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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01544387
First received: February 23, 2012
Last updated: February 26, 2014
Last verified: February 2014

February 23, 2012
February 26, 2014
July 2010
January 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01544387 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Preterm Premature Rupture of Membranes (PPROM): Bed Rest Versus Activity Trial
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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Pregnancy
  • Pre-term Premature Rupture of Membranes
  • Other: Bed Rest
    • 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
  • Other: Activity
    • 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.
  • Bed Rest
    Subjects will have limited activity. Bed Rest
    Intervention: Other: Bed Rest
  • Activity
    Activity
    Intervention: Other: Activity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01544387
GCO 10-0352
No
Mount Sinai School of Medicine
Mount Sinai School of Medicine
Not Provided
Principal Investigator: Joanne Stone, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP