High risk of postpartum haemorrhage Pregnancy and Childbirth
Conditions
Interventions
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 pla
Sponsors
Wits Health Consortium
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: Any serious medical conditions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined frequency of adverse device effects and device deficiencies measured using the number of recorded incidents in patient medical records at birth, up to discharge from hospital | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood loss after birth measured using a gravimetric method (ml) at 30 minutes after birth;Blood loss > 500 ml measured using a gravimetric method (ml) at 1 hour after birth;Blood loss > 1000 ml measured using a gravimetric method (ml) at 1 hour after birth;Efficiency of suction measured using ultrasound assessment of residual blood in the uterus or blood expressed from the uterus after tube removal (ml) at 30 minutes after birth;Blood pressure, pulse and shock index measured using blood pressure measurement (mmHg); beats per minute; beats per minute/mmHg at 15 minutes after vaginal birth or caesarean;Haemoglobin levels measured using an automated haematology analyzer (g/dL) at pre-delivery and post-delivery;Blood transfusion (units) from birth to hospital discharge measured using data collected from patient medical notes at at one time point;ICU admission at birth to hospital discharge measured using data collected from patient medical notes of incidents at at one time point;Death by hospital discharge measured using data collected from patient medical notes of incidents at at one time point;Active bleeding from the uterus continuing for more than 10 minutes (main efficacy outcome) measured using data collected from patient medical notes of incidents at at one time point;Any adverse event from birth till hospital discharge measured using data collected from patient medical notes of incidents at at one time point;Pain experienced (no pain/mild /severe/unbearable) measured using an ordinal scale at after birth;Additional interventions to stop bleeding (e.g. more uterotonics, compressive measures, UBT, laparotomy, hysterectomy) after birth till hospital discharge measured using data collected from patient medical notes of incidents at at one time point;Was USTAT effectively inserted? measured using a question (yes/no/unknown) and nominal data recording at after birth;How easy was it for health care providers to insert the suction tube uterine tamponade (easy/moderately | — |
Countries
South Africa
Contacts
Public ContactG Justus Hofmeyr
Outcome results
None listed