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

NCT07326644 — Completed, 120 participants, Elazıg Fethi Sekin Sehir Hastanesi

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Effect of Gestational Weight Gain on Regional Anesthesia in Cesarean Patients

Registry	NCT07326644, acronym GWG-CESA
Status	Completed
Study type	Observational
Enrollment	120 (Actual)
Sponsor	Elazıg Fethi Sekin Sehir Hastanesi (Other)
Conditions	Gestational Weight Gain, Regional Anesthesia, Cesarean Delivery
Interventions	Gestational Weight Gain (Other)
Dates	start 2025-12-05, primary completion 2026-08-20, completion 2026-08-20, first posted 2026-01-08, last updated 2026-09-10
Locations	1 site in Turkey (Türkiye)

-Summary

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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+Arms and interventions

Arm	Interventions	Description
Inadequate Gestational Weight Gain	Other: Gestational Weight Gain	Pregnant women whose gestational weight gain is below the recommended range according to the Institute of Medicine (IOM) 2009 guidelines.
Adequate Gestational Weight Gain	Other: 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.
Excessive Gestational Weight Gain	Other: 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).

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.

+Outcome measures

Primary outcomes

Incidence of Spinal Anesthesia-Induced Hypotension [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.

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

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)

+Locations (1)

Facility	City	Country	Status
Fethi Sekin City Hospital	Elâzığ, Elaziğ	Turkey (Türkiye)