Correlation Between the Polymorphism ofβ2 AR and the Labor Progress After Labor Analgesia

• Sponsor: Nanjing Maternity and Child Health Care Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02708602
• Collaborator: (none)
• Enrollment: 300
• Duration (Months): 2

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Labor Analgesia	Genetic: β2AR polymorphism

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Principal Investigator
• Study Start Date: Mar 1, 2016
• Anticipated Primary Completion Date: Apr 1, 2016
• Anticipated Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
β2AR Arg16Arg (AA group) People with β2AR Arg16Arg genotype.	Genetic: β2AR polymorphism
β2AR Arg16Gly (AG group) People with β2AR Arg16Gly genotype.	Genetic: β2AR polymorphism
β2AR Gly16Gly (GG group) People with β2AR Gly16Gly genotype.	Genetic: β2AR polymorphism
β2AR Gln27Gln (CC group) People with β2AR Gln16Gln genotype.	Genetic: β2AR polymorphism
β2AR Gln27Glu (CG group) People with β2AR Gln27Glu genotype.	Genetic: β2AR polymorphism
β2AR Glu27Glu (GG group) People with β2AR Glu27Glu genotype.	Genetic: β2AR polymorphism

Outcome Measures

Primary Outcome Measures

1. total labor process [up to about 24h]

   time from the regular uterus contractions until completed childbirth, assessed up to about 24h

2. duration of the first stage [up to about 20h]

   time from the regular uterus contractions to full cervix dilation,assessed up to about 20h

3. duration of the second stage [up to about 2h]

   time from full cervix dilation to the complete childbirth, assessed up to about 2h

4. Maternal visual analogue scale [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)

Secondary Outcome Measures

1. method of delivery [At time of placental delivery]

   At time of placental delivery

2. Maternal modified Bromage scale [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)

3. Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture [At two hours postpartum]

   At two hours postpartum

4. Maternal satisfaction with analgesia [At two hours postpartum]

   At two hours postpartum

5. Use of oxytocin after analgesia [At twenty-four hours postpartum]

   At twenty-four hours postpartum

6. Neonatal Apgar scale [At the first and fifth minutes after baby was born]

   At the first and fifth minutes after baby was born

7. Maximal oxytocin dose [At twenty-four hours postpartum]

   At twenty-four hours postpartum

8. Maternal heart rate, respiratory rate, and blood pressure [At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)]

   At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)

9. Neonatal weight [At delivery]

   At delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 43 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Nulliparous women

• Required labor analgesia

• Chinese

• Spontaneous labor

Exclusion Criteria:

• 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

• Alcohol addictive or narcotic dependent patients

• Subjects with a nonvertex presentation or scheduled induction of labor

• Twin gestation and breech presentation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nanjing Maternity and Child Health Care Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Caijuan Li, Nanjing Maternity and Child Health Care Hospital, Nanjing Maternity and Child Health Care Hospital
• ClinicalTrials.gov Identifier: NCT02708602
• Other Study ID Numbers: NMCHC2016003
• First Posted: Mar 15, 2016
• Last Update Posted: Mar 17, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by Caijuan Li, Nanjing Maternity and Child Health Care Hospital, Nanjing Maternity and Child Health Care Hospital: β2-adrenergic receptor; genetic polymorphisms; labor progress

Study Results

No Results Posted as of Mar 17, 2016