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

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: Recruiting
• Conditions: Gestational Weight Gain; Regional Anesthesia; Cesarean Delivery

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: SAİT F ÖNER, MD, PhD; Phone Number: +905336271358; Email: sfatihoner@gmail.com

Study Locations

• Turkey (Türkiye)
  • Elaziğ
    • Elâzığ, Elaziğ, Turkey (Türkiye), 23050
      • Recruiting
      • Fethi Sekin City Hospital
      • Contact: SAİT F ÖNER, MD, PhD; Phone Number: +905336271358; Email: sfatihoner@gmail.com

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Inadequate Gestational Weight Gain; Pregnant women whose gestational weight gain is below the recommended range according to the Institute of Medicine (IOM) 2009 guidelines.
Adequate or Excessive 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Spinal Anesthesia-Induced Hypotension	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

• Sponsor: Elazıg Fethi Sekin Sehir Hastanesi

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): May 5, 2026
• Study Completion (Estimated): May 10, 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): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Spinal anesthesia; Cesarean delivery; Gestational weight gain; Hemodynamic response
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Gain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gestational Weight Gain
• 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