Effect of intravenous vitamin C on postoperative hemoglobin level in women undergoing elective cesarean delivery. Intravenous vitamin C, elective cesarean delivery, postoperative hemoglobin level, randomized double blind placebo-control trial
Conditions
Interventions
Participants receive intravenous vitamin C 1000 mg diluted in 100 mL of normal saline solution for at least 1 hour before elective cesarean delivery.,Participants receive 100 mL of normal saline solut
Experimental Drug,Placebo Comparator Drug
Intravenous vitamin C,Placebo
Sponsors
Hospital research Fund, rajavithi hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Participants are singleton pregnant women undergoing elective cesarean delivery. 2. Participants are between 18 and 45 years of age. 3. Participants are able to understand and communicate in Thai with adequate comprehension. 4. Participants have a preoperative hemoglobin level of at least 10 g per dL. 5. Participants have a preoperative platelet count of at least 100,000 cells per microliter. 6. Participants provide written informed consent to participate in this study.
Exclusion criteria
Exclusion criteria: 1. Participants with a history of smoking, alcohol consumption, or substance abuse. 2. Participants with diseases or conditions associated with coagulation disorders, including the use of anticoagulant and or antiplatelet medications. 3. Participants with renal diseases or disorders, including nephrolithiasis, solitary kidney, or serum creatinine level of at least 2 mg per dL. 4. Participants with hepatic diseases or disorders, including liver cirrhosis or hepatitis, or liver enzyme levels (AST or ALT) greater than two times the upper limit of normal. 5. Participants with cardiovascular diseases or disorders, including coronary artery disease, cardiomegaly, heart failure, or atherosclerosis. 6. Participants with a history of deep venous thrombosis and/or pulmonary embolism. 7. Participants with chronic hypertension, gestational hypertension, or preeclampsia. 8. Participants with HIV infection. 9. Participants with polyhydramnios, defined as an amniotic fluid index greater than 25 cm by ultrasonography. 10. Participants with placenta previa or placenta accreta. 11. Participants with a history of two or more previous cesarean deliveries. 12. Participants with fetal macrosomia, defined as an estimated fetal weight greater than 4,000 g. 13. Participants with fetal anomalies. 14. Participants with contraindications to vitamin C administration, including History of oxalate nephrolithiasis, kidney stones, urinary stones, hematuria, or elevated urinary oxalate levels, History of gout or hyperuricemia with inflammatory arthritis, Diagnosed glucose-6-phosphate dehydrogenase (G6PD) deficiency or unexplained hemolytic anemia, Diagnosed paroxysmal nocturnal hemoglobinuria (PNH) or unexplained hemolytic anemia, History of ascorbic acid hypersensitivity or adverse reactions to high-dose vitamin C including rash, diarrhea, nausea and abdominal pain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative hemoglobin levels 24 hours postoperatively Hemoglobin level as mg per dL measured from venous blood samples using an automated hematology analyzer at 24 hours after cesarean delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Total intraoperative blood loss In operation Total blood loss as ml measured from placental delivery until completion of cesarean section surgery.,Postoperative hemoglobin levels 72 hours postoperatively Hemoglobin level as mg per dL measured from venous blood samples using an automated hematology analyzer at 72 hours after cesarean delivery.,Coagulation profiles 72 hours postoperatively coagulation profiles (PT, PTT, and INR) measured from venous blood samples using standard laboratory assay at 72 hours after cesarean delivery.,Incidence of postpartum hemorrhage In operation Number of participants with postpartum hemorrhage assessed by cumulative intraoperative blood loss of at least 1,000 mL.,Proportion of Blood transfusion During and after cesarean delivery Number of participants requiring blood transfusion during or after cesarean delivery.,Additional uterotonic drugs used In operation Number and type of additional uterotonic drugs administered during cesarean delivery.,Operative time In operation Operative time measured as minute from the beginning to completion of surgery.,Postoperative infections Postoperative days 3 and 7. Number and type of postoperative infections following cesarean delivery, including fever, urinary tract infection, mastitis, and surgical site infection., Additional postoperative analgesic requirement. 72 hours postoperatively Number and type of additional postoperative analgesic drug beyond standard care from completion of surgery until 72 hours postoperatively,Length of hospital stay From complete cesarean delivery until hospital discharge Length of hospital stay measured as the number of days from completion of surgery until hospital discharge.,Adverse events During and after drug administration. Number of adverse events, including injection site irritation, diarrhea, nausea, and abdominal pain.,Neonatal outcomes After cesarean delivery Including neonatal birth weight and APGAR score. ,Neonatal morbidity After cesarean delivery | — |
Countries
Thailand
Contacts
Public ContactPutsarat Insin
Rajavithi hospital
Outcome results
None listed