Effect of Gestational Weight Gain on Spinal Anesthesia in Elective Cesarean Delivery (GWG-CESA)

September 6, 2026 updated by: Sait Fatih Öner, Elazıg Fethi Sekin Sehir Hastanesi

Effect of Gestational Weight Gain on Regional Anesthesia in Cesarean Patients

This prospective, observational, non-interventional study aims to evaluate the effect of gestational weight gain on regional anesthesia characteristics in pregnant women undergoing elective cesarean delivery. No additional intervention, medication, or procedure beyond routine clinical care will be performed. Participants will be classified according to gestational weight gain categories based on the Institute of Medicine (IOM) 2009 guidelines, and spinal anesthesia block characteristics, hemodynamic responses, and perioperative outcomes will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

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

  • Turkey (Türkiye)
    • Elaziğ
      • Elâzığ, Elaziğ, Turkey (Türkiye), 23050
        • Fethi Sekin City Hospital

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of pregnant women aged 18 to 45 years who are scheduled for elective cesarean delivery under regional (spinal) anesthesia. All participants will be followed prospectively, and no additional intervention beyond routine clinical care will be performed. Gestational weight gain will be calculated using pre-pregnancy and pre-delivery weight records and classified according to the Institute of Medicine (IOM) 2009 guidelines.

Description

Inclusion Criteria:

  • Pregnant women aged 18-45 years

    • Single pregnancy
    • Planned elective cesarean section
    • Spinal anesthesia (regional anesthesia technique)
    • Pre-pregnancy weight information available (maternal health record, e-Nabız or file record)
    • Recorded pre-delivery weight information
    • Gestational weight gain (GWG) calculable according to the IOM 2009 classification
    • ASA I-II pregnant women
    • Voluntary participation in the study and informed consent

Exclusion Criteria:

  • Pregnant women with preeclampsia, severe preeclampsia, eclampsia, or HELLP syndrome

    • Pregnant women with a history of gestational diabetes or pregestational diabetes
    • Multiple pregnancy (twins, triplets, etc.)
    • Preterm pregnancy (<37 weeks)
    • Failure of spinal anesthesia or need for conversion to general anesthesia
    • Lack of pre-pregnancy weight information or weight gain data during pregnancy
    • Pregnancies with fetal anomalies
    • Morbid obesity (BMI ≥ 45 kg/m²)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Inadequate Gestational Weight Gain
Pregnant women whose gestational weight gain is below the recommended range according to the Institute of Medicine (IOM) 2009 guidelines.
Other: Gestational Weight Gain
Participants will be categorized into three groups according to total gestational weight gain based on pre-pregnancy body mass index and the 2009 Institute of Medicine recommendations: inadequate, adequate, and excessive gestational weight gain. No intervention will be performed regarding gestational weight gain; it will be evaluated as an observational exposure.
Adequate Gestational Weight Gain
Pregnant women whose gestational weight gain is within or above the recommended range according to the Institute of Medicine (IOM) 2009 guidelines.
Other: Gestational Weight Gain
Participants will be categorized into three groups according to total gestational weight gain based on pre-pregnancy body mass index and the 2009 Institute of Medicine recommendations: inadequate, adequate, and excessive gestational weight gain. No intervention will be performed regarding gestational weight gain; it will be evaluated as an observational exposure.
Excessive Gestational Weight Gain
Participants whose total gestational weight gain is above the recommended range according to the 2009 Institute of Medicine (IOM) guidelines, based on pre-pregnancy body mass index (BMI).
Other: Gestational Weight Gain
Participants will be categorized into three groups according to total gestational weight gain based on pre-pregnancy body mass index and the 2009 Institute of Medicine recommendations: inadequate, adequate, and excessive gestational weight gain. No intervention will be performed regarding gestational weight gain; it will be evaluated as an observational exposure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Spinal Anesthesia-Induced Hypotension
Time Frame: During cesarean delivery (first 20 minutes after spinal anesthesia)
Occurrence of hypotension following spinal anesthesia, defined as a decrease in mean arterial pressure of ≥20% from baseline or an absolute mean arterial pressure <65 mmHg.
During cesarean delivery (first 20 minutes after spinal anesthesia)

Collaborators and Investigators

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

Sponsor

Elazıg Fethi Sekin Sehir Hastanesi

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 (Actual)

December 5, 2025

Primary Completion (Actual)

August 20, 2026

Study Completion (Actual)

August 20, 2026

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSH-NEC-GWG-CS-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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