PainNCT00385294
Role of B2 Adrenergic Receptors in Labor Pain
An observational study of Pain and Pain Threshold, run by Columbia University at 1 site in United States.
Trial summary
The study aims to understand why labor is more painful for some women compared to others. The study will study whether a woman's baseline pain sensitivity, beta2 adrenergic receptor genotype is related to her pain in labor for the birth of a first child. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pain, Pain Threshold, Labour Pain
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jan 2009
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Nuliparous women anticipating NSVD
Who may be able to join
- nulliparous women
- Third trimester of pregnancy on enrollment
Who cannot join
- Chronic Pain
- Pain medication utilization
- Large for gestational age baby
- Small for gestational age baby
- Systemic illness
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to understand why labor is more painful for some women compared to others. The study will study whether a woman's baseline pain sensitivity, beta2 adrenergic receptor genotype is related to her pain in labor for the birth of a first child.
Read the detailed description
Other than parity, and infant size, the etiology of the great variability in labor pain us unknown. Previous studies have demonstrated that baseline pain sensitivity is related to postoperative pain and narcotic requirement. We hypothesize that baseline pain sensitivity is related to pain in labor. The study will determine baseline sensitivity to heat, cold and pressure as measurement of pain sensitivity. Furthermore, b2 adrenergic genotype has recently been identified as a potential determinant of pain sensitivity. The investigators will determine whether B2 receptor haplotype is an independent predictor of pain experienced in labor.
- Conditions
- Pain, Pain Threshold, Labour Pain
- Keywords
- Genetic, pain, obstetrical
- Medical subject headings
- Pain, Labor Pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionJan 2009
- Study completionJan 2009
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 PainStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pamela Flood, Columbia University
- Investigators
- Pamela D. Flood, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385294
- Sponsor's protocol ID
- AAAB3535
- Status last verified
- Jul 2018
- First submitted
- 5 Oct 2006
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liang DY, Liao G, Wang J, Usuka J, Guo Y, Peltz G, Clark JD. A genetic analysis of opioid-induced hyperalgesia in mice. Anesthesiology. 2006 May;104(5):1054-62. doi: 10.1097/00000542-200605000-00023.
PubMed 16645459Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8. doi: 10.1097/00000542-200509000-00026.
PubMed 16129988
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of B2 Adrenergic Receptors in Labor Pain
- ClinicalTrials.gov ID
- NCT00385294
- Acronym / sponsor ID
- AAAB3535
- Conditions
- Pain, Pain Threshold, Labour Pain
- Keywords
- Genetic, pain, obstetrical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 9 Oct 2006 (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 study aims to understand why labor is more painful for some women compared to others. The study will study whether a woman's baseline pain sensitivity, beta2 adrenergic receptor genotype is related to her pain in labor for the birth of a first child.
Detailed description
Other than parity, and infant size, the etiology of the great variability in labor pain us unknown. Previous studies have demonstrated that baseline pain sensitivity is related to postoperative pain and narcotic requirement. We hypothesize that baseline pain sensitivity is related to pain in labor. The study will determine baseline sensitivity to heat, cold and pressure as measurement of pain sensitivity. Furthermore, b2 adrenergic genotype has recently been identified as a potential determinant of pain sensitivity. The investigators will determine whether B2 receptor haplotype is an independent predictor of pain experienced in labor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Nuliparous women anticipating NSVD
Key inclusion criteria (2 listed)
- nulliparous women
- Third trimester of pregnancy on enrollment
Key exclusion criteria (5 listed)
- Chronic Pain
- Pain medication utilization
- Large for gestational age baby
- Small for gestational age baby
- Systemic illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Background: PubMed 16645459Liang DY, Liao G, Wang J, Usuka J, Guo Y, Peltz G, Clark JD. A genetic analysis of opioid-induced hyperalgesia in mice. Anesthesiology. 2006 May;104(5):1054-62. doi: 10.1097/00000542-200605000-00023.
- Background: PubMed 16129988Hsu YW, Somma J, Hung YC, Tsai PS, Yang CH, Chen CC. Predicting postoperative pain by preoperative pressure pain assessment. Anesthesiology. 2005 Sep;103(3):613-8. doi: 10.1097/00000542-200509000-00026.
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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.
Pamela D. Flood, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Pain Threshold, run by Columbia University at 1 site 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00385294, 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 18 Jul 2018.