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

NCT ID: NCT01544387

Last Updated: 2014-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-01-31

Brief 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.

Conditions

Pregnancy; Pre-term Premature Rupture of Membranes

Keywords

Preterm Premature Rupture Of Membranes; PPROM; Pregnancy; Bed rest.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Bed Rest

Subjects will have limited activity. Bed Rest

Group Type: OTHER

Bed Rest

Intervention Type: OTHER

• 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

Activity

Group Type: OTHER

Activity

Intervention Type: OTHER

• 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.

Interventions

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

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joanne Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Elmhurst Hospital Center

Elmhurst, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26461925 (View on PubMed)

Other Identifiers

GCO 10-0352

Identifier Type: -

Identifier Source: org_study_id