Pilot study on the prophylactic use of Cell Salvage in elective Cesarean Section without increased risk of Postpartum Hemorrhage

Pilot study on the prophylactic use of Cell Salvage in elective Cesarean Section without increased risk of Postpartum Hemorrhage - StrongMUM

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035578

Enrollment

Registered

2025-01-13

Start date

2025-01-11

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Anemia O82

Interventions

Group 1: The study plans to recruit 20 patients scheduled for elective cesarean sections without increased risk of perioperative bleeding where intraoperative cell salvage will be utilized. Autologous

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Capacity to consent, scheduled for elective cesarean Section

Exclusion criteria

Exclusion criteria: - Predictable risk factors for blood loss > 1000 ml, modified according to AWMF guideline 015/063: - Previous uterine surgeries (especially cesarean section and transmural myomectomy) - Placenta previa - Multiple pregnancy - Known coagulopathy - Suspected bacterial contamination of the surgical site or evidence thereof - Suspected bacteremia (e.g., sepsis) - Predictable risk factors for an allogeneic blood transfusion, modified according to AWMF guideline 015/063: - Anemia (Hb < 9 g/dl) from 35 weeks of gestation onward

Design outcomes

Primary

Measure	Time frame
The rate of cesarean sections in which the prophylactic use of machine autotransfusion results in the processing and retransfusion of wound blood.	—

Secondary

Measure	Time frame
o SF-36 (Short Form Health Survey): Questionnaire for recording general health health and quality of life at hospital discharge, after 30 and 60 days. days. o Hospital Anxiety and Depression Score (HADS) at hospital discharge, after 30 and 60 days o Estimated intraoperative blood loss, interventions for bleeding and related complications, the preoperative to postoperative change in the hemoglobin levels and postpartum infectious complications. o Time of removal of the urinary catheter o Time of first mobilization after caesarean delivery o Anamnestic and clinical data course of pregnancy, previous illnesses, length of hospital stay, transfusions o Iron metabolism parameters: from an additional study-related blood sample of 7.5 ml blood after the caesarean section	—

Measure

Time frame

o SF-36 (Short Form Health Survey): Questionnaire for recording general health health and quality of life at hospital discharge, after 30 and 60 days. days. o Hospital Anxiety and Depression Score (HADS) at hospital discharge, after 30 and 60 days o Estimated intraoperative blood loss, interventions for bleeding and related complications, the preoperative to postoperative change in the hemoglobin levels and postpartum infectious complications. o Time of removal of the urinary catheter o Time of first mobilization after caesarean delivery o Anamnestic and clinical data course of pregnancy, previous illnesses, length of hospital stay, transfusions o Iron metabolism parameters: from an additional study-related blood sample of 7.5 ml blood after the caesarean section

—

Countries

Germany

Contacts

Public ContactDania Fischer

Universitätsklinikum Heidelberg

Dania.fischer@med.uni-heidelberg.de+4962215636166

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026