PregnancyBRATNCT01544387
Preterm Premature Rupture of Membranes (PPROM): Bed Rest Versus Activity Trial
A study testing Bed Rest and Activity in people with Pregnancy and Pre-term Premature Rupture of Membranes, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Pregnancy, Pre-term Premature Rupture of Membranes
- What is being tested?
- Bed Rest and Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2010to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Multiple gestations
- Gestational age > 34 weeks
- Current treatment with MgSO4 for preterm labor
- Footling breech presentation
- Any maternal or fetal indication for immediate delivery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Elmhurst Hospital Center
Elmhurst, New York, 11373
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: 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).
Read the 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
- Being tested
- Bed Rest, Activity
- Keywords
- Preterm Premature Rupture Of Membranes, PPROM, Pregnancy, Bed rest.
- Medical subject headings
- Preterm Premature Rupture of the Membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bed RestOther
- 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
ActivityOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Bed Rest | Other | Subjects will have limited activity. Bed Rest Receives: Other: Bed Rest |
| Activity | Other | Activity Receives: Other: Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
AFI
primary outcome is the amniotic fluid index (AFI) - a 4 quadrant measurement of the amniotic fluid surrounding the fetus.
Measured: From admission to delivery, average 6-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJul 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanne Stone, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544387
- Sponsor's protocol ID
- GCO 10-0352
- Acronym
- BRAT
- Status last verified
- Feb 2014
- First submitted
- 23 Feb 2012
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26461925
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PPROM: Bed Rest Versus Activity Trial (BRAT)
- ClinicalTrials.gov ID
- NCT01544387
- Acronym / sponsor ID
- BRAT / GCO 10-0352
- Conditions
- Pregnancy, Pre-term Premature Rupture of Membranes
- Keywords
- Preterm Premature Rupture Of Membranes, PPROM, Pregnancy, Bed rest.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bed Rest | Other | Other: Bed RestSubjects will have limited activity. Bed Rest |
| Activity | Other | Other: ActivityActivity |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women
- Clinical diagnosis of PPROM (made by sterile speculum examination)
- Singleton pregnancy
- Vertex or frank breech presentation
- 18-55 years old
Key exclusion criteria (5 listed)
- Multiple gestations
- Gestational age > 34 weeks
- Current treatment with MgSO4 for preterm labor
- Footling breech presentation
- Any maternal or fetal indication for immediate delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Bed Rest |
| 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. | Other | Activity |
Primary outcome
AFI
Time frame: From admission to delivery, average 6-7 days
primary outcome is the amniotic fluid index (AFI) - a 4 quadrant measurement of the amniotic fluid surrounding the fetus.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
- Derived from this study: PubMed 26461925Bigelow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joanne Stone, MD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bed Rest and Activity in people with Pregnancy and Pre-term Premature Rupture of Membranes, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AFI (time frame: From admission to delivery, average 6-7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01544387, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.