Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor

March 18, 2024 updated by: Mahidol University
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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Siriraj Hospital, Mahidol University
        • Contact:
        • Principal Investigator:
          • Patchareya Nivatpumin, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pregnant women whom admitted in labor ward for delivering baby as well as accept to receive epidural analgesia for labor

Description

Inclusion Criteria:

  • Age>,= 18 years
  • Accept epidural analgesia for labor
  • ASA classification I-II

Exclusion Criteria:

  • Unable to communicate Thai

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cesarean delivery after epidural analgesia for labor
Time Frame: From epidural catheter insertion to delivery
Rate of cesarean delivery after patients receive epidural analgesia for relieve labor pain
From epidural catheter insertion to delivery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Patchareya Nivatpumin, M.D., Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 4, 2019

First Submitted That Met QC Criteria

August 28, 2019

First Posted (Actual)

August 29, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 18, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 020/2562 (EC4)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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