NCT02708602

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

1 month

First QC Date

February 18, 2016

Last Update Submit

March 16, 2016

Conditions

Labor Analgesia

Keywords

β2-adrenergic receptorgenetic polymorphismslabor progress

Outcome Measures

Primary Outcomes (4)

  • total labor process

    time from the regular uterus contractions until completed childbirth, assessed up to about 24h

    up to about 24h

  • duration of the first stage

    time from the regular uterus contractions to full cervix dilation,assessed up to about 20h

    up to about 20h

  • duration of the second stage

    time from full cervix dilation to the complete childbirth, assessed up to about 2h

    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)

Secondary Outcomes (9)

  • 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

  • Maternal satisfaction with analgesia

    At two hours postpartum

  • Use of oxytocin after analgesia

    At twenty-four hours postpartum

  • +4 more secondary outcomes

Study Arms (6)

β2AR Arg16Arg (AA group)

People with β2AR Arg16Arg genotype.

Genetic: β2AR polymorphism

β2AR Arg16Gly (AG group)

People with β2AR Arg16Gly genotype.

Genetic: β2AR polymorphism

β2AR Gly16Gly (GG group)

People with β2AR Gly16Gly genotype.

Genetic: β2AR polymorphism

β2AR Gln27Gln (CC group)

People with β2AR Gln16Gln genotype.

Genetic: β2AR polymorphism

β2AR Gln27Glu (CG group)

People with β2AR Gln27Glu genotype.

Genetic: β2AR polymorphism

β2AR Glu27Glu (GG group)

People with β2AR Glu27Glu genotype.

Genetic: β2AR polymorphism

Interventions

β2AR polymorphismGENETIC
β2AR Arg16Arg (AA group)β2AR Arg16Gly (AG group)β2AR Gln27Gln (CC group)β2AR Gln27Glu (CG group)β2AR Glu27Glu (GG group)β2AR Gly16Gly (GG group)

Eligibility Criteria

Age23 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • Nulliparous women
  • Required labor analgesia
  • Chinese
  • Spontaneous labor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nanjing Maternity and Child Health Care Hospital

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 15, 2016

Study Start

March 1, 2016

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

March 17, 2016

Record last verified: 2016-03