Clinical trial NCT02708602: Correlation Between the Polymorphism ofβ2 AR and the Labor Progress After Labor Analgesia
Official title: Principal Investigator
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Labor Analgesia
Keywords: β2-adrenergic receptor
genetic polymorphisms
labor progress
Lead sponsor: Nanjing Maternity and Child Health Care Hospital
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: total labor process
timeFrame: up to about 24h
measure: duration of the first stage
timeFrame: up to about 20h
measure: duration of the second stage
timeFrame: up to about 2h
measure: Maternal visual analogue scale
timeFrame: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
Secondary outcomes:
measure: method of delivery
timeFrame: At time of placental delivery
measure: Maternal modified Bromage scale
timeFrame: At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)
measure: Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture
timeFrame: At two hours postpartum
measure: Maternal satisfaction with analgesia
timeFrame: At two hours postpartum
measure: Use of oxytocin after analgesia
timeFrame: At twenty-four hours postpartum
measure: Neonatal Apgar scale
timeFrame: At the first and fifth minutes after baby was born
measure: Maximal oxytocin dose
timeFrame: At twenty-four hours postpartum
measure: Maternal heart rate, respiratory rate, and blood pressure
timeFrame: At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
measure: Neonatal weight
timeFrame: At delivery
Other outcomes:
Locations:
Study officials:
References: