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Completed

NCT Number: NCT07326644

Effect of Gestational Weight Gain on Spinal Anesthesia in Elective Cesarean Delivery

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.

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Key information

Conditions

Gestational Weight Gain Body Weight Body Weight Changes Cesarean Delivery Pathological Conditions, Signs and Symptoms Regional Anesthesia Signs and Symptoms Weight Gain

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Fethi Sekin City Hospital

Elâzığ, Elaziğ, 23050, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Gestational Weight Gain

Other

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Other

Registry information

Official study title

Effect of Gestational Weight Gain on Regional Anesthesia in Cesarean Patients

Acronym: GWG-CESA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Sep 10, 2026

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.

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