Childbirth and postpartum care
Conditions
Interventions
Colorimetric measurement of blood loss and gravimetric and volumetric measurement of blood loss
Sponsors
University of Oxford
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: • Women aged 18 or over • Women undergoing birth by caesarean section (elective or semi-emergency [category 2 or 3]) during the study period. Multiple pregnancies will be eligible. • Written informed consent from participants.
Exclusion criteria
Exclusion criteria: • Women undergoing a category 1 (immediate threat to life) caesarean section. • Women undergoing a caesarean section with a planned hysterectomy • Women participating in another PPH study. • Women diagnosed major bleeding disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome will be a composite of any of the following: blood transfusion, Hb <6g/dL or a decrease of 4g/dL or greater from baseline, as well as PPH-related procedures (compression sutures, major vessel ligation or hysterectomy), maternal HDU/ICU admission, or maternal mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe PPH during CS - PPH- defined as =1000 mL measured blood loss intraoperatively during CS (total calculated at the end of the procedure);Blood loss volume during CS in theatre - Volume of blood lost intraoperatively during CS (total calculated at the point of PPH diagnosis and at the end of the procedure) (mL);Primary PPH - blood loss greater than or equal to 500mL within the first 24 hours after delivery. ;Blood transfusion - Transfusion of whole blood or blood products given to the patient to replace that lost during Caesarean section when required;Haemoglobin <6g/dL or a decrease of 4g/dL or greater from baseline - pre-operative Hb taken in the 36 hours preceding surgery; post-operative Hb measurement taken 6-24 hours after surgery. ;PPH-related Hysterectomy - Hysterectomy (surgical removal of uterus) required to control bleeding during or after caesarean section until discharge;Any hysterectomy - Hysterectomy (surgical removal of uterus) required to control bleeding during or after caesarean section until discharge;PPH-related re-laparotomy - Return to theatre and re-laparotomy procedure to facilitate further treatment for PPH. ;Any laparotomy - Return to theatre and re-laparotomy procedure ;PPH-related maternal mortality - Death of a mother from PPH during and after caesarean section up until discharge;All-cause mortality - Death of a mother during and after caesarean section up until discharge;PPH-related admission to the HDU/ICU - Woman requiring admission to HDU/ICU following a caesarean section complicated by bleeding and related sequalae. ;Any admission to the HDU/ICU - Woman requiring admission to HDU/ICU following a caesarean section ;PPH-related major vessel ligation - Uterine and iliac artery ligation are surgical procedures used to control/stop bleeding during caesarean section from the uterus and pelvis in an attempt to preserve the uterus and save the mother’s life. ;Uterine tourniquet - A surgical technique used to temporarily control severe | — |
Countries
India, Kenya, Nigeria, Pakistan, Rwanda
Contacts
Public ContactSindhu Natarajan
Programme Manager
Outcome results
None listed