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COMPARATIVE STUDY OF LEG WRAPPING VERSUS STANDARD CARE FOR THE PREVENTION OF POSTSPINAL HYPOTENSION IN PATIENTS UNDERGOING ELECTIVE CESAREAN SECTION UNDER SPINAL ANESTHESIA

A COMPARATIVE STUDY OF LEG WRAPPING VERSUS STANDARD CARE FOR THE PREVENTION OF POSTSPINAL HYPOTENSION IN PATIENTS UNDERGOING ELECTIVE CESAREAN SECTION UNDER SPINAL ANESTHESIA - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/111223
Enrollment
110
Registered
2026-05-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: 1- Health Condition 2: O82- Encounter for cesarean delivery without indication Health Condition 3: O82- Encounter for cesarean delivery without indication Health Condition 4: O82- Encounter for cesarean delivery without indication

Interventions

Intervention1: Leg Wrapping: Both legs will be wrapped using 4-inch sterile crepe bandages from ankle to mid-thigh with uniform moderate pressure applied before administration of spinal anesthesia. St

Sponsors

Dr KUMARI NEHA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants giving written informed consent for the study 2. Women aged 18 40 years 3. Term singleton pregnancy (greater than or equal to 37 weeks) 4. Participants classified as ASA Physical status II. 5. Scheduled for elective lower cesarean section under spinal anesthesia.

Exclusion criteria

Exclusion criteria: 1.Refusal or inability to provide well-informed written consent 2.Emergency cesarean section 3.Patients with ASA Physical Status III or IV, indicating significant systemic disease or complications 4.Multiple gestation or polyhydramnios 5.Contraindications to spinal anesthesia 6.Allergy to crepe bandage material 7.Use of medications that may interfere with blood pressure regulation (e.g., vasodilators, betablockers)

Design outcomes

Primary

MeasureTime frame
Incidence of postspinal hypotensionTimepoint: From administration of spinal anesthesia until completion of surgery (blood pressure recorded every 3 minutes for the first 15 minutes and every 5 minutes thereafter until the end of surgery)

Secondary

MeasureTime frame
Severity of postspinal hypotensionTimepoint: From spinal anesthesia until completion of surgery;Total vasopressor (mephentermine) requirementTimepoint: During intraoperative period until completion of surgery;Colloid and blood product requirementsTimepoint: During surgery;Maternal hemodynamic parameters (systolic blood pressure, diastolic blood pressure, mean arterial pressure, heart rate and oxygen saturation)Timepoint: Baseline, every 3 minutes for first 15 minutes after spinal anesthesia and every 5 minutes thereafter until completion of surgery;Incidence of adverse effects associated with leg wrappingTimepoint: Intraoperative period and PACU monitoring period up to 2 hours postoperatively

Countries

India

Contacts

Public ContactDR AJAY KUMAR SINHA

GOVERNMENT MEDICAL COLLEGE , HALDWANI (UTTARAKHAND)

sinhaak1961@gmail.com9897672301

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026