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Clinical Trials/NCT03381495
NCT03381495
Unknown
Not Applicable

The Association Between Epidural Labor Analgesia and Pregnancy Outcomes

Deng Dongrui1 site in 1 country200 target enrollmentMay 16, 2018

Overview

Phase
Not Applicable
Intervention
Ropivacaine Hydrochloride, Sufentanil
Conditions
Labor Pain
Sponsor
Deng Dongrui
Enrollment
200
Locations
1
Primary Endpoint
Labor duration
Last Updated
7 years ago

Overview

Brief Summary

Labor analgesia can alleviate intrapartum pain, in the importance of the delivery is very obvious.But some researches think labor analgesia may affect the progress of labor, increase the cesarean section rate.This research adopts the epidural anesthesia to study labor analgesia effects on delivery outcomes and long-term emotional and psychological effects on the mothers. Besides, we also want to study the effect of exercise during pregnancy on the mode of delivery.

Registry
clinicaltrials.gov
Start Date
May 16, 2018
End Date
December 31, 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 and full term pregnant women

Exclusion Criteria

  • the pregnant women with complications

Arms & Interventions

Epidural analgesia during labor

The epidural analgesia technique was used to maintain analgesia for parturients who request labor analgesia.First, we injected a test dose of 5ml 1% lidocaine . If not adverse effects were observed 10 minutes after the test dose, the parturient then received a bolus injection of an initial dose of 8-10 ml mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate. We then connected the epidural catheter with a patient-controlled epidural analgesia (PCA) pump, which provided patients the same mixed solution at 8-10ml/h until the delivery of neonates.

Intervention: Ropivacaine Hydrochloride, Sufentanil

Outcomes

Primary Outcomes

Labor duration

Time Frame: At the end of the delivery

Duration of three stages of labor.

Secondary Outcomes

  • 1 minute Apgar index(1 minute after the infant is born)
  • 5 minute Apgar index(5 minutes after the infant is born)
  • Visual Analogue Scores(VAS)(5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.)
  • Modified Bromage scores(5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.)
  • Postpartum depression(3 days after delivery,6 weeks after delivery, 3 months after delivery, 6 months after delivery, 1 year after delivery.)
  • The mode of delivery(At the end of delivery)

Study Sites (1)

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