NCT00677274

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
780

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

3 months

First QC Date

May 12, 2008

Last Update Submit

February 11, 2009

Conditions

Labor Pain

Keywords

Epidural analgesiaPatient-controlled analgesia

Outcome Measures

Primary Outcomes (1)

  • Rate of cesarean delivery

    10 min after successful vaginal delivery

Secondary Outcomes (16)

  • 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

  • +11 more secondary outcomes

Study Arms (8)

1

ACTIVE COMPARATOR

Epidural analgesia initiated at the cervix 0cm

Procedure: Epidural labor analgesia

2

ACTIVE COMPARATOR

Epidural analgesia initiated at the cervix 0.5cm

Procedure: Epidural labor analgesia

3

ACTIVE COMPARATOR

Epidural analgesia initiated at the cervix 1.0cm

Procedure: Epidural labor analgesia

4

ACTIVE COMPARATOR

Epidural analgesia initiated at the cervix 1.5cm

Procedure: Epidural labor analgesia

5

ACTIVE COMPARATOR

Epidural analgesia initiated at the cervix 2.0cm

Procedure: Epidural labor analgesia

6

ACTIVE COMPARATOR

Epidural analgesia initiated at the cervix 3.0cm

Procedure: Epidural labor analgesia

7

ACTIVE COMPARATOR

Epidural analgesia initiated at the cervix 4.0cm

Procedure: Epidural labor analgesia

8

ACTIVE COMPARATOR

Epidural analgesia initiated at the cervix 5.0cm

Procedure: Epidural labor analgesia

Interventions

Epidural labor analgesiaPROCEDURE

Epidural analgesia initiated at the onset of regular uterine contraction

Also known as: Peridural analgesia
1

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

May 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

CN(1)