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

Effect of Gestational Weight Gain on Regional Anesthesia in Cesarean Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07326644
Acronym
GWG-CESA
Enrollment
120
Registered
2026-01-08
Start date
2025-12-05
Completion date
2026-08-20
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery, Gestational Weight Gain, Regional Anesthesia

Keywords

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

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.

Interventions

OTHERGestational 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.

Sponsors

Elazıg Fethi Sekin Sehir Hastanesi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Spinal Anesthesia-Induced HypotensionDuring 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026