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Completed

NCT Number: NCT05708469

Sugammadex Administration in Pregnancy

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.

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Key information

Conditions

Sugammadex, Pregnant, Anesthesia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Sakarya University Training and Research Hospital

Serdivan, Sakarya, 54100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Fetal outcome

    Time frame: one week postoperatively

    Determined by using APGAR score.

  2. Preterm labor

    Time frame: Labor that starts before 37 completed weeks of pregnancy

    Labor that starts before 37 completed weeks of pregnancy.

Sponsors and collaborators

Lead sponsor

Sakarya University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2023
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.