Cesarean SectionNCT07440667
Restrictive vs Liberal Intraoperative Fluid Strategy and Postoperative Outcomes After Elective Cesarean Section
A study testing Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h) and Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h) in people with Cesarean Section and Postoperative Nausea and Vomiting (PONV), run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia for elective cesarean section is frequently associated with hemodynamic instability and postoperative complications such as postoperative nausea and vomiting (PONV) and delayed gastrointestinal recovery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section, Postoperative Nausea and Vomiting (PONV), Postdural Puncture Headache (PDPH)
- What is being tested?
- Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h) and Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Female patients aged 18-45 years
- ASA physical status II
- Scheduled for elective cesarean section under spinal anesthesia
- Provision of written informed consent
Who cannot join
- Emergency cesarean section
- Preeclampsia or eclampsia
- Known cardiac failure
- Known renal failure
- Known hepatic failure
- Coagulopathy
Show all 10Show fewer
- Contraindication to spinal anesthesia
- Conversion to general anesthesia
- Major technical complications during spinal anesthesia
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Niğde Ömer Halisdemir University Hospital
Niğde, Merkez, 51240
Pınar Erdoğan, Assoc. Prof., 05233646954, drpinarerdogan@gmail.com
About this study
Official title: A Prospective Randomized Controlled Trial Comparing Restrictive and Liberal Intraoperative Fluid Strategies on Postoperative Nausea and Vomiting and Gastrointestinal Recovery After Elective Cesarean Section Under Spinal Anesthesia
Spinal anesthesia for elective cesarean section is frequently associated with hemodynamic instability and postoperative complications such as postoperative nausea and vomiting (PONV) and delayed gastrointestinal recovery. Although intraoperative fluid administration is routinely used to prevent spinal-induced hypotension, the optimal fluid strategy remains unclear. Both restrictive and liberal fluid approaches may influence maternal hemodynamics and postoperative outcomes through different physiological mechanisms.
This prospective, single-center, randomized controlled trial aims to compare restrictive (≤3 mL/kg/h) and liberal (>3 mL/kg/h) intraoperative crystalloid fluid strategies in patients undergoing elective cesarean section under spinal anesthesia. The primary outcome is the incidence of PONV within the first 24 hours postoperatively. Secondary outcomes include postdural puncture headache (PDPH), time to first flatus, hypotension frequency, and vasopressor requirements.
Read the detailed description
Spinal anesthesia is the preferred anesthetic technique for elective cesarean section; however, it is frequently associated with sympathetic blockade-induced hypotension. Intraoperative crystalloid administration is commonly used to mitigate hemodynamic instability, yet the optimal fluid strategy remains controversial. Liberal fluid administration may reduce the incidence or severity of hypotension but can contribute to tissue edema, including gastrointestinal wall edema, potentially delaying the recovery of bowel function. Conversely, restrictive fluid strategies may limit fluid overload but could increase vasopressor requirements and compromise splanchnic perfusion. The balance between these approaches and their influence on postoperative maternal outcomes has not been clearly established.
Postoperative nausea and vomiting (PONV) remains one of the most common and distressing complications following cesarean section. Hemodynamic fluctuations, vasopressor use, and visceral perfusion changes may all contribute to its development. In addition, delayed gastrointestinal recovery and postdural puncture headache (PDPH) are relevant postoperative outcomes that may be influenced by intraoperative fluid management.
This prospective, single-center, parallel-group randomized controlled trial is designed to compare two intraoperative crystalloid fluid strategies in patients undergoing elective cesarean section under spinal anesthesia. Patients will be randomized in a 1:1 ratio to receive either a restrictive (≤3 mL/kg/h) or a liberal (>3 mL/kg/h) intraoperative fluid approach. All other anesthetic procedures, spinal technique, and perioperative management will be standardized according to institutional protocol.
The primary outcome of the study is the incidence of PONV within the first 24 postoperative hours. Secondary outcomes include the incidence and severity of PDPH, time to first flatus as a marker of gastrointestinal recovery, frequency of hypotension, and vasopressor requirements. Intraoperative hemodynamic parameters and fluid administration data will be recorded prospectively.
The study aims to clarify whether intraoperative fluid volume influences postoperative maternal recovery and to contribute evidence toward optimizing perioperative fluid management in elective cesarean section.
- Conditions
- Cesarean Section, Postoperative Nausea and Vomiting (PONV), Postdural Puncture Headache (PDPH), Postoperative Ileus, Gastrointestinal Recovery
- Being tested
- Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h), Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h)
- Keywords
- Cesarean Section, Spinal Anesthesia, Intraoperative Fluid Therapy, Restrictive Fluid Strategy, Liberal Fluid Strategy, Postoperative Nausea and Vomiting, Postdural Puncture Headache, Gastrointestinal Recovery, Hypotension, Vasopressor Use
- Medical subject headings
- Postoperative Nausea and Vomiting, Post-Dural Puncture Headache, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h)Other
Intraoperative crystalloid administration targeting an average rate of ≤3 mL/kg/h during elective cesarean section under spinal anesthesia.
Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h)Other
Intraoperative crystalloid administration targeting an average rate of >3 mL/kg/h during elective cesarean section under spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Restrictive intraoperative fluid strategy (≤3 mL/kg/h) | Experimental | Participants undergoing elective cesarean section under spinal anesthesia will receive intraoperative crystalloid at a target average infusion rate of ≤3 mL/kg/h. Standardized spinal anesthesia technique and intraoperative management will be applied. Hypotension will be treated according to the predefined rescue protocol (e.g., ephedrine and/or additional fluid bolus as clinically indicated). Receives: Other: Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h) |
| Liberal intraoperative fluid strategy (>3 mL/kg/h) | Active comparator | Participants undergoing elective cesarean section under spinal anesthesia will receive intraoperative crystalloid at a target average infusion rate of >3 mL/kg/h. Standardized spinal anesthesia technique and intraoperative management will be applied. Hypotension will be treated according to the predefined rescue protocol (e.g., ephedrine and/or additional fluid bolus as clinically indicated). Receives: Other: Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting (PONV)
Occurrence of nausea and/or vomiting within the first 24 hours after surgery, recorded as present or absent.
Measured: 0-24 hours postoperatively
Secondary outcomes (4)
Incidence and severity of postdural puncture headache (PDPH)
Occurrence of postdural puncture headache (PDPH) within 72 hours postoperatively. Severity will be assessed using a standardized pain scale (e.g., numerical rating scale).
Measured: 24-72 hours postoperatively
Time to first flatus
Time (in hours) from the end of surgery to the first reported passage of flatus.
Measured: Up to 72 hours postoperatively
Frequency of intraoperative hypotension
Number of hypotensive episodes defined as systolic blood pressure <90 mmHg or a decrease >20% from baseline.
Measured: Intraoperative period
Total intraoperative vasopressor dose
Cumulative dose of ephedrine administered during surgery.
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start4 Mar 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to one of two parallel groups receiving either a restrictive (≤3 mL/kg/h) or a liberal (\>3 mL/kg/h) intraoperative crystalloid fluid strategy during elective cesarean section under spinal anesthesia. Each participant is assigned to a single intervention arm and followed for postoperative outcomes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seval KILBASANLI, Nigde Omer Halisdemir University
- Investigators
- Pınar Erdoğan, Assoc Prof, Principal investigator, Niğde Ömer Halisdemir University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440667
- Sponsor's protocol ID
- 2025/154
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to institutional policies and ethical considerations related to patient confidentiality. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to approval by the institutional ethics committee and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Comparing Restrictive and Liberal Intraoperative Fluid Strategies on Postoperative Nausea and Vomiting and Gastrointestinal Recovery After Elective Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07440667
- Acronym / sponsor ID
- 2025/154
- Conditions
- Cesarean Section, Postoperative Nausea and Vomiting (PONV), Postdural Puncture Headache (PDPH), Postoperative Ileus, Gastrointestinal Recovery
- Keywords
- Cesarean Section, Spinal Anesthesia, Intraoperative Fluid Therapy, Restrictive Fluid Strategy, Liberal Fluid Strategy, Postoperative Nausea and Vomiting, Postdural Puncture Headache, Gastrointestinal Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 27 Feb 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.
Spinal anesthesia for elective cesarean section is frequently associated with hemodynamic instability and postoperative complications such as postoperative nausea and vomiting (PONV) and delayed gastrointestinal recovery. Although intraoperative fluid administration is routinely used to prevent spinal-induced hypotension, the optimal fluid strategy remains unclear. Both restrictive and liberal fluid approaches may influence maternal hemodynamics and postoperative outcomes through different physiological mechanisms.
This prospective, single-center, randomized controlled trial aims to compare restrictive (≤3 mL/kg/h) and liberal (>3 mL/kg/h) intraoperative crystalloid fluid strategies in patients undergoing elective cesarean section under spinal anesthesia. The primary outcome is the incidence of PONV within the first 24 hours postoperatively. Secondary outcomes include postdural puncture headache (PDPH), time to first flatus, hypotension frequency, and vasopressor requirements.
Detailed description
Spinal anesthesia is the preferred anesthetic technique for elective cesarean section; however, it is frequently associated with sympathetic blockade-induced hypotension. Intraoperative crystalloid administration is commonly used to mitigate hemodynamic instability, yet the optimal fluid strategy remains controversial. Liberal fluid administration may reduce the incidence or severity of hypotension but can contribute to tissue edema, including gastrointestinal wall edema, potentially delaying the recovery of bowel function. Conversely, restrictive fluid strategies may limit fluid overload but could increase vasopressor requirements and compromise splanchnic perfusion. The balance between these approaches and their influence on postoperative maternal outcomes has not been clearly established.
