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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02327637
Other study ID # 140455
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 2014
Est. completion date December 12, 2016

Study information

Verified date December 2014
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date December 12, 2016
Est. primary completion date December 12, 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
Moderate Activity
Ambulation 150 feet, two times per day

Locations

Country Name City State
United States UCSD Health Sciences, Labor & Delivery San Diego California

Sponsors (5)

Lead Sponsor Collaborator
University of California, San Diego University of California, Davis, University of California, Irvine, University of California, Los Angeles, University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View Citation

Koonings PP, Paul RH, Campbell K. Umbilical cord prolapse. A contemporary look. J Reprod Med. 1990 Jul;35(7):690-2. — View Citation

Mercer BM. Preterm premature rupture of the membranes. Obstet Gynecol. 2003 Jan;101(1):178-93. Review. — View Citation

Waters TP, Mercer B. Preterm PROM: prediction, prevention, principles. Clin Obstet Gynecol. 2011 Jun;54(2):307-12. doi: 10.1097/GRF.0b013e318217d4d3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary 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. Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
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