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

July 28, 2017 updated by: Patchareya Nivatpumin, Mahidol University

Incidence of Complications Associated With Anesthesia in Multiple Gestation Undergoing Cesarean Delivery: A Retrospective Review

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1057

Contacts and Locations

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

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Anesthesiology department, Siriraj hospital, Mahidol University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women, multiple gestation e.g. twin, triplet, quadruplet undergoing cesarean section.

Description

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

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: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of complications associated with anesthesia in multiple gestation undergoing cesarean section
Time Frame: Up to 24 hours postoperatively
Up to 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Anesthetic technique used e.g. regional or general anesthesia
Time Frame: Up to 24 hours postoperatively
Up to 24 hours postoperatively
Amount of medication used
Time Frame: Up to 24 hours postoperatively
Up to 24 hours postoperatively

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., Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand

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

October 1, 2016

Primary Completion (Actual)

July 3, 2017

Study Completion (Actual)

July 20, 2017

Study Registration Dates

First Submitted

March 13, 2016

First Submitted That Met QC Criteria

July 24, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

July 31, 2017

Last Update Submitted That Met QC Criteria

July 28, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 067/2559(EC3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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