Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
Same as current

Summary

Conditions
Blood Transfusion
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Preoperative: 1.To select patients according to the criteria.2.To obtain the consent of the obstetrician, the anesthesiologist, and the patients. Intraoperative:According to local blood transfusion guidelines, obstetric advice, anesthesia advice(tentative: before a blood transfusion maternal's Hb le...

Preoperative: 1.To select patients according to the criteria.2.To obtain the consent of the obstetrician, the anesthesiologist, and the patients. Intraoperative:According to local blood transfusion guidelines, obstetric advice, anesthesia advice(tentative: before a blood transfusion maternal's Hb less than 70g/L or Hb:70-100g/l before a blood transfusion according to the blood transfusion program and doctor's determine to do the blood transfusion),those who need blood transfusion during cesarean section will be randomly assigned to the following two groups: cesarean section using intraoperative blood recovery group (test group). cesarean section using allogeneic blood transfusion group (control group). The theoretical amount of blood transfusion should be based on the following formula: The amount of blood transfusion needed (ML) * Hb= (Hb2-Hb1) * blood volume of blood transfusion Hb1: actual measured hemoglobin; Hb2: target hemoglobin (100 g / L) Blood volume = 100ml/kg * body weight The difference between the actual blood transfusion and the theoretical blood transfusion should be controlled within ± 15% of the theoretical blood transfusion (in terms of hemoglobin), whether the test group or the control group. Postoperative: Calculate the amount of bleeding in the subjects and other related indicators. Follow up: maternal pregnancy again: detection of maternal blood group antibody IgG titer, hemolytic disease of the newborn Statistical data: the specially assigned person is responsible for the data collection. And the data is entryed by two times (the first phase: hospitalization period, the second phase: follow-up), which is by the inspectors to verify the authenticity and traceability.

Tracking Information

NCT #
NCT03429790
Collaborators
Not Provided
Investigators
Study Chair: Fang Gao Smith, M.D. The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University Study Chair: Qingquan Lian, M.D. The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University Principal Investigator: Ting LI, M.D. The Second Affiliated Hospital & Yuying Children hospital of Wenzhou Medical University