Incidence of Complications Associated With Anesthesia in Multiple Gestation Undergoing Cesarean Delivery

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT02846129
Collaborator
(none)
1,057
1
9.6
110.2

Study Details

Study Description

Brief Summary

Incidence of anesthesia related complications in multiple gestation patients undergoing cesarean delivery has not been reported in Thailand. The aim of this study is to identify complications that occur which may derived from different anesthetic techniques used, such as hypotension, uterine atony, postpartum hemorrhage, rate of hysterectomy, blood transfusion and fetal outcome.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Nowadays, the rate of multiple gestations is increasing considerably due to the prevalence of assisted reproductive technology. As physiologic changes from multiple gestations differ from singleton pregnancy, multiple gestations are considered a high risk pregnancy. A number of complications can occur from prenatal period such as preterm labor and increase rate of maternal beta agonist usage e.g. ritodrine, terbutaline and salbutamol. These drugs cause maternal tachycardia, hypokalemia and pulmonary edema. Multiple gestations increase rate of cesarean delivery and intraoperative complications such as postpartum hemorrhage and hysterectomy can be found 3.7 times and 2.3 times respectively higher than that of singleton pregnancy.

    Spinal anesthesia is the anesthetic technique of choice for parturients undergoing cesarean section, owing to its rapid onset of action, reliability, superior postoperative pain control and lower mortality rate than general anesthesia. However, the most important complication is maternal hypotension, especially in multiple gestations that may derive from more aortocaval compression comparing with singleton pregnancy. Nevertheless, some patients having contraindications for regional anesthesia e.g. thrombocytopenia, coagulopathy or pulmonary edema make anesthesiologists decide to put these patients under general anesthesia for cesarean section. General anesthesia for cesarean section in singleton pregnancy has been proved that can cause higher incidence of postpartum hemorrhage and higher rate of blood transfusion compared to regional anesthesia.

    Incidence of anesthesia related complications in multiple gestation patients undergoing cesarean delivery has not been reported in Thailand. The aim of this study is to identify complications that occur which may derived from different anesthetic techniques used, such as hypotension, uterine atony, postpartum hemorrhage, rate of hysterectomy, blood transfusion and fetal outcome.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1057 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Incidence of Complications Associated With Anesthesia in Multiple Gestation Undergoing Cesarean Delivery: A Retrospective Review
    Study Start Date :
    Oct 1, 2016
    Actual Primary Completion Date :
    Jul 3, 2017
    Actual Study Completion Date :
    Jul 20, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of complications associated with anesthesia in multiple gestation undergoing cesarean section [Up to 24 hours postoperatively]

    Secondary Outcome Measures

    1. Anesthetic technique used e.g. regional or general anesthesia [Up to 24 hours postoperatively]

    2. Amount of medication used [Up to 24 hours postoperatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pregnant women, multiple gestation underwent cesarean delivery from the past until 31 Dec 2015
    Exclusion Criteria:
    • Preterm delivery before 24 weeks

    • Death fetus in utero

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anesthesiology department, Siriraj hospital, Mahidol University Bangkok Thailand 10700

    Sponsors and Collaborators

    • Mahidol University

    Investigators

    • Principal Investigator: Patchareya Nivatpumin, M.D., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Patchareya Nivatpumin, Assistant professor, Mahidol University
    ClinicalTrials.gov Identifier:
    NCT02846129
    Other Study ID Numbers:
    • 067/2559(EC3)
    First Posted:
    Jul 27, 2016
    Last Update Posted:
    Jul 31, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Patchareya Nivatpumin, Assistant professor, Mahidol University

    Study Results

    No Results Posted as of Jul 31, 2017