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

Primary Purpose

Preterm Premature Rupture of the Membranes, Physical Activity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moderate Activity
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Premature Rupture of the Membranes focused on measuring Preterm Premature Rupture of the Membranes, Bedrest, Physical Activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCSD Health Sciences, Labor & Delivery

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Bedrest

Moderate Activity

Arm Description

Bedrest is a standard recommendation for patients with PPROM. Subjects randomized to this arm of the study will undergo the following: Receive recommendation for bedrest (standard of care). Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure). Wear a pedometer to measure activity when out of bed (observational study procedure).

Subjects randomized to this arm of the study will undergo the following: 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). Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure). Wear a pedometer to measure activity when out of bed (observational study procedure).

Outcomes

Primary Outcome Measures

Change in Maternal Depression Score
Maternal Depression Score as measured by the Edinburg Postpartum Depression Scale will be determined at the time of enrollment and after delivery.

Secondary Outcome Measures

Change in Maternal Anxiety Score
Maternal Anxiety Score as measured by the State-Trait Anxiety Inventory will be determined at the time of enrollment and after delivery.
Change in Maternal Muscle Strength
Maternal Muscle Strength as measured by semi-quantitative muscle strength testinging will be determined at the time of enrollment and after delivery.

Full Information

First Posted
December 19, 2014
Last Updated
June 4, 2019
Sponsor
University of California, San Diego
Collaborators
University of California, San Francisco, University of California, Davis, University of California, Irvine, University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02327637
Brief Title
A Comparison of Bed Rest Versus Moderate Activity in Preterm Premature Rupture of Membranes (PPROM)
Acronym
PACT
Official Title
A Comparison of Bed Rest Versus Moderate Activity Among Inpatient Antepartum Patients With Preterm Premature Rupture of Membranes (PPROM): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 12, 2016 (Actual)
Study Completion Date
December 12, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
University of California, San Francisco, University of California, Davis, University of California, Irvine, University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Premature Rupture of the Membranes, Physical Activity
Keywords
Preterm Premature Rupture of the Membranes, Bedrest, Physical Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bedrest
Arm Type
No Intervention
Arm Description
Bedrest is a standard recommendation for patients with PPROM. Subjects randomized to this arm of the study will undergo the following: Receive recommendation for bedrest (standard of care). Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure). Wear a pedometer to measure activity when out of bed (observational study procedure).
Arm Title
Moderate Activity
Arm Type
Experimental
Arm Description
Subjects randomized to this arm of the study will undergo the following: 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). Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure). Wear a pedometer to measure activity when out of bed (observational study procedure).
Intervention Type
Behavioral
Intervention Name(s)
Moderate Activity
Intervention Description
Ambulation 150 feet, two times per day
Primary Outcome Measure Information:
Title
Change in Maternal Depression Score
Description
Maternal Depression Score as measured by the Edinburg Postpartum Depression Scale will be determined at the time of enrollment and after delivery.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary Outcome Measure Information:
Title
Change in Maternal Anxiety Score
Description
Maternal Anxiety Score as measured by the State-Trait Anxiety Inventory will be determined at the time of enrollment and after delivery.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Title
Change in Maternal Muscle Strength
Description
Maternal Muscle Strength as measured by semi-quantitative muscle strength testinging will be determined at the time of enrollment and after delivery.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise C Laurent, MD/PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Health Sciences, Labor & Delivery
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21508700
Citation
Waters TP, Mercer B. Preterm PROM: prediction, prevention, principles. Clin Obstet Gynecol. 2011 Jun;54(2):307-12. doi: 10.1097/GRF.0b013e318217d4d3.
Results Reference
background
PubMed Identifier
12517665
Citation
Mercer BM. Preterm premature rupture of the membranes. Obstet Gynecol. 2003 Jan;101(1):178-93. doi: 10.1016/s0029-7844(02)02366-9.
Results Reference
background
PubMed Identifier
2376856
Citation
Koonings PP, Paul RH, Campbell K. Umbilical cord prolapse. A contemporary look. J Reprod Med. 1990 Jul;35(7):690-2.
Results Reference
background
PubMed Identifier
19019329
Citation
Fox NS, Gelber SE, Kalish RB, Chasen ST. The recommendation for bed rest in the setting of arrested preterm labor and premature rupture of membranes. Am J Obstet Gynecol. 2009 Feb;200(2):165.e1-6. doi: 10.1016/j.ajog.2008.08.007. Epub 2008 Nov 18.
Results Reference
background
PubMed Identifier
932270
Citation
Kendall PC, Finch AJ Jr, Auerbach SM, Hooke JF, Mikulka PJ. The State-Trait Anxiety Inventory: a systematic evaluation. J Consult Clin Psychol. 1976 Jun;44(3):406-12. doi: 10.1037//0022-006x.44.3.406. No abstract available.
Results Reference
background

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

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