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Low recruitment
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| University of California, Davis | OTHER |
| University of California, Irvine | OTHER |
| University of California, Los Angeles |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bedrest | No Intervention | Bedrest is a standard recommendation for patients with PPROM. Subjects randomized to this arm of the study will undergo the following:
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| Moderate Activity | Experimental | Subjects randomized to this arm of the study will undergo the following:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate Activity | Behavioral | Ambulation 150 feet, two times per day |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Change in Maternal Muscle Strength |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise C Laurent, MD/PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Health Sciences, Labor & Delivery | San Diego | California | 92103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21508700 | Background | Waters TP, Mercer B. Preterm PROM: prediction, prevention, principles. Clin Obstet Gynecol. 2011 Jun;54(2):307-12. doi: 10.1097/GRF.0b013e318217d4d3. | |
| 12517665 | Background | Mercer BM. Preterm premature rupture of the membranes. Obstet Gynecol. 2003 Jan;101(1):178-93. doi: 10.1016/s0029-7844(02)02366-9. |
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| ID | Term |
|---|---|
| C563032 | Preterm Premature Rupture of the Membranes |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| OTHER |
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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 |
| 2376856 | Background | Koonings PP, Paul RH, Campbell K. Umbilical cord prolapse. A contemporary look. J Reprod Med. 1990 Jul;35(7):690-2. |
| 19019329 | Background | 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. |
| 932270 | Background | 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. |