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IRCT20260818070708N1 IRCT 2026-08-25 Lady reading hospital avoidance of low blood pressure in pregnant women going through cessarean A randomized controlled investigation of crystalloid preloading and co-loading for the avoidance of spinal block-related low blood pressure in parturients undergoing cesarean section 2026-10-09 anticipated 112 Pending https://irct.ir/trial/92652 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible participants will be randomized individually in a 1:1 ratio to the crystalloid preloading or crystalloid co-loading group using computer-generated permuted block randomization with variable block sizes of 4 and 6. A random allocation sequence will be generated before commencement of participant recruitment. Sequentially numbered, opaque, sealed envelopes containing the group assignments will be prepared according to the randomization sequence. After confirmation of eligibility and obtaining informed consent, the next sequential envelope will be opened to determine the participant's allocation. Allocation concealment will be maintained until the time of assignment. No stratification will be used. N/A TO AVOID LOW BLOOD PRESSURE IN PATIENT AFTER CESAREAN SECTION. Intervention 1: Intervention group: Crystalloid coloading. Participants will receive an intravenous crystalloid solution at a dose of 10 mL/kg, administered intravenously immediately after initiation of spinal anesthesia. The crystalloid solution will be infused over approximately 20 minutes. The infusion will be initiated immediately after spinal anesthesia and continued for 20 minutes, according to the predefined study protocol. No additional study-specific fluid intervention will be administered. The type, concentration, brand, and manufacturer of the crystalloid solution used will be documented at the time of administration. Intervention 2: Control group: Crystalloid preloading. Participants will receive an intravenous crystalloid solution at a dose of 10 mL/kg, administered intravenously 20 minutes before initiation of spinal anesthesia. The crystalloid solution will be infused over approximately 20 minutes using an intravenous infusion, according to the predefined study protocol. No additional study-specific fluid intervention will be administered. The type, concentration, brand, and manufacturer of the crystalloid solution used will be documented at the time of administration. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only When: starting 6 months after publication To whom: only available for people working in academic institutions Conditions: Data and documents may be used for legitimate scientific and academic research purposes, subject to applicable ethical requirements, institutional policies, and protection of participant confidentiality Where to obtain: The requested documents will be obtainable from the principal investigator upon reasonable request. How to obtain: Requests may be submitted by email to the contact person listed in the IRCT registration and will be considered subject to applicable ethical, institutional, and confidentiality requirements Comments:
public Faiza Shabbir
lady reading hospital, near balahisar fort, peshawar, pakistan
peshawar Pakistan 25000 +92 345 9192727 khurramyounas17@yahoo.com lady reading hospital scientific Faiza Shabbir
Seithi bangla, seithi town, haji camp, peshawar
Peshawar Pakistan 25000 +92 345 9192727 khurramyounas17@yahoo.com Lady reading hospital Pakistan Term pregnancy (≥37 completed weeks of gestation) Scheduled for cesarean section under spinal anesthesia Baseline hemodynamically stable before spinal anesthesia. Able to provide written informed consent to participate in the study 18 years 40 years Female Patient refusal or inability to provide informed consent Contraindication to spinal anesthesia or planned general anesthesia. Emergency cesarean section requiring immediate general anesthesia O74.6 Other complications of spinal and epidural anesthesia during labor and delivery Treatment - Other Treatment - Other Intervention group: Crystalloid coloading. Participants will receive an intravenous crystalloid solution at a dose of 10 mL/kg, administered intravenously immediately after initiation of spinal anesthesia. The crystalloid solution will be infused over approximately 20 minutes. The infusion will be initiated immediately after spinal anesthesia and continued for 20 minutes, according to the predefined study protocol. No additional study-specific fluid intervention will be administered. The type, concentration, brand, and manufacturer of the crystalloid solution used will be documented at the time of administration. Control group: Crystalloid preloading. Participants will receive an intravenous crystalloid solution at a dose of 10 mL/kg, administered intravenously 20 minutes before initiation of spinal anesthesia. The crystalloid solution will be infused over approximately 20 minutes using an intravenous infusion, according to the predefined study protocol. No additional study-specific fluid intervention will be administered. The type, concentration, brand, and manufacturer of the crystalloid solution used will be documented at the time of administration. Stable normal blood pressure. Timepoint: Intraoperative period (from spinal anesthesia until 30 minutes after spinal anesthesia). Method of measurement: sphygmomonomete. Lady reading hospital Approved 2025-05-19 Lady reading hospital Institutional review board Lady reading hospital, near balahisar fort, Peshawar, Pakistan Peshawar Kpk Pakistan