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



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 55
Updated:5/27/2013
Start Date:July 2010
End Date:October 2013
Contact:Joanne Stone, MD
Email:joanne.stone@mssm.edu
Phone:212-241-9247

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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).


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.

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
We found this trial at
2
sites
1 Gustave L Levy Pl # 504
New York, New York 10029
 (212) 241-6500
Mount Sinai School of Medicine Icahn School of Medicine at Mount Sinai is proud to...
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