Comparison of Combined Spinal-epidural Analgesia Versus Epidural Analgesia During Labor

Deng Dongrui1 site in 1 country200 target enrollmentJuly 20, 2018

ConditionsLabor Long Labor Pain Labor Fetal Anoxia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Labor Long
Sponsor: Deng Dongrui
Enrollment: 200
Locations: 1
Primary Endpoint: Labor duration
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The investigators want to compare the safety and efficacy between the combined spinal-epidural analgesia and epidural analgesia during labor.

Detailed Description

Participants who request neuraxial labor analgesia are randomized to receive combined spinal-epidural analgesia or epidural analgesia during labor. The investigators collect the data on the duration of three stages of labor, the mode of delivery, neonatal Apgar scores, VAS scores, modified Bromage scores.

Registry

clinicaltrials.gov

Start Date

July 20, 2018

End Date

July 20, 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Deng Dongrui

Responsible Party

Sponsor Investigator

Principal Investigator

Deng Dongrui

Professor, Chief doctor

Tongji Hospital

Eligibility Criteria

Inclusion Criteria

•Healthy women at term (37 to 42 weeks of gestation), vertex presentation, singleton pregnancy who desired vaginal delivery were eligible to participate.

Exclusion Criteria

•Contraindications to neuraxial techniques such as clinically significant coagulopathy and increased intracranial pressure, and patients with preterm labor, multiple pregnancies, non-vertex presentation, cephalopelvic disproportion and severe obstetric complications

Outcomes

Primary Outcomes

Labor duration

Time Frame: At the end of delivery

Duration of three stages of labor

Secondary Outcomes

1 minute and 5 minutes Apgar scores(1 min after delivery, 5 min after delivery.)
Visual Analogue Scores(VAS)(At 5min before analgesia; at 5min, 15min, 30min, 1h after the first dose of analgesic drugs； at cervical dilation of 3cm , 6cm and 10cm; at the time of birth of infant; at the time of delivery of placenta.)
Modified Bromage scores(At 5min before analgesia; at 5min, 15min, 30min, 1h after the first dose of analgesic drugs； at the cervical dilation of 3cm , 6cm and 10cm; at the time of birth of infant; at the time of delivery of placenta.)
The mode of delivery(At the end of delivery)