Preterm Premature Rupture of Membranes (PPROM): Bed Rest Versus Activity Trial

NCT01544387 | Completed

• 1 other identifier: GCO 10-0352
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this study is to determine, through a randomized clinical trial, whether bed rest is helpful for the management of pregnancies complicated by preterm premature rupture of membranes (PPROM).

Conditions

Pregnancy; Pre-term Premature Rupture of Membranes

Keywords

Preterm Premature Rupture Of Membranes; PPROM; Pregnancy; Bed rest.

Outcome Measures

Primary Outcomes (1)

• AFI

  primary outcome is the amniotic fluid index (AFI) - a 4 quadrant measurement of the amniotic fluid surrounding the fetus.

  From admission to delivery, average 6-7 days

Study Arms (2)

Bed Rest

OTHER

Subjects will have limited activity. Bed Rest

Other: Bed Rest

Activity

OTHER

Activity

Other: Activity

Interventions

Bed Rest OTHER

* Subjects are admitted to their labor and delivery room and will spend the majority of their day in their hospital bed, usually in a reclined or sleeping position * Subjects will be instructed to refrain from walking or engaging in any extraneous activity, including lifting or spending any extended period of time out of bed * Subjects may have limited bathroom privileges

Bed Rest

Activity OTHER

* Subjects are admitted to their labor and delivery room and will spend the majority of their time in their hospital bed * Subjects will be given the opportunity of 3 periods of walking around their room and/or the hall on labor and delivery each day, each period consisting of approximately 20 minutes - this is the minimum activity level required for the study. Subjects are permitted more activity as desired.

Activity

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women
• Clinical diagnosis of PPROM (made by sterile speculum examination)
• Singleton pregnancy
• Vertex or frank breech presentation
• years old
• Gestational age \< 34 weeks

You may not qualify if:

• Multiple gestations
• Gestational age \> 34 weeks
• Current treatment with MgSO4 for preterm labor
• Footling breech presentation
• Any maternal or fetal indication for immediate delivery

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Elmhurst Hospital Center

Elmhurst, New York, 11373, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Bigelow CA, Factor SH, Miller M, Weintraub A, Stone J. Pilot Randomized Controlled Trial to Evaluate the Impact of Bed Rest on Maternal and Fetal Outcomes in Women with Preterm Premature Rupture of the Membranes. Am J Perinatol. 2016 Mar;33(4):356-63. doi: 10.1055/s-0035-1564427. Epub 2015 Oct 13.

  PMID: 26461925 DERIVED

MeSH Terms

Conditions

Preterm Premature Rupture of the Membranes

Interventions

Bed Rest; Exercise

Intervention Hierarchy (Ancestors)

Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joanne Stone, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2012
• First Posted: March 5, 2012
• Study Start: July 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

US (2)