Genetic and Demographic Factors That Influence the Pain and Progress of Labor

June 27, 2014 updated by: University of Virginia
The purpose of this study is to try to understand why the experience of labor differs among women. The investigators want to understand why some women have longer or shorter labors and why the amount of pain women experience is different. The investigators hope to be able to consider women more individually in terms of their pain and progress of labor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There is enormous variability among women in the progress of normal labor. Labor requires complex integrated interplay between the decidua, uterine cervix and myometrium that can take minutes, days or weeks to occur and is incompletely understood. Understanding the biological variables that underlie differences in labor progress has been hampered by the lack of appropriate models that allow sensitive statistical analysis. Identification of genetic and physiognomic factors that impact normal labor progress will allow for individualization of labor management and better use of societal resources.

Structural models of labor progress were first proposed by Friedman in the 1950s at Columbia University. Aspects of Friedman's model, such as the deceleration phase, have been debated since that time but Friedman's model allowed for identification and quantification of the latent and active phase of labor in populations. These concepts have been modified by the World Health Organization as the WHO Partogram, the use of which has resulted in reduced requirement of oxytocin and reduced incidence of cesarean section.

Dr. Flood's group has developed a continuous bi-exponential model of labor progress and sigmoidal model for labor pain that the investigators have statistically and experimentally validated in several independent databases. The investigators model can be used both prospectively in an individual labor and with large cohorts to identify variables that significantly affect the progress of labor.

The investigators have found in a previous work that parturients who carry G at the 27th amino acid beta-2 adrenergic receptors (β2AR) developed labor pain more rapidly that parturients with the common allele [1]. and the investigators also have found that catechol-O-methyltransferase (COMT) rs4633 genotype TT resulted in a slower latent phase rate, and oxytocin receptor rs53576 genotype GG transitioned to active labor earlier [2].

In this new project, the investigators are planning to use bigger data base, to detect further genes associations, and tested some pharmacogenetic variations that could explain the different response to same medications and doses among patients.

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
        • Sub-Investigator:
          • Abdullah S Terkawi, M.D.
        • Contact:
          • Abdullah S Terkawi, MD
      • Charlottesville, Virginia, United States, 22903
        • Not yet recruiting
        • University of Virginia
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Abdullah S Terkawi, M.D.
        • Principal Investigator:
          • Marcel E Durieux, M.D., Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant in active labor

Description

Inclusion Criteria:

  • Study participants will be women presenting in term labor.
  • Patients of all ethnicities will be included.
  • All subjects will be greater than or equal to 18 years of age and able to give consent.

Exclusion Criteria:

  • Include preexisting pain syndromes or the regular taking of pain medications.
  • Preterm birth (< 37 weeks) and preeclampsia.
  • Cervical dilatation more than 6 cm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Progress, Pain
Genetic: Progress, Pain
Progress, Pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Labor progress variability
Time Frame: We will monitor data from the entire period of labor, which may last from 1-30 hours
We will monitor data from the entire period of labor, which may last from 1-30 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Respond variability to different induction, augmentation and pain management medication Prostaglandine, Oxytocin, Epidural analgesia
Time Frame: admission to hospital discharge ( est. 2-3 days)
admission to hospital discharge ( est. 2-3 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Stanford University

Investigators

  • Principal Investigator: Abdullah S Terkawi, M.D., University of Virginia
  • Principal Investigator: Marcel E Durieux, M.D., Ph.D, University of Virginia
  • Principal Investigator: Pamela D Flood, M.D., Ph.D, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 27, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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