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Clinical Trials/NCT00677274
NCT00677274CompletedNot Applicable

Epidural Labor Analgesia in Different Cervical Dilation Diameter and the Risk of Cesarean Delivery

Nanjing Medical University1 site in 1 country780 target enrollmentStarted: May 1, 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
780
Locations
1
Primary Endpoint
Rate of cesarean delivery
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Epidural analgesia in the early stage of labor at cervix < 4.0cm was considered as a risk period for increasing the rate of cesarean delivery. The more recent studies and the investigators' previous data indicated epidural analgesia can be performed as early as the cervical dilation approximately 2.0cm. The investigators hypothesized that different cervix diameter had different rate of cesarean delivery. This trial would investigate the correlation amongst different cervical dilation and the risk of cesarean section in nulliparous women at term.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Nulliparous women
  • •> 18 years and < 45 years
  • •Spontaneous labor
  • •Analgesia request

Exclusion Criteria

  • •Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records
  • •Participants younger than 18 years or older than 45 years
  • •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 were excluded for their influence on the analgesic efficacy of the epidural analgesics;
  • •Subjects with a nonvertex presentation or scheduled induction of labor
  • •Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization.
  • •Diagnosed diabetes mellitus and pregnancy-induced hypertension
  • •Twin gestation and breech presentation.

Outcomes

Primary Outcomes

Rate of cesarean delivery

Time Frame: 10 min after successful vaginal delivery

Secondary Outcomes

  • Rate of instrument-assisted delivery(10 min after successful vaginal delivery)
  • Indications of cesarean delivery(10 min after cesarean section)
  • Maternal Visual Analog Scale (VAS) rating of pain(10 min prior to analgesia, at the cervix <4.0 cm, cervix 4.0-10.0 cm, cervix >10.0cm second stage of labor, 15min after vaginal delivery)
  • Duration of analgesia(0 min after analgesia to 15min after the disappearance of sensory block)
  • Maternal satisfaction with analgesia(30 min after the vaginal delivery)
  • Maternal oral temperature(0, 15, 30, 60, 120, 240, 480min after analgesia)
  • Use of oxytocin after analgesia(30 min after vaginal delivery)
  • Maximal oxytocin dose(30 min after vaginal delivery)
  • Low back pain at 3 months after vaginal delivery(Three months after vaginal delivery)
  • Breastfeeding success at 6 weeks after vaginal delivery(Six weeks after successful delivery)
  • Neonatal one-minute Apgar scale(1 min after baby was born)
  • Neonatal five-minute Apgar scale(Five min after baby was born)
  • Umbilical-cord gases analysis(0 min after baby was born)
  • Neonatal sepsis evaluation(30 min after baby was born)
  • Neonatal antibiotic treatment(1 week after baby was born)
  • Incidence of maternal side effects(1 week after successful vaginal delivery)

Investigators

Sponsor
Nanjing Medical University
Sponsor Class
Other

Study Sites (1)

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