Clinical trial NCT02327637: A Comparison of Bed Rest Versus Moderate Activity in Preterm Premature Rupture of Membranes (PPROM)
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
Overall status: TERMINATED
Phase: NA
Conditions: Preterm Premature Rupture of the Membranes
Physical Activity
Keywords: Preterm Premature Rupture of the Membranes
Bedrest
Physical Activity
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: University of California, Davis
name: University of California, Irvine
name: University of California, Los Angeles
First posted: 2014-12-30
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in Maternal Depression Score
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes:
measure: Change in Maternal Anxiety Score
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: Change in Maternal Muscle Strength
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Health Sciences, Labor & Delivery
state: California
Study officials:
affiliation: University of California, San Diego
name: Louise C Laurent, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Waters TP, Mercer B. Preterm PROM: prediction, prevention, principles. Clin Obstet Gynecol. 2011 Jun;54(2):307-12. doi: 10.1097/GRF.0b013e318217d4d3.
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.
citation: Koonings PP, Paul RH, Campbell K. Umbilical cord prolapse. A contemporary look. J Reprod Med. 1990 Jul;35(7):690-2.
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.
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.