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

Physical Activity Clinical Trial

— PACT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02327637
• Other study ID #: 140455
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Physical Activity
• Premature Birth
• Preterm Premature Rupture of the Membranes
• Rupture

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