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

Labor Analgesia Clinical Trial

Official title:

Principal Investigator

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02708602
• Other study ID #: NMCHC2016003
• Status: Not yet recruiting
• Phase: N/A
• First received: February 18, 2016
• Last updated: March 16, 2016
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: March 2016
• Source: Nanjing Maternity and Child Health Care Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Nanjing Medical University
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 23 Years to 43 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Labor Analgesia

Intervention

Genetic:
• ß2AR polymorphism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Maternity and Child Health Care Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total labor process	time from the regular uterus contractions until completed childbirth, assessed up to about 24h	up to about 24h	No
Primary	duration of the first stage	time from the regular uterus contractions to full cervix dilation,assessed up to about 20h	up to about 20h	No
Primary	duration of the second stage	time from full cervix dilation to the complete childbirth, assessed up to about 2h	up to about 2h	No
Primary	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)	No
Secondary	method of delivery	At time of placental delivery	At time of placental delivery	No
Secondary	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)	No
Secondary	Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture	At two hours postpartum	At two hours postpartum	No
Secondary	Maternal satisfaction with analgesia	At two hours postpartum	At two hours postpartum	No
Secondary	Use of oxytocin after analgesia	At twenty-four hours postpartum	At twenty-four hours postpartum	No
Secondary	Neonatal Apgar scale	At the first and fifth minutes after baby was born	At the first and fifth minutes after baby was born	Yes
Secondary	Maximal oxytocin dose	At twenty-four hours postpartum	At twenty-four hours postpartum	Yes
Secondary	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)	Yes
Secondary	Neonatal weight	At delivery	At delivery	No