Preterm Premature Rupture of Membranes (PPROM): Bed Rest Versus Activity Trial (BRAT)
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).
Pre-term Premature Rupture of Membranes
Other: Bed Rest
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||PPROM: Bed Rest Versus Activity Trial (BRAT)|
- AFI [ Time Frame: From admission to delivery, average 6-7 days ] [ Designated as safety issue: No ]primary outcome is the amniotic fluid index (AFI) - a 4 quadrant measurement of the amniotic fluid surrounding the fetus.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Subjects will have limited activity. Bed Rest
Other: Bed Rest
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.
|Contact: Joanne Stone, MDemail@example.com|
|Contact: Meredith Miller, MPHfirstname.lastname@example.org|
|United States, New York|
|Elmhurst Hospital Center||Recruiting|
|Elmhurst, New York, United States, 11373|
|Contact: Lauren Ferrara, MD 718-334-5366 email@example.com|
|Sub-Investigator: Lauren Ferrara, MD|
|Mount Sinai School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: Joanne Stone, MD|
|Contact: Meredith Miller, MPH|
|Principal Investigator: Joanne Stone, MD|
|Principal Investigator:||Joanne Stone, MD||Mount Sinai School of Medicine|