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Completed

NCT Number: NCT00664118

Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women

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.

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doula combined analgesia

Procedure

Doula combined epidural analgesia in the latent phase of first stage of labor in primiparas

Analgesia without doula

Procedure

Epidural analgesia in the latent phase of first stage of labor without doula accompany in primiparas

Primary outcomes

  1. Rate of cesarean delivery

    Time frame: Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)

Secondary outcomes

  1. Rate of instrumental delivery

    Time frame: Analgesia initiation (0 h) to successful vaginal delivery (4-7 h)

  2. Indications of cesarean delivery

    Time frame: Analgesia initiation (0 h) to cesarean section (4-7 h)

  3. Maternal Visual Analog Scale (VAS) rating of pain

    Time frame: 15 min prior to analgesia, 0-3 h of the latent phrase, 2-3 h of the active phrase, 1-2 h of the second stage of labor, 15 min posterior to delivery

  4. Incidence of side effects

    Time frame: The whole period of the analgesia to successful vaginal delivery

  5. Low back pain at 3 months after vaginal delivery

    Time frame: Three months after vaginal delivery

  6. Maternal oral temperature

    Time frame: The whole period of the analgesia to successful vaginal delivery

  7. Use of oxytocin after analgesia

    Time frame: During the whole period of the analgesia

  8. Maximal oxytocin dose

    Time frame: 30 min after vaginal delivery

  9. Duration of analgesia

    Time frame: Initiation of analgesia (0h) to the disappearance of sensory block (4-8h)

  10. Breastfeeding success at 6 weeks after vaginal delivery

    Time frame: Six weeks after successful delivery

  11. Maternal satisfaction with analgesia

    Time frame: 30 min after the vaginal delivery

  12. Neonatal one-minute Apgar scale

    Time frame: One minute after baby was born

  13. Neonatal five-minute Apgar scale

    Time frame: Five minutes after baby was born

  14. Umbilical-cord gases analysis

    Time frame: Immediately after baby was born

  15. Neonatal sepsis evaluation

    Time frame: 5 min after the baby was born

  16. Neonatal antibiotic treatment

    Time frame: 5 min after the baby was born

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

In Combination of Doula and Epidural Analgesia in the Latent Phrase of Labor in Primiparous Women

Acronym: DCLEAP

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2008
Registry last updated
May 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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