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

NCT02327637 | Terminated DMC

• 1 other identifier: 140455
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Preterm Premature Rupture of the Membranes; Physical Activity

Keywords

Preterm Premature Rupture of the Membranes; Bedrest; Physical Activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Maternal Anxiety Score

  Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

• Change in Maternal Muscle Strength

  Participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

Bedrest

NO INTERVENTION

Bedrest is a standard recommendation for patients with PPROM. Subjects randomized to this arm of the study will undergo the following: 1. Receive recommendation for bedrest (standard of care). 2. Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure). 3. Wear a pedometer to measure activity when out of bed (observational study procedure).

Moderate Activity

EXPERIMENTAL

Subjects randomized to this arm of the study will undergo the following: 1. Receive recommendation to ambulate 150 feet, twice per day (interventional study procedure). Prior to each session of ambulation, an ultrasound will be performed to ensure adequate amniotic fluid volume and appropriate fetal position, and a fetal heart rate tracing will be obtained to ensure that there is reassuring fetal status (observational study procedure). During each session of ambulation, the fetal heart rate tracing will be monitored continuously (observational study procedure). 2. Have maternal mood and muscle strength evaluated on enrollment and after delivery (observational study procedure). 3. Wear a pedometer to measure activity when out of bed (observational study procedure).

Behavioral: Moderate Activity

Interventions

Moderate Activity BEHAVIORAL

Ambulation 150 feet, two times per day

Moderate Activity

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant
• Gestational age between 23 weeks 0 days - 32 weeks 0 days
• Diagnosed with preterm premature rupture of membranes

You may not qualify if:

• Cervical dilation greater than or equal to 3cm
• Active labor
• Evidence of infection
• Inability to provide informed consent
• Requirement for continuous fetal monitoring

Sponsors & Collaborators

• University of California, San Diego: lead
• University of California, San Francisco: collaborator
• University of California, Davis: collaborator
• University of California, Irvine: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

UCSD Health Sciences, Labor & Delivery

San Diego, California, 92103, United States

Location

Related Publications (5)

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

  PMID: 21508700 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.

  PMID: 12517665 BACKGROUND

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

  PMID: 2376856 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.

  PMID: 19019329 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.

  PMID: 932270 BACKGROUND

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Louise C Laurent, MD/PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 30, 2014
• Study Start: December 1, 2014
• Primary Completion: December 12, 2016
• Study Completion: December 12, 2016
• Last Updated: June 6, 2019

Record last verified: 2014-12

Locations

US (1)