Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women

Nanjing Medical University500 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

500

Conditions

Labor Pain

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of cesarean delivery

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

Secondary Outcomes

Rate of instrumental delivery

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

Indications of cesarean delivery

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

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

Incidence of side effects

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

Low back pain at 3 months after vaginal delivery

Time frame: Three months after vaginal delivery

Maternal oral temperature

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

Use of oxytocin after analgesia

Time frame: During the whole period of the analgesia

Maximal oxytocin dose

Time frame: 30 min after vaginal delivery

Duration of analgesia

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

Breastfeeding success at 6 weeks after vaginal delivery

Time frame: Six weeks after successful delivery

Maternal satisfaction with analgesia

Time frame: 30 min after the vaginal delivery

Neonatal one-minute Apgar scale

Time frame: One minute after baby was born

Neonatal five-minute Apgar scale

Time frame: Five minutes after baby was born

Umbilical-cord gases analysis

Time frame: Immediately after baby was born

Neonatal sepsis evaluation

Time frame: 5 min after the baby was born

Neonatal antibiotic treatment