Equity for suction tamponade access to treat postpartum haemorrhage: The ESTA project
High risk of postpartum haemorrhage
The method of randomisation was sequentially numbered, sealed opaque envelopes with allocations in computer-generated random sequence to intervention and routine care. USTAT purpose-designed soft plastic suction catheter inserted into the uterus after vaginal or caesarean birth to reduce the risk of postpartum haemorrhage in consented participants at high risk of postpartum haemorrhage. Low-pressure suction applied (approx. 100 mmHg). Suction stopped after 30 minutes. If no further bleeding, tube removed. If bleeding resumes, suction continued. If bleeding not controlled within 20 min (or sooner if clinically indicated), proceed to further management according to local standard of care protocols (these might include additional uterotonics, tranexamic acid, compression methods, uterine balloon tamponade or laparotomy). Control: Routine care
1. Age 18 years and older 2. Planned vaginal or caesarean birth 3. One or more risk factors for PPH, including: 3.1. Previous PPH 3.2. Hypertension and pre-eclampsia 3.3. Induction of labour 3.4. Emergency caesarean birth 3.5. Anaemia 3.6. Multiple pregnancy 3.7. Polyhydramnios 3.8. Macrosomia 3.9. Antepartum haemorrhage
Any serious medical conditions