Effect of Gestational Weight Gain on Spinal Anesthesia in Elective Cesarean Delivery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorElazıg Fethi Sekin Sehir Hastanesi
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women aged 18-45 years
Single pregnancy
Planned elective cesarean section
Spinal anesthesia (regional anesthesia technique)
Disqualifiers
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)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 2 trial groupsGroup A: Inadequate Gestational Weight Gain
Group B: Adequate or Excessive Gestational Weight Gain
Trial outcomes
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.
Time frame
During cesarean delivery (first 20 minutes after spinal anesthesia)Sponsors and contacts
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Source ClinicalTrials.gov