Preterm Premature Rupture of Membranes (PPROM): Bed Rest Versus Activity Trial (BRAT)
|ClinicalTrials.gov Identifier: NCT01544387|
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : February 28, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Pre-term Premature Rupture of Membranes||Other: Bed Rest Other: Activity||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||PPROM: Bed Rest Versus Activity Trial (BRAT)|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Subjects will have limited activity. Bed Rest
Other: Bed Rest
- AFI [ Time Frame: From admission to delivery, average 6-7 days ]primary outcome is the amniotic fluid index (AFI) - a 4 quadrant measurement of the amniotic fluid surrounding the fetus.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544387
|United States, New York|
|Elmhurst Hospital Center|
|Elmhurst, New York, United States, 11373|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Joanne Stone, MD||Icahn School of Medicine at Mount Sinai|