Rapid Progress of LaborNCT02178878
Genetic and Demographic Factors That Influence the Pain and Progress of Labor
An observational study of Rapid Progress of Labor, run by University of Virginia at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rapid Progress of Labor
- What is being tested?
- Progress, Pain
- How many people
- 800 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant in active labor
Who may be able to join
- 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.
Who cannot join
- Include preexisting pain syndromes or the regular taking of pain medications.
- Preterm birth (< 37 weeks) and preeclampsia.
- Cervical dilatation more than 6 cm
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Not yet recruiting
University of Virginia
Charlottesville, Virginia, 22903
Abdullah S Terkawi, M.D., 434-242-3145, asterkawi@virginia.edu
Marcia Birk, meb2w@virginia.edu
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Abdullah S Terkawi, MD
Abdullah S Terkawi, M.D.
About this study
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.
Read the 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.
- Conditions
- Rapid Progress of Labor
- Being tested
- Progress, Pain
- Keywords
- Labor pain and progress, variation, genetic
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progress, PainGenetic
Progress, Pain
| Study group | Role | What they receive |
|---|---|---|
| Progress, Pain | Progress, Pain Receives: Genetic: Progress, Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Labor progress variability
Measured: We will monitor data from the entire period of labor, which may last from 1-30 hours
Secondary outcomes (1)
Respond variability to different induction, augmentation and pain management medication Prostaglandine, Oxytocin, Epidural analgesia
Measured: admission to hospital discharge ( est. 2-3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rapid Progress of LaborStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Abdullah S Terkawi, M.D., Principal investigator, University of VirginiaMarcel E Durieux, M.D., Ph.D, Principal investigator, University of VirginiaPamela D Flood, M.D., Ph.D, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178878
- Sponsor's protocol ID
- 17054
- Status last verified
- Jun 2014
- First submitted
- 30 Apr 2014
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Terkawi AS, Jackson WM, Thiet MP, Hansoti S, Tabassum R, Flood P. Oxytocin and catechol-O-methyltransferase receptor genotype predict the length of the first stage of labor. Am J Obstet Gynecol. 2012 Sep;207(3):184.e1-8. doi: 10.1016/j.ajog.2012.06.079. Epub 2012 Jul 10.
PubMed 22939719Terkawi AS, Jackson WM, Hansoti S, Tabassum R, Flood P. Polymorphism in the ADRB2 gene explains a small portion of intersubject variability in pain relative to cervical dilation in the first stage of labor. Anesthesiology. 2014 Jul;121(1):140-8. doi: 10.1097/ALN.0000000000000258.
PubMed 24714117
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Demographic Factors That Influence the Pain and Progress of Labor
- ClinicalTrials.gov ID
- NCT02178878
- Acronym / sponsor ID
- 17054
- Conditions
- Rapid Progress of Labor
- Keywords
- Labor pain and progress, variation, genetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Stanford University
- Study start
- May 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Progress, Pain | – | Genetic: Progress, PainProgress, Pain |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant in active labor
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Include preexisting pain syndromes or the regular taking of pain medications.
- Preterm birth (< 37 weeks) and preeclampsia.
- Cervical dilatation more than 6 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progress, PainProgress, Pain | Genetic | Progress, Pain |
Primary outcome
Labor progress variability
Time frame: We will monitor data from the entire period of labor, which may last from 1-30 hours
1 secondary outcome
Respond variability to different induction, augmentation and pain management medication Prostaglandine, Oxytocin, Epidural analgesia
Time frame: admission to hospital discharge ( est. 2-3 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2014.
- Background: PubMed 22939719Terkawi AS, Jackson WM, Thiet MP, Hansoti S, Tabassum R, Flood P. Oxytocin and catechol-O-methyltransferase receptor genotype predict the length of the first stage of labor. Am J Obstet Gynecol. 2012 Sep;207(3):184.e1-8. doi: 10.1016/j.ajog.2012.06.079. Epub 2012 Jul 10.
- Background: PubMed 24714117Terkawi AS, Jackson WM, Hansoti S, Tabassum R, Flood P. Polymorphism in the ADRB2 gene explains a small portion of intersubject variability in pain relative to cervical dilation in the first stage of labor. Anesthesiology. 2014 Jul;121(1):140-8. doi: 10.1097/ALN.0000000000000258.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdullah S Terkawi, M.D. principal investigator
University of Virginia
Marcel E Durieux, M.D., Ph.D principal investigator
University of Virginia
Pamela D Flood, M.D., Ph.D principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rapid Progress of Labor, run by University of Virginia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcia Birk (434-982-0230, meb2w@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Labor progress variability (time frame: We will monitor data from the entire period of labor, which may last from 1-30 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02178878, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2014.