Labor AnalgesiaNCT02708602
Correlation Between the Polymorphism ofβ2 AR and the Labor Progress After Labor Analgesia
An observational study of Labor Analgesia, run by Nanjing Maternity and Child Health Care Hospital.
Trial summary
Labor and delivery is a unique physiological experience of women. Inappropriate length of labor progress during vaginal delivery may produce great risks for mother and fetus. Especially the slow progress is one of the most important reasons for the occurrence of cesarean section during vaginal delivery, which still… Read more about this study
- Who is it for?
- Ages 23 to 43 years, women only
- Conditions the study is for
- Labor Analgesia
- What is being tested?
- β2AR polymorphism
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 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 23 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: The parturient undergoing labor analgesia in our hospital. And the eligible parturient aged at 23-43, gestational age 35-42 weeks with an ASA grade I-II, who spontaneously choosing vaginal delivery mode with epidural analgesia.
Who may be able to join
- Nulliparous women
- Required labor analgesia
- Chinese
- Spontaneous labor
Who cannot join
- Contraindications for epidural analgesia
- Allergic to opioids and/or local anesthetics
- Failed to performing epidural catheterization
- Organic dysfunction
- Those who were not willing to or could not finish the whole study at any time
- Using or used in the past 14 days of the monoamine oxidase inhibitors
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- Alcohol addictive or narcotic dependent patients
- Subjects with a nonvertex presentation or scheduled induction of labor
- Twin gestation and breech presentation
About this study
Official title: Principal Investigator
Labor and delivery is a unique physiological experience of women. Inappropriate length of labor progress during vaginal delivery may produce great risks for mother and fetus. Especially the slow progress is one of the most important reasons for the occurrence of cesarean section during vaginal delivery, which still with a high incidence in recent years.Previous studies have found that there was a significant correlation between the genetic polymorphisms of β 2-adrenergic receptor (β2AR) and the duration of vaginal delivery.Therefore, the researchers intend to investigate the distribution of β2-adrenergic receptor (β2AR) genetic polymorphisms among Chinese parturient and observe the relationship between the genetic polymorphisms and labor process after labor analgesia.
- Conditions
- Labor Analgesia
- Being tested
- β2AR polymorphism
- Keywords
- β2-adrenergic receptor, genetic polymorphisms, labor progress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
β2AR polymorphismGenetic
| Study group | Role | What they receive |
|---|---|---|
| β2AR Arg16Arg (AA group) | People with β2AR Arg16Arg genotype. Receives: Genetic: β2AR polymorphism | |
| β2AR Arg16Gly (AG group) | People with β2AR Arg16Gly genotype. Receives: Genetic: β2AR polymorphism | |
| β2AR Gly16Gly (GG group) | People with β2AR Gly16Gly genotype. Receives: Genetic: β2AR polymorphism | |
| β2AR Gln27Gln (CC group) | People with β2AR Gln16Gln genotype. Receives: Genetic: β2AR polymorphism | |
| β2AR Gln27Glu (CG group) | People with β2AR Gln27Glu genotype. Receives: Genetic: β2AR polymorphism | |
| β2AR Glu27Glu (GG group) | People with β2AR Glu27Glu genotype. Receives: Genetic: β2AR polymorphism |
What is being measured
The primary outcome is the main question the study is designed to answer.
total labor process
time from the regular uterus contractions until completed childbirth, assessed up to about 24h
Measured: up to about 24h
duration of the first stage
time from the regular uterus contractions to full cervix dilation,assessed up to about 20h
Measured: up to about 20h
duration of the second stage
time from full cervix dilation to the complete childbirth, assessed up to about 2h
Measured: up to about 2h
Maternal visual analogue scale
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Measured: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Secondary outcomes (9)
method of delivery
At time of placental delivery
Measured: At time of placental delivery
Maternal modified Bromage scale
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Measured: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture
At two hours postpartum
Measured: At two hours postpartum
Maternal satisfaction with analgesia
At two hours postpartum
Measured: At two hours postpartum
Use of oxytocin after analgesia
At twenty-four hours postpartum
Measured: At twenty-four hours postpartum
Neonatal Apgar scale
At the first and fifth minutes after baby was born
Measured: At the first and fifth minutes after baby was born
Maximal oxytocin dose
At twenty-four hours postpartum
Measured: At twenty-four hours postpartum
Maternal heart rate, respiratory rate, and blood pressure
At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Measured: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Neonatal weight
At delivery
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor AnalgesiaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Maternity and Child Health Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caijuan Li, Nanjing Maternity and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708602
- Sponsor's protocol ID
- NMCHC2016003
- Status last verified
- Mar 2016
- First submitted
- 18 Feb 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT02708602
- Acronym / sponsor ID
- NMCHC2016003
- Conditions
- Labor Analgesia
- Keywords
- β2-adrenergic receptor, genetic polymorphisms, labor progress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nanjing Maternity and Child Health Care HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 15 Mar 2016 (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.
