NCT07440667 Restrictive vs Liberal Intraoperative Fluid Strategy and Postoperative Outcomes After Elective Cesarean Section
| NCT ID | NCT07440667 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nigde Omer Halisdemir University |
| Condition | Cesarean Section |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-03-04 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2026-03-04 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * Female patients aged 18-45 years * ASA physical status II * Scheduled for elective cesarean section under spinal anesthesia * Provision of written informed consent Exclusion Criteria: * Emergency cesarean section * Preeclampsia or eclampsia * Known cardiac failure * Known renal failure * Known hepatic failure * Coagulopathy * Contraindication to spinal anesthesia * Conversion to general anesthesia * Major technical complications during spinal anesthesia * Refusal to participate
Contact & Investigator
Pınar Erdoğan, Assoc Prof
PRINCIPAL INVESTIGATOR
Niğde Ömer Halisdemir University Hospital
Frequently Asked Questions
Who can join the NCT07440667 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Cesarean Section. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07440667 currently recruiting?
Yes, NCT07440667 is actively recruiting participants. Contact the research team at pinar.erdogan@ohu.edu.tr for enrollment information.
Where is the NCT07440667 trial being conducted?
This trial is being conducted at Niğde, Turkey (Türkiye).
Who is sponsoring the NCT07440667 clinical trial?
NCT07440667 is sponsored by Nigde Omer Halisdemir University. The principal investigator is Pınar Erdoğan, Assoc Prof at Niğde Ömer Halisdemir University Hospital. The trial plans to enroll 160 participants.