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

Not Applicable

Terminated

• Conditions: Preterm Premature Rupture of the Membranes; Physical Activity
• Interventions: Behavioral: Moderate Activity

• Registration Number: NCT02327637
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Status Verified: 2014-12
• Study Start: 2014-12
• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-30
• Primary Completion: 2016-12-12
• Study Completion: 2016-12-12
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Moderate Activity	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).

Primary Outcome Measures

Name	Time	Method
Change in Maternal Depression Score	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.

Secondary Outcome Measures

Name	Time	Method
Change in Maternal Muscle Strength	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.
Change in Maternal Anxiety Score	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.

Trial Locations

Locations (1)

UCSD Health Sciences, Labor & Delivery; 🇺🇸 San Diego, California, United States