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

NCT07326644 | Completed

• 1 other identifier: FSH-NEC-GWG-CS-2025
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Regional Anesthesia; Cesarean Delivery; Gestational Weight Gain

Keywords

Gestational weight gain; Spinal anesthesia; Cesarean delivery; Hemodynamic response

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

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

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

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

Interventions

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.

Adequate Gestational Weight Gain; Excessive Gestational Weight Gain; Inadequate Gestational Weight Gain

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Elazıg Fethi Sekin Sehir Hastanesi: lead

Study Sites (1)

Fethi Sekin City Hospital

Elâzığ, Elaziğ, 23050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gestational Weight Gain

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: December 5, 2025
• Primary Completion: August 20, 2026
• Study Completion: August 20, 2026
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)