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NCT04074005 Clinical Trial

Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor

Cesarean Section Clinical Trial

Official title:
Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04074005
Other study ID # 020/2562 (EC4)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Mahidol University
Contact Patchareya Nivatpumin, M.D.
Phone +66896662187
Email patchareya.niv@mahidol.ac.th
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied.

Description:

Epidural analgesia with local anesthetic and opioid is the efficiently good method to relieve labor pain comparing with intravenous opioid analgesic. Many literatures reported effects epidural analgesia for labor eg. prolonging the duration of second stage of labor, increasing the rate of instrumental delivery: vacuum extraction and forceps assisting labor. Some papers revealed the increasing in the rate of cesarean delivery. The main reason is assume to be a failure to progress labor after epidural analgesia. However, the recent report from Cochrane database systematic review showed no relation of epidural analgesia for labor and the increasing in the rate of cesarean delivery. Various factors that may involve in the increasing in the rate of cesarean delivery including the dilatation of cervix at the time of insertion of epidural catheter, nulliparous, size of the fetus or motor weakness after receiving epidural medication. The rate of cesarean delivery after epidural analgesia for labor has not been reported in our institute. The aim of this study is to elucidate incidence of cesarean delivery in parturient whom received epidural analgesia. Besides, factors associated with the rate of cesarean delivery were studied.

Recruitment information / eligibility
Status Recruiting
Enrollment 226
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age>,= 18 years - Accept epidural analgesia for labor - ASA classification I-II Exclusion Criteria: - Unable to communicate Thai

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Thailand Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of cesarean delivery after epidural analgesia for labor Rate of cesarean delivery after patients receive epidural analgesia for relieve labor pain From epidural catheter insertion to delivery
Secondary Factors affecting rate of cesarean delivery after epidural analgesia for labor cervical dilatation before insertion epidural catheter (cm.) at the time epidural catheter insertion
Secondary Efficacy of epidural analgesia for labor pain score (verbal rating scale pain score) before and after epidural catheter insertion
Secondary Side effects of epidural analgesia for labor: nausea and vomiting nausea and vomiting (rating by patients: 0= no symptom, 1= nausea 2= vomiting) From epidural catheter insertion to delivery
Secondary Side effects of epidural analgesia for labor: pruritus pruritus (0=no, 1=yes) From epidural catheter insertion to delivery
Secondary Side effects of epidural analgesia for labor: numbness of legs numbness of legs (0=no, 1=yes) From epidural catheter insertion to delivery
Secondary Side effects of epidural analgesia for labor: motor weakness Rate motor weakness by Bromage score From epidural catheter insertion to delivery
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