Epidural Analgesia in Different Cervix Diameter and the Rate of Cesarean Delivery (EACDRCD)

Nanjing Medical University

Status

Completed

Conditions

Labor Pain

Treatments

Procedure: Epidural labor analgesia

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00677274

NJFY-02028M03

NSR02970

Details and patient eligibility

About

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.

Enrollment

780 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

780 participants in 8 patient groups

Active Comparator group

Description:

Epidural analgesia initiated at the cervix 0cm

Treatment:

Procedure: Epidural labor analgesia

Active Comparator group

Description:

Epidural analgesia initiated at the cervix 0.5cm

Treatment:

Procedure: Epidural labor analgesia

Active Comparator group

Description:

Epidural analgesia initiated at the cervix 1.0cm

Treatment:

Procedure: Epidural labor analgesia

Active Comparator group

Description:

Epidural analgesia initiated at the cervix 1.5cm

Treatment:

Procedure: Epidural labor analgesia

Active Comparator group

Description:

Epidural analgesia initiated at the cervix 2.0cm

Treatment:

Procedure: Epidural labor analgesia

Active Comparator group

Description:

Epidural analgesia initiated at the cervix 3.0cm

Treatment:

Procedure: Epidural labor analgesia

Active Comparator group

Description:

Epidural analgesia initiated at the cervix 4.0cm

Treatment:

Procedure: Epidural labor analgesia

Active Comparator group

Description:

Epidural analgesia initiated at the cervix 5.0cm

Treatment:

Procedure: Epidural labor analgesia

Trial contacts and locations

Data sourced from clinicaltrials.gov

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