Physical Activity, Preterm Premature Rupture of the Membranes
Conditions
Keywords
Preterm Premature Rupture of the Membranes, Bedrest, Physical Activity
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.
Interventions
BEHAVIORALModerate Activity
Ambulation 150 feet, two times per day
Sponsors
University of California, San Francisco
University of California, Davis
University of California, Irvine
University of California, Los Angeles
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed