Gestational Weight GainGWG-CESANCT07326644
Effect of Gestational Weight Gain on Spinal Anesthesia in Elective Cesarean Delivery
An observational study of Gestational Weight Gain and Regional Anesthesia, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Weight Gain, Regional Anesthesia, Cesarean Delivery
- What is being tested?
- Gestational Weight Gain
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2025to 20 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Show all 9Show fewer
- Gestational weight gain (GWG) calculable according to the IOM 2009 classification
- ASA I-II pregnant women
- Voluntary participation in the study and informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fethi Sekin City Hospital
Elâzığ, Elaziğ, 23050
About this study
Official title: Effect of Gestational Weight Gain on Regional Anesthesia in Cesarean Patients
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.
- Being tested
- Gestational Weight Gain
- Keywords
- Gestational weight gain, Spinal anesthesia, Cesarean delivery, Hemodynamic response
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gestational Weight GainOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Inadequate Gestational Weight Gain | Pregnant women whose gestational weight gain is below the recommended range according to the Institute of Medicine (IOM) 2009 guidelines. Receives: 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. Receives: 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). Receives: Other: Gestational Weight Gain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During cesarean delivery (first 20 minutes after spinal anesthesia)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start5 Dec 2025
- Primary completion20 Aug 2026
- Study completion20 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sait Fatih Öner, Elazıg Fethi Sekin Sehir Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326644
- Sponsor's protocol ID
- FSH-NEC-GWG-CS-2025
- Acronym
- GWG-CESA
- Status last verified
- Sep 2026
- First submitted
- 24 Dec 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gestational Weight Gain on Regional Anesthesia in Cesarean Patients
- ClinicalTrials.gov ID
- NCT07326644
- Acronym / sponsor ID
- GWG-CESA / FSH-NEC-GWG-CS-2025
- Keywords
- Gestational weight gain, Spinal anesthesia, Cesarean delivery, Hemodynamic response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Aug 2026 (actual)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inadequate Gestational Weight Gain | – | Other: Gestational Weight GainPregnant 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 GainPregnant 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 GainParticipants 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (9 listed)
- Pregnant women aged 18-45 years
Key exclusion criteria (8 listed)
- Pregnant women with preeclampsia, severe preeclampsia, eclampsia, or HELLP syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gestational Weight GainParticipants 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. | Other | Adequate Gestational Weight Gain, Excessive Gestational Weight Gain, Inadequate Gestational Weight Gain |
Primary outcome
Incidence of Spinal Anesthesia-Induced Hypotension
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Weight Gain and Regional Anesthesia, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Spinal Anesthesia-Induced Hypotension (time frame: During cesarean delivery (first 20 minutes after spinal anesthesia)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.