Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04074005
Collaborator
(none)
226
1
40
5.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    226 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Incidence and Factors Involving Cesarean Delivery After Epidural Analgesia for Labor
    Actual Study Start Date :
    Sep 1, 2019
    Anticipated Primary Completion Date :
    Jul 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of cesarean delivery after epidural analgesia for labor [From epidural catheter insertion to delivery]

      Rate of cesarean delivery after patients receive epidural analgesia for relieve labor pain

    Secondary Outcome Measures

    1. Factors affecting rate of cesarean delivery after epidural analgesia for labor [at the time epidural catheter insertion]

      cervical dilatation before insertion epidural catheter (cm.)

    2. Efficacy of epidural analgesia for labor [before and after epidural catheter insertion]

      pain score (verbal rating scale pain score)

    3. Side effects of epidural analgesia for labor: nausea and vomiting [From epidural catheter insertion to delivery]

      nausea and vomiting (rating by patients: 0= no symptom, 1= nausea 2= vomiting)

    4. Side effects of epidural analgesia for labor: pruritus [From epidural catheter insertion to delivery]

      pruritus (0=no, 1=yes)

    5. Side effects of epidural analgesia for labor: numbness of legs [From epidural catheter insertion to delivery]

      numbness of legs (0=no, 1=yes)

    6. Side effects of epidural analgesia for labor: motor weakness [From epidural catheter insertion to delivery]

      Rate motor weakness by Bromage score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age>,= 18 years

    • Accept epidural analgesia for labor

    • ASA classification I-II

    Exclusion Criteria:
    • Unable to communicate Thai

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Siriraj Hospital, Mahidol University Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahidol University
    ClinicalTrials.gov Identifier:
    NCT04074005
    Other Study ID Numbers:
    • 020/2562 (EC4)
    First Posted:
    Aug 29, 2019
    Last Update Posted:
    Sep 8, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahidol University

    Study Results

    No Results Posted as of Sep 8, 2021