Prevention of postpartum haemorrhage, tolerability of prophylactic agents Pregnancy and Childbirth
Conditions
Interventions
Patient recruitment will take place in antenatal or labour ward of UMMC. All women admitted for a planned vaginal birth will be assessed for eligibility. A Patient Information Sheet will be provided.
Sponsors
University Malaya Medical Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Expecting a vaginal delivery 2. Age 18-45 years 3. Term gestation (=37weeks) 4. Single fetus 5. Cephalic presentation 6. Parity <5 7. Final inclusion for randomization: have achieved vaginal delivery
Exclusion criteria
Exclusion criteria: 1. Contraindication to oxytocin, misoprostol and ergometrine 2. Known hypertension, cardiovascular, hepatic or hematologic disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One hour after delivery, the presence of: 1. Hypertension (systolic = 140 mmHg and/or diastolic = 90 mmHg) measured using a hospital-grade automated blood pressure device 2. Fever (body temperature = 37.5 0C) measured using a hospital-grade thermometer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Delivery blood loss measured using data collected from participant electronic medical records (EMR) at hospital discharge 2. Use of additional haemostatic intervention (e.g., uterotonics, operative interventions) measured using data collected from EMR at hospital discharge 3. Transfer for a higher level of care (HDU or ICU) measured using data collected from EMR at hospital discharge 4. Blood transfusion measured using data collected from EMR at hospital discharge 5. Women's sense of wellbeing measured using a 0-10 Numerical Rating Scale (NRS) before hospital discharge 6. Satisfaction with the allocated intervention measured using a 0-10 NRS) before hospital discharge 7. Interval to first satisfactory breastfeeding (from maternal perspective); date and time as reported by mother as soon as satisfactory breastfeeding episode achieved 8. Shock ascertained measured using data collected from EMR at hospital discharge 9. Coagulopathy measured using data collected from EMR at hospital discharge 10. Hysterectomy measured using data collected from EMR at hospital discharge 11. Organ dysfunction measured using data collected from EMR at hospital discharge 12. Maternal death measured using data collected from EMR at hospital discharge 13. Adverse effects of hypertension, fever, vomiting, shivering, epigastric discomfort or fullness, diarrhoea, headache, chest pain, palpitation, and shortness of breath measured using data collected through direct questioning within 24 hours of birth and from EMR 14. Composite adverse effects of at least one of hypertension, fever, vomiting, shivering, epigastric discomfort or fullness, diarrhoea, headache, chest pain, palpitation, and shortness of breath measured using data collected from EMR at hospital discharge 15. Major harm measured using data collected from EMR at hospital discharge: 15.1. Haemorrhagic cerebral vascular event due to hypertension 15.2. Maternal febrile convulsion 15.3. Maternal ICU admission for bleeding complic | — |
Countries
Malaysia
Contacts
Public ContactHemavahthy;Dr Tan Peng Mani;Chiong
;
Outcome results
None listed