A Comparison of Bed Rest Versus Moderate Activity in Preterm Premature Rupture of Membranes (PPROM) (PACT)

June 4, 2019 updated by: Louise Laurent, MD/PhD, University of California, San Diego

A Comparison of Bed Rest Versus Moderate Activity Among Inpatient Antepartum Patients With Preterm Premature Rupture of Membranes (PPROM): A Randomized Controlled Trial

Bed rest has been a commonly prescribed intervention for high risk pregnancies, despite the lack of data to support its benefits, and increasing evidence pointing to potential harms. In this study, the effects of bed rest compared to moderate activity will be on maternal mood and muscle strength will be evaluated in patients with preterm premature rupture of membranes (PPROM).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Historically, bed rest has been considered a beneficial treatment option for patients with high risk pregnancies. The definition of bed rest varies between providers, and can mean anything from being completely bed-bound for months at a time (sometimes called strict bed rest) to walking around within the home a few times a day (sometimes called modified bed rest). Recent studies have highlighted potential harmful effects from bed rest. However, scientific studies need to be carried out to compare the effects of bed rest and moderate activity on the health of mothers and babies.

PPROM is defined as rupture of membranes prior to 37 weeks gestation prior to the onset of labor, and affects approximately 3% of all pregnancies in the Unites States. Women with PPROM are routinely managed in the inpatient setting from the time of diagnosis until delivery. Therefore, PPROM patients are a closely supervised and easily accessible cohort of women.

In this study, participating patients with PPROM will be randomized into two groups: bedrest or moderate activity. Maternal mood and muscle strength will be assessed at enrollment and after delivery to determine whether there are significant differences in these outcomes in the two groups.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD Health Sciences, Labor & Delivery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant
  • Gestational age between 23 weeks 0 days - 32 weeks 0 days
  • Diagnosed with preterm premature rupture of membranes

Exclusion Criteria:

  • Cervical dilation greater than or equal to 3cm
  • Active labor
  • Evidence of infection
  • Inability to provide informed consent
  • Requirement for continuous fetal monitoring

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Bedrest

Bedrest is a standard recommendation for patients with PPROM. Subjects randomized to this arm of the study will undergo the following:

  1. Receive recommendation for bedrest (standard of care).
  2. Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure).
  3. Wear a pedometer to measure activity when out of bed (observational study procedure).
Experimental: Moderate Activity

Subjects randomized to this arm of the study will undergo the following:

  1. Receive recommendation to ambulate 150 feet, twice per day (interventional study procedure). Prior to each session of ambulation, an ultrasound will be performed to ensure adequate amniotic fluid volume and appropriate fetal position, and a fetal heart rate tracing will be obtained to ensure that there is reassuring fetal status (observational study procedure). During each session of ambulation, the fetal heart rate tracing will be monitored continuously (observational study procedure).
  2. Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure).
  3. Wear a pedometer to measure activity when out of bed (observational study procedure).
Behavioral: Moderate Activity
Ambulation 150 feet, two times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maternal Depression Score
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Maternal Depression Score as measured by the Edinburg Postpartum Depression Scale will be determined at the time of enrollment and after delivery.
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maternal Anxiety Score
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Maternal Anxiety Score as measured by the State-Trait Anxiety Inventory will be determined at the time of enrollment and after delivery.
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Change in Maternal Muscle Strength
Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Maternal Muscle Strength as measured by semi-quantitative muscle strength testinging will be determined at the time of enrollment and after delivery.
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

University of California, Los Angeles
University of California, Davis
University of California, San Francisco
University of California, Irvine

Investigators

  • Principal Investigator: Louise C Laurent, MD/PhD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 12, 2016

Study Completion (Actual)

December 12, 2016

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 23, 2014

First Posted (Estimate)

December 30, 2014

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140455

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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