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Clinical Trials/NCT02708602
NCT02708602UnknownNot Applicable

Principal Investigator

Nanjing Maternity and Child Health Care Hospital0 sites300 target enrollmentStarted: March 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
300
Primary Endpoint
total labor process

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
23 Years to 43 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

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

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)

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)

Investigators

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

Caijuan Li

Nanjing Maternity and Child Health Care Hospital

Nanjing Maternity and Child Health Care Hospital

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