Postoperative nausea and vomiting (PONV) remains one of the most common and distressing complications following cesarean section. Hemodynamic fluctuations, vasopressor use, and visceral perfusion changes may all contribute to its development. In addition, delayed gastrointestinal recovery and postdural puncture headache (PDPH) are relevant postoperative outcomes that may be influenced by intraoperative fluid management.
This prospective, single-center, parallel-group randomized controlled trial is designed to compare two intraoperative crystalloid fluid strategies in patients undergoing elective cesarean section under spinal anesthesia. Patients will be randomized in a 1:1 ratio to receive either a restrictive (≤3 mL/kg/h) or a liberal (>3 mL/kg/h) intraoperative fluid approach. All other anesthetic procedures, spinal technique, and perioperative management will be standardized according to institutional protocol.
The primary outcome of the study is the incidence of PONV within the first 24 postoperative hours. Secondary outcomes include the incidence and severity of PDPH, time to first flatus as a marker of gastrointestinal recovery, frequency of hypotension, and vasopressor requirements. Intraoperative hemodynamic parameters and fluid administration data will be recorded prospectively.
The study aims to clarify whether intraoperative fluid volume influences postoperative maternal recovery and to contribute evidence toward optimizing perioperative fluid management in elective cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to one of two parallel groups receiving either a restrictive (≤3 mL/kg/h) or a liberal (>3 mL/kg/h) intraoperative crystalloid fluid strategy during elective cesarean section under spinal anesthesia. Each participant is assigned to a single intervention arm and followed for postoperative outcomes.
| Arm | Type | Receives |
|---|---|---|
| Restrictive intraoperative fluid strategy (≤3 mL/kg/h) | Experimental | Other: Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h)Participants undergoing elective cesarean section under spinal anesthesia will receive intraoperative crystalloid at a target average infusion rate of ≤3 mL/kg/h. Standardized spinal anesthesia technique and intraoperative management will be applied. Hypotension will be treated according to the predefined rescue protocol (e.g., ephedrine and/or additional fluid bolus as clinically indicated). |
| Liberal intraoperative fluid strategy (>3 mL/kg/h) | Active comparator | Other: Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h)Participants undergoing elective cesarean section under spinal anesthesia will receive intraoperative crystalloid at a target average infusion rate of >3 mL/kg/h. Standardized spinal anesthesia technique and intraoperative management will be applied. Hypotension will be treated according to the predefined rescue protocol (e.g., ephedrine and/or additional fluid bolus as clinically indicated). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients aged 18-45 years
- ASA physical status II
- Scheduled for elective cesarean section under spinal anesthesia
- Provision of written informed consent
Key exclusion criteria (10 listed)
- Emergency cesarean section
- Preeclampsia or eclampsia
- Known cardiac failure
- Known renal failure
- Known hepatic failure
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 |
|---|---|---|
| Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h)Intraoperative crystalloid administration targeting an average rate of ≤3 mL/kg/h during elective cesarean section under spinal anesthesia. | Other | Restrictive intraoperative fluid strategy (≤3 mL/kg/h) |
| Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h)Intraoperative crystalloid administration targeting an average rate of >3 mL/kg/h during elective cesarean section under spinal anesthesia. | Other | Liberal intraoperative fluid strategy (>3 mL/kg/h) |
Primary outcome
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 0-24 hours postoperatively
Occurrence of nausea and/or vomiting within the first 24 hours after surgery, recorded as present or absent.
4 secondary outcomes
Incidence and severity of postdural puncture headache (PDPH)
Time frame: 24-72 hours postoperatively
Time to first flatus
Time frame: Up to 72 hours postoperatively
Frequency of intraoperative hypotension
Time frame: Intraoperative period
Total intraoperative vasopressor dose
Time frame: Intraoperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly shared due to institutional policies and ethical considerations related to patient confidentiality. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to approval by the institutional ethics committee and data protection regulations.
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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.
Pınar Erdoğan, Assoc Prof principal investigator
Niğde Ömer Halisdemir University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrictive intraoperative crystalloid fluid strategy (≤3 mL/kg/h) and Liberal intraoperative crystalloid fluid strategy (>3 mL/kg/h) in people with Cesarean Section and Postoperative Nausea and Vomiting (PONV), run by Nigde Omer Halisdemir University 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 4 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pınar Erdoğan, Assoc. Prof. (+905233646954, pinar.erdogan@ohu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (PONV) (time frame: 0-24 hours postoperatively). 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 Mar 2026.