Sugammadex Administration in Pregnancy

January 31, 2023 updated by: Sakarya University

Maternal and Fetal Outcomes of Sugammadex Administration During Pregnancy: A Retrospective Cohort Study

In this study, the investigators aimed to evaluate the maternal and fetal effect of sugammadex in pregnant patients undergoing a non-obstetric surgery. The investigators mainly focused on the short- and long-term adverse effects such as an abortion or a teratogenic effect and that may occur in fetus and the adverse effects that may be seen in mother.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Since the approval in Europe in 2008, sugammadex has been widely studied among pregnant patients in the context of cesarean deliveries. However, the use of sugammadex in pregnant patients undergoing a non-obstetric surgery is not clearly defined. The package insert indicates that there are no data on its use in pregnant women regarding the drug-associated risks. There are some questions raised, and answers needed from the scientific community about the maternal and fetal effect of sugammadex administered in pregnant patients.

This is a retrospective case-control cohort study which was conducted in a single-center territory university hospital. The investigators used the hospital information management system for determining the patients that are eligible for inclusion. Patients operated between January 2017 and june 2022 were included in the study. Patient data was obtained by manual review of anesthesia charts of eligible patients. Pregnant patients who underwent a non-pregnancy surgical intervention within the study period were included in the study.

Study Type

Observational

Enrollment (Anticipated)

35

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 to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who were operated under general anesthesia during pregnancy and used sugammadex during the recovery period will be included in the study. The study was planned retrospectively. We determined the age group as 18-45.

Description

Inclusion Criteria:

  • Pregnant women who were operated under general anesthesia during pregnancy and who used sugammadex during the awakening phase.

Exclusion Criteria:

  • Patients with severe hepatic and renal impairment
  • Patients with missing data
  • Patients with fetal anomaly detected before the procedure

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fetal outcome
Time Frame: one week postoperatively
Determined by using APGAR score.
one week postoperatively
Preterm labor
Time Frame: Labor that starts before 37 completed weeks of pregnancy
Labor that starts before 37 completed weeks of pregnancy.
Labor that starts before 37 completed weeks of pregnancy

Collaborators and Investigators

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

Sponsor

Sakarya 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 (ANTICIPATED)

March 15, 2023

Primary Completion (ANTICIPATED)

June 15, 2023

Study Completion (ANTICIPATED)

August 15, 2023

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ACTUAL)

February 1, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • sakarya ali eman 001

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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