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

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).

Study Overview

• Status: Completed
• Conditions: Pregnancy; Pre-term Premature Rupture of Membranes
• Intervention / Treatment: Other: Bed Rest; Other: Activity

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Elmhurst, New York, United States, 11373
      • Elmhurst Hospital Center
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Bed Rest; Subjects will have limited activity. Bed Rest	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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Joanne Stone, MD, Icahn School of Medicine at Mount Sinai

Publications and helpful links

General Publications

• Bigelow CA, Factor SH, Miller M, Weintraub A, Stone J. Pilot Randomized Controlled Trial to Evaluate the Impact of Bed Rest on Maternal and Fetal Outcomes in Women with Preterm Premature Rupture of the Membranes. Am J Perinatol. 2016 Mar;33(4):356-63. doi: 10.1055/s-0035-1564427. Epub 2015 Oct 13.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 23, 2012
• First Submitted That Met QC Criteria: February 28, 2012
• First Posted (Estimate): March 5, 2012

Study Record Updates

• Last Update Posted (Estimate): February 28, 2014
• Last Update Submitted That Met QC Criteria: February 26, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Pregnancy; PPROM; Preterm Premature Rupture Of Membranes; Bed rest.
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture
• Other Study ID Numbers: GCO 10-0352