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

• Conditions: Labor Analgesia

• Registration Number: NCT02708602
• Lead Sponsor: Nanjing Maternity and Child Health Care Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-18
• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Last Update Submitted: 2016-03-16
• Last Update Posted: 2016-03-17
• Primary Completion: 2016-04
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
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)
Maternal satisfaction with analgesia	At two hours postpartum	At two hours postpartum
Neonatal weight	At delivery	At delivery
Use of oxytocin after analgesia	At twenty-four hours postpartum	At twenty-four hours postpartum
Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture	At two hours postpartum	At two hours postpartum