Clinical trial NCT00664118: Doula Combined Latent Phrase Epidural Analgesia in Primiparous Women
Official title: In Combination of Doula and Epidural Analgesia in the Latent Phrase of Labor in Primiparous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Doula
Patient-controlled epidural analgesia
Neuraxial analgesia
Labor analgesia
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2008-04-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of cesarean delivery
timeFrame: Analgesia initiation (0 h) to completion of vaginal delivery (4-7 h)
Secondary outcomes:
measure: Rate of instrumental delivery
timeFrame: Analgesia initiation (0 h) to successful vaginal delivery (4-7 h)
measure: Indications of cesarean delivery
timeFrame: Analgesia initiation (0 h) to cesarean section (4-7 h)
measure: Maternal Visual Analog Scale (VAS) rating of pain
timeFrame: 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
measure: Incidence of side effects
timeFrame: The whole period of the analgesia to successful vaginal delivery
measure: Low back pain at 3 months after vaginal delivery
timeFrame: Three months after vaginal delivery
measure: Maternal oral temperature
timeFrame: The whole period of the analgesia to successful vaginal delivery
measure: Use of oxytocin after analgesia
timeFrame: During the whole period of the analgesia
measure: Maximal oxytocin dose
timeFrame: 30 min after vaginal delivery
measure: Duration of analgesia
timeFrame: Initiation of analgesia (0h) to the disappearance of sensory block (4-8h)
measure: Breastfeeding success at 6 weeks after vaginal delivery
timeFrame: Six weeks after successful delivery
measure: Maternal satisfaction with analgesia
timeFrame: 30 min after the vaginal delivery
measure: Neonatal one-minute Apgar scale
timeFrame: One minute after baby was born
measure: Neonatal five-minute Apgar scale
timeFrame: Five minutes after baby was born
measure: Umbilical-cord gases analysis
timeFrame: Immediately after baby was born
measure: Neonatal sepsis evaluation
timeFrame: 5 min after the baby was born
measure: Neonatal antibiotic treatment
timeFrame: 5 min after the baby was born
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References: