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

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.

Study Overview

• Status: Unknown
• Conditions: Labor Analgesia
• Intervention / Treatment: Genetic: β2AR polymorphism

• Study Type: Observational
• Enrollment (Anticipated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
total labor process	time from the regular uterus contractions until completed childbirth, assessed up to about 24h	up to about 24h
duration of the first stage	time from the regular uterus contractions to full cervix dilation,assessed up to about 20h	up to about 20h
duration of the second stage	time from full cervix dilation to the complete childbirth, assessed up to about 2h	up to about 2h
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

Outcome Measure	Measure Description	Time Frame
method of delivery	At time of placental delivery	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)	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	At two hours postpartum
Maternal satisfaction with analgesia	At two hours postpartum	At two hours postpartum
Use of oxytocin after analgesia	At twenty-four hours postpartum	At twenty-four hours postpartum
Neonatal Apgar scale	At the first and fifth minutes after baby was born	At the first and fifth minutes after baby was born
Maximal oxytocin dose	At twenty-four hours postpartum	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)	At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
Neonatal weight	At delivery	At delivery

Collaborators and Investigators

• Sponsor: Nanjing Maternity and Child Health Care Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: March 9, 2016
• First Posted (Estimate): March 15, 2016

Study Record Updates

• Last Update Posted (Estimate): March 17, 2016
• Last Update Submitted That Met QC Criteria: March 16, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: genetic polymorphisms; β2-adrenergic receptor; labor progress
• Other Study ID Numbers: NMCHC2016003