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IRCT20190817044544N1 IRCT 2020-01-03 Rafsanjan University of Medical Sciences Effect of intravenous fluid therapy before spinal block on postural headache in women undergoing elective cesarean section Effect of intravenous fluid therapy before spinal block on postural headache in women undergoing elective cesarean section 2018-04-09 anticipated 150 Complete https://irct.ir/trial/41649 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: In women undergoing elective cesarean section, postural puncture headache indices were compared between the two groups for the effect of fluid therapy before spinal anesthesia, Randomization description: Participants in this study were divided into control and intervention groups using simple randomization (random number tables), Blinding description: The population of the study was two groups of women. One group received 500 cc Ringer serum before entering the operating room and the other group did not receive this serum. Patients in our study were aware of serum intake but were unaware of the purpose of serum therapy. 3 Postdural puncture headache. Intervention 1: Intervention group: each containing 75 candidates for elective cesarean section. After a minimum fasting period, women received 500 cc of Ringer serum one hour before the start of the spinal block. The incidence, severity and duration of their headache were evaluated. Intervention 2: Control group: women were admitted to the operating room with a minimum of eight hours of fasting in the morning and received no serum. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "There is no further information"
public fatemeh Jadidi
Imam Ali Boulevard, Ali-Ibn Abi-Talib Hospital
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0185 dr.fjadidi@rums.ac.ir Rafsanjan University of Medical Sciences scientific Fatemeh Jadidi
Imam Ali Boulevard, Ali-Ibn Abi-Talib Hospital
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0185 dr.fjadidi@rums.ac.ir Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Pregnant mothers who are candidates for elective cesarean section. usually fast for 8 hours or more. 15 years 45 years Female Women who suffer from lumbar lordosis, high weight and lack of coordination, numbness in the first instance, or partial numbness, and have to take analgesics and sleep medications to continue. Women who have a history of migraine or tension or headache due to high blood pressure. Rehabilitation Prevention Intervention group: each containing 75 candidates for elective cesarean section. After a minimum fasting period, women received 500 cc of Ringer serum one hour before the start of the spinal block. The incidence, severity and duration of their headache were evaluated. Control group: women were admitted to the operating room with a minimum of eight hours of fasting in the morning and received no serum. Incidence of headache. Timepoint: Women in the two groups were visited for seven days after the intervention for headache. Method of measurement: The specific measurement tool for measuring primary outcome (incidence of headache) is based on a researcher-made checklist. 1-headache severity, 2- day of onset of headache, 3- number of day headaches, 4- frequency need of analgesic, 5-frequency of use. Timepoint: In case of a headache, women are screened daily for other relevant indicators within seven days after delivery. Method of measurement: The specific measurement tool for the severity of headache has been the use of the VAS (Visual Analogue Scale) ruler. None Approved 2018-08-08 Ethics committee of rafsanjan University of Medical Sciences Rafsanjan, Imam Ali Boulevard rafsanjan Kerman Iran (Islamic Republic of)