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Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women (DCLEAP)

N

Nanjing Medical University

Status

Completed

Conditions

Labor Pain

Treatments

Procedure: Doula combined analgesia
Procedure: Analgesia without doula

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00664118
NMUC-08022
NMCHCH-0121-236

Details and patient eligibility

About

Accumulating evidence indicated that neuraxial analgesia in the latent phase of the first stage of labor would be an effective and safe health care procedure for nulliparas. Doulas, women with labor experience trained for parturients, is a new way to alleviate the psychological stress from the laboring pain. Previous data in our study showed that doula accompany is a good method in shortening the progress of labor used in the active phrase of the first stage of labor, and decreasing the rate of cesarean delivery. Investigators hypothesized that doula combined neuraxial (epidural) analgesia in the latent phrase would be a superior means for effective pain relief, decreased rate of cesarean section, and shortened duration of labor.

Enrollment

500 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 4.0 cm or greater before performing epidural puncture and catheterization

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

500 participants in 2 patient groups

1
Active Comparator group
Description:
Doula combined epidural analgesia in the latent phase of first stage of labor
Treatment:
Procedure: Doula combined analgesia
2
Sham Comparator group
Description:
Epidural analgesia in the latent phase of the first stage of labor without doula accompany
Treatment:
Procedure: Analgesia without doula

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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