Labor and delivery is a unique physiological experience of women. Inappropriate length of labor progress during vaginal delivery may produce great risks for mother and fetus. Especially the slow progress is one of the most important reasons for the occurrence of cesarean section during vaginal delivery, which still with a high incidence in recent years.Previous studies have found that there was a significant correlation between the genetic polymorphisms of β 2-adrenergic receptor (β2AR) and the duration of vaginal delivery.Therefore, the researchers intend to investigate the distribution of β2-adrenergic receptor (β2AR) genetic polymorphisms among Chinese parturient and observe the relationship between the genetic polymorphisms and labor process after labor analgesia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| β2AR Arg16Arg (AA group) | – | Genetic: β2AR polymorphismPeople with β2AR Arg16Arg genotype. |
| β2AR Arg16Gly (AG group) | – | Genetic: β2AR polymorphismPeople with β2AR Arg16Gly genotype. |
| β2AR Gly16Gly (GG group) | – | Genetic: β2AR polymorphismPeople with β2AR Gly16Gly genotype. |
| β2AR Gln27Gln (CC group) | – | Genetic: β2AR polymorphismPeople with β2AR Gln16Gln genotype. |
| β2AR Gln27Glu (CG group) | – | Genetic: β2AR polymorphismPeople with β2AR Gln27Glu genotype. |
| β2AR Glu27Glu (GG group) | – | Genetic: β2AR polymorphismPeople with β2AR Glu27Glu genotype. |
Who may qualify
- Ages
- 23 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The parturient undergoing labor analgesia in our hospital. And the eligible parturient aged at 23-43, gestational age 35-42 weeks with an ASA grade I-II, who spontaneously choosing vaginal delivery mode with epidural analgesia.
Key inclusion criteria (4 listed)
- Nulliparous women
- Required labor analgesia
- Chinese
- Spontaneous labor
Key exclusion criteria (9 listed)
- Contraindications for epidural analgesia
- Allergic to opioids and/or local anesthetics
- Failed to performing epidural catheterization
- Organic dysfunction
- Those who were not willing to or could not finish the whole study at any time
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 |
|---|---|---|
| β2AR polymorphism | Genetic | β2AR Arg16Arg (AA group), β2AR Arg16Gly (AG group), β2AR Gln27Gln (CC group), β2AR Gln27Glu (CG group), β2AR Glu27Glu (GG group), β2AR Gly16Gly (GG group) |
Primary outcome
total labor process
Time frame: up to about 24h
time from the regular uterus contractions until completed childbirth, assessed up to about 24h
duration of the first stage
Time frame: up to about 20h
time from the regular uterus contractions to full cervix dilation,assessed up to about 20h
duration of the second stage
Time frame: up to about 2h
time from full cervix dilation to the complete childbirth, assessed up to about 2h
Maternal visual analogue scale
Time frame: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
9 secondary outcomes
method of delivery
Time frame: At time of placental delivery
Maternal modified Bromage scale
Time frame: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture
Time frame: At two hours postpartum
Maternal satisfaction with analgesia
Time frame: At two hours postpartum
Use of oxytocin after analgesia
Time frame: At twenty-four hours postpartum
Neonatal Apgar scale
Time frame: At the first and fifth minutes after baby was born
Maximal oxytocin dose
Time frame: At twenty-four hours postpartum
Maternal heart rate, respiratory rate, and blood pressure
Time frame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Neonatal weight
Time frame: At delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Analgesia, run by Nanjing Maternity and Child Health Care Hospital.
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 4 inclusion and 9 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 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total labor process (time frame: up to about 24h). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2016; AzTrials last refreshed its copy on 3 Nov 2026.