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

Nanjing Medical University780 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

780

Conditions

Labor Pain

Interventions

Epidural labor analgesiaPROCEDURE

Epidural analgesia initiated at the onset of regular uterine contraction

Epidural labor analgesiaPROCEDURE

Epidural analgesia initiated at the cervix diameter 0.5cm

Epidural labor analgesiaPROCEDURE

Epidural analgesia initiated at the cervix diameter 1.0cm

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Nulliparous women 2. \> 18 years and \< 45 years 3. Spontaneous labor 4. Analgesia request Exclusion Criteria: 1. Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records 2. Participants younger than 18 years or older than 45 years 3. Those who were not willing to or could not finish the whole study at any time 4. Using or used in the past 14 days of the monoamine oxidase inhibitors 5. Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics; 6. Subjects with a nonvertex presentation or scheduled induction of labor 7. Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization. 8. Diagnosed diabetes mellitus and pregnancy-induced hypertension 9. Twin gestation and breech presentation.

Locations (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

Rate of cesarean delivery

Time frame: 10 min after successful vaginal delivery

Secondary Outcomes

Rate of instrument-assisted delivery

Time frame: 10 min after successful vaginal delivery

Indications of cesarean delivery

Time frame: 10 min after cesarean section

Maternal Visual Analog Scale (VAS) rating of pain

Time frame: 10 min prior to analgesia, at the cervix <4.0 cm, cervix 4.0-10.0 cm, cervix >10.0cm second stage of labor, 15min after vaginal delivery

Duration of analgesia

Time frame: 0 min after analgesia to 15min after the disappearance of sensory block

Maternal satisfaction with analgesia

Time frame: 30 min after the vaginal delivery

Maternal oral temperature

Time frame: 0, 15, 30, 60, 120, 240, 480min after analgesia

Use of oxytocin after analgesia

Time frame: 30 min after vaginal delivery

Maximal oxytocin dose

Time frame: 30 min after vaginal delivery

Low back pain at 3 months after vaginal delivery

Time frame: Three months after vaginal delivery

Breastfeeding success at 6 weeks after vaginal delivery

Data from ClinicalTrials.gov

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