROM Equivalent to Hospital Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02548013
• Other study ID #: Ain Shams MS PPROM
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2015
• Last updated: September 11, 2015
• Start date: August 2014
• Est. completion date: July 2016

Study information

• Verified date: September 2015
• Source: Ain Shams Maternity Hospital
• Contact: Dina M Ibrahim
• Phone: 00201223603223
• Email: Dr_dinamostafa[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Birth
• Preterm Premature Rupture of Membranes
• Rupture

Intervention

Other:
• outpatient management
patients if stable will be discharged to continue treatment at home
• Inpatient management
patients will continue there treatment in hospital till delivery

Locations

Country	Name	City	State
Egypt	Ain Shams Maternity hospital	Cairo	Abbasya

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

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