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

NCT ID: NCT07326644

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-05

Study Completion Date

2026-03-05

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Weight Gain Regional Anesthesia Cesarean Delivery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Inadequate Gestational Weight Gain

Pregnant women whose gestational weight gain is below the recommended range according to the Institute of Medicine (IOM) 2009 guidelines.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Elazıg Fethi Sekin Sehir Hastanesi

OTHER

Sponsor Role lead

Responsible Party

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Sait Fatih Öner

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fethi Sekin City Hospital

Elâzığ, Elaziğ, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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SAİT F ÖNER, MD, PhD

Role: CONTACT

+905336271358

Facility Contacts

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SAİT F ÖNER, MD, PhD

Role: primary

+905336271358

Other Identifiers

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FSH-NEC-GWG-CS-2025

Identifier Type: -

Identifier Source: org_study_id

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