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Preterm Premature Rupture of Membranes (PPROM): Bed Rest Versus Activity Trial (BRAT)

Primary Purpose

Pregnancy, Pre-term Premature Rupture of Membranes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bed Rest
Activity
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy focused on measuring Preterm Premature Rupture Of Membranes, PPROM, Pregnancy, Bed rest.

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Inclusion Criteria
  • Pregnant women
  • Clinical diagnosis of PPROM (made by sterile speculum examination)
  • Singleton pregnancy
  • Vertex or frank breech presentation
  • 18-55 years old
  • Gestational age < 34 weeks

Exclusion Criteria:

  • Multiple gestations
  • Gestational age > 34 weeks
  • Current treatment with MgSO4 for preterm labor
  • Footling breech presentation
  • Any maternal or fetal indication for immediate delivery

Sites / Locations

  • Elmhurst Hospital Center
  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Bed Rest

Activity

Arm Description

Subjects will have limited activity. Bed Rest

Activity

Outcomes

Primary Outcome Measures

AFI
primary outcome is the amniotic fluid index (AFI) - a 4 quadrant measurement of the amniotic fluid surrounding the fetus.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2012
Last Updated
February 26, 2014
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT01544387
Brief Title
Preterm Premature Rupture of Membranes (PPROM): Bed Rest Versus Activity Trial
Acronym
BRAT
Official Title
PPROM: Bed Rest Versus Activity Trial (BRAT)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to determine, through a randomized clinical trial, whether bed rest is helpful for the management of pregnancies complicated by preterm premature rupture of membranes (PPROM).
Detailed Description
Bed rest at home or in the hospital has been widely advised for many complications of pregnancy, including preterm premature rupture of membranes (PPROM) - a problem in which the water breaks prematurely and is not accompanied by labor. For most patients, bed rest represents a significant change in lifestyle, including having to stop work, and/or not being able to do household duties or take care of their children. In pregnancies, complicated by PPROM, patients are usually hospitalized and placed on bed rest throughout the stay. Despite its widespread use, there are no good published studies evaluating the effect of bed rest on common complications of pregnancy. There are, on the other hand, several other studies that indicate that bed rest may actually be harmful. Bed rest has been shown to increase a patient's risk for developing blood clots in their legs or in their lungs. Bed rest may also have myriad other deleterious effects such as muscle and bone atrophy. Furthermore, bed rest has been shown to be emotionally distressing both to the patient and her family. Once the amniotic membranes are broken, amniotic fluid will generally continue to leak for the remainder of the pregnancy, and a fetus in otherwise good health will continue to make more amniotic fluid by urination. In patients hospitalized with PPROM, an objective assessment that can be obtained is an ultrasound amniotic fluid index (AFI), which measures how much amniotic fluid remains despite the water having broken. It is thought that a greater amount of amniotic fluid may be indicative of a longer duration/continuation of pregnancy and fewer adverse interim effects such as cord compression. Remaining on bed rest was thought to perhaps affect the AFI in a positive way. It is unclear whether retaining the ability to ambulate would affect the AFI, because amniotic fluid continues to leak even while on bed rest; the benefits of ambulation may be well worthwhile. Twice weekly ultrasound amniotic fluid measurement will be checked to assess the effects of ambulation verses bed rest in pregnancies complicated by PPROM, and secondarily look at the overall outcome of the pregnancy. The objective of this study is to determine, through a randomized clinical trial, whether bed rest is helpful for the management of pregnancies complicated by preterm premature rupture of membranes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Pre-term Premature Rupture of Membranes
Keywords
Preterm Premature Rupture Of Membranes, PPROM, Pregnancy, Bed rest.

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Bed Rest
Arm Type
Other
Arm Description
Subjects will have limited activity. Bed Rest
Arm Title
Activity
Arm Type
Other
Arm Description
Activity
Intervention Type
Other
Intervention Name(s)
Bed Rest
Intervention Description
Subjects are admitted to their labor and delivery room and will spend the majority of their day in their hospital bed, usually in a reclined or sleeping position Subjects will be instructed to refrain from walking or engaging in any extraneous activity, including lifting or spending any extended period of time out of bed Subjects may have limited bathroom privileges
Intervention Type
Other
Intervention Name(s)
Activity
Intervention Description
Subjects are admitted to their labor and delivery room and will spend the majority of their time in their hospital bed Subjects will be given the opportunity of 3 periods of walking around their room and/or the hall on labor and delivery each day, each period consisting of approximately 20 minutes - this is the minimum activity level required for the study. Subjects are permitted more activity as desired.
Primary Outcome Measure Information:
Title
AFI
Description
primary outcome is the amniotic fluid index (AFI) - a 4 quadrant measurement of the amniotic fluid surrounding the fetus.
Time Frame
From admission to delivery, average 6-7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria Pregnant women Clinical diagnosis of PPROM (made by sterile speculum examination) Singleton pregnancy Vertex or frank breech presentation 18-55 years old Gestational age < 34 weeks Exclusion Criteria: Multiple gestations Gestational age > 34 weeks Current treatment with MgSO4 for preterm labor Footling breech presentation Any maternal or fetal indication for immediate delivery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Stone, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elmhurst Hospital Center
City
Elmhurst
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26461925
Citation
Bigelow CA, Factor SH, Miller M, Weintraub A, Stone J. Pilot Randomized Controlled Trial to Evaluate the Impact of Bed Rest on Maternal and Fetal Outcomes in Women with Preterm Premature Rupture of the Membranes. Am J Perinatol. 2016 Mar;33(4):356-63. doi: 10.1055/s-0035-1564427. Epub 2015 Oct 13.
Results Reference
derived

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Preterm Premature Rupture of Membranes (PPROM): Bed Rest Versus Activity Trial

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