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

NCT01544387 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-02-28

No results posted yet for this study

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

Interventions

OTHER

Bed Rest

* 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

OTHER

Activity

* 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.

Sponsors & Collaborators

Principal Investigators

  • Joanne Stone, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01544387 on ClinicalTrials.gov