Preterm Premature Rupture of Membranes (PPROM): Bed Rest Versus Activity Trial
Condition: Pregnancy; Pre-term Premature Rupture of Membranes
MeSH terms: Premature Birth; Fetal Membranes, Premature Rupture; Rupture
Study type: Interventional

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.
    

Intervention name(s): Bed Rest; Activity
Intervention type(s): Other; Other
Intervention description(s): 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; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Preterm Premature Rupture Of Membranes; PPROM; Pregnancy; Bed rest.