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NCT01315860 · ClinicalTrials.gov registry record

Association of Biomechanical Changes and Weight Gain Throughout Pregnancy

A clinical trial, sponsored by Nova Southeastern University.

Completed
Registry status
28
Enrollment target

NCT01315860: Completed study, sponsored by Nova Southeastern University.

NCT01315860 is a clinical trial that has completed, run by Nova Southeastern University. The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01315860 has completed, sponsored by Nova Southeastern University.

COMPLETED
Registry status
28 participants
Enrollment target

Study Summary

Low back and posterior pelvic pain are common in pregnant females. Previous studies have demonstrated disability and it is estimated that all women experience some degree of musculoskeletal discomfort during pregnancy. Borg-Stein et. al. found 25% of pregnant females have temporarily disabling symptoms. There is demonstrated controversy over the mechanism of low back pain in pregnancy. The biomechanical theory implies that the enlarging uterus causes the maternal center of gravity to move anteriorly causing stress on the low back. Jensen et. al. demonstrated that weight gain correlated with biomechanical changes. The changes were measured by weight gain in segmental regions of the body and in principal moments of inertia from the sit to stand movement. Literature does not demonstrate a specific correlation between weight gain and the biomechanical changes of sway rate, lumbosacral angle and center of gravity. These three measurements may have a correlating effect on the underlying cause of low back pain in pregnant women. This study aims to determine the correlation between weight gain of pregnant females and the biomechanical changes of sway rate, lumbosacral angle and center of gravity. The change in weight over the last two trimesters will be correlated with the sway rate, lumbosacral angle and center of gravity. The degree of symptomatic low back pain as measured by the Oswestry Low Back Pain Scale will also be correlated with the sway rate, lumbosacral angle and center of gravity.

Primary Outcome

Amount of weight gain over the 2nd and 3rd trimester in lbs.

Interventions

  • OTHER Postural Analysis

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2011-03
Est. Completion 2012-06
Nova Southeastern University

71 total trials

What the finished NCT01315860 record still lists

NCT01315860 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which Postural Analysis is the first listed.

NCT01315860 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01315860 about?

NCT01315860 is a clinical study titled "Association of Biomechanical Changes and Weight Gain Throughout Pregnancy". Low back and posterior pelvic pain are common in pregnant females. Previous studies have demonstrated disability and it is estimated that all women experience some degree of musculoskeletal discomfort during pregnancy. Borg-Stein et. al. found 25% of pregnant females have temporarily disabling sympt...

What is the current status of trial NCT01315860?

This trial is currently completed. The enrollment target is 28 participants. The study started on 2011-03. Estimated completion is 2012-06.

What interventions are being tested in trial NCT01315860?

The interventions under investigation include: Postural Analysis (OTHER).

Who is sponsoring clinical trial NCT01315860?

This trial is sponsored by Nova Southeastern University, which has 71 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01315860, the US trial registry maintained by the National Library of Medicine. NCT01315860 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.