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Clinical Trials/NCT02708602
NCT02708602
Unknown
Not Applicable

Principal Investigator

Nanjing Maternity and Child Health Care Hospital0 sites300 target enrollmentMarch 2016
ConditionsLabor Analgesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Labor Analgesia
Sponsor
Nanjing Maternity and Child Health Care Hospital
Enrollment
300
Primary Endpoint
duration of the second stage
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
May 2016
Last Updated
10 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Nanjing Maternity and Child Health Care Hospital
Responsible Party
Principal Investigator
Principal Investigator

Caijuan Li

Nanjing Maternity and Child Health Care Hospital

Nanjing Maternity and Child Health Care Hospital

Eligibility Criteria

Inclusion Criteria

  • Nulliparous women
  • Required labor analgesia
  • 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

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

  • method of 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))
  • Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture(At two hours postpartum)
  • Use of oxytocin after analgesia(At twenty-four hours postpartum)
  • Neonatal Apgar scale(At the first and fifth minutes after baby was born)
  • Maximal oxytocin dose(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))
  • Maternal satisfaction with analgesia(At two hours postpartum)
  • Neonatal weight(At delivery)

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