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

Pregnancy Clinical Trial

— BRAT  

Official title:

PPROM: Bed Rest Versus Activity Trial (BRAT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01544387
• Other study ID #: GCO 10-0352
• Status: Completed
• Phase: N/A
• First received: February 23, 2012
• Last updated: February 26, 2014
• Start date: July 2010
• Est. completion date: January 2013

Study information

• Verified date: February 2014
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Pre-term Premature Rupture of Membranes
• Pregnancy
• Premature Birth
• Rupture

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Elmhurst Hospital Center	Elmhurst	New York
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AFI	primary outcome is the amniotic fluid index (AFI) - a 4 quadrant measurement of the amniotic fluid surrounding the fetus.	From admission to delivery, average 6-7 days	No