Postpartum haemorrhage following vaginal delivery Pregnancy and Childbirth Postpartum haemorrhage following vaginal delivery
Conditions
Interventions
Participants will be randomised into one of two study arms:
Arm one: Participants will receive 1ml 10IU oxytocin intramuscularly and 1ml 0.9% normal saline as placebo intravenously im
Sponsors
Coombe Women and Infants University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18 or over 2. Female participants only 3. Singleton pregnancy at more than 36 weeks gestation 4. Those anticipated to have a vaginal delivery
Exclusion criteria
Exclusion criteria: 1. Women who opted for physiological management of the third stage of labour 2. Those who have an antenatal decision for 40IU oxytocin infusion prophylactically following a vaginal delivery 3. Those whom the clinician has a preferred route of administering prophylactic oxytocin for the third stage of labour 4. Those who are deemed to be at risk of postpartum haemorrhage - Previous history of atonic primary postpartum haemorrhage, multiple fibroids, coagulation disorders, thrombocytopenia and receiving anticoagulants 5. Those with previous cardiovascular disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of primary postpartum haemorrhage (> 500ml) following intramuscular oxytocin compared with intravenous oxytocin is determined by reviewing participant’s medical notes and data collected in a case report form (CRF) 24 hours post-delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of side effects following administration of oxytocin (headache, vomiting) is determined by reviewing an observation sheet that the attending midwife are required to fill within 30 minutes of delivery and oxytocin administration. The vital signs which are taken after delivery and prior to transfer to the postnatal ward are recorded in the medical notes. Occurrence of hypotension, tachycardia are recorded in the CRF by reviewing the medical notes. 2. Estimated mean blood loss and early lochial loss is determined by reviewing participant’s medical notes 3. Incidence of major obstetric haemorrhage (measured blood loss = 1000ml) is determined by reviewing participant’s medical notes 24 hours post-delivery 4. Objective change in haemoglobin and haematocrit is measured using a full blood count before delivery and 24 hours after delivery 5. Incidence of severe anaemia (Hb fall = 20%) is measured using a full blood count before delivery and 24 hours after delivery 6. Need for blood transfusion and/or blood products is determined by reviewing the participant’s medical notes 24 hours post-delivery 7. Postnatal length of stay in labour ward/HDU and in the hospital is determined by reviewing participant’s medical notes 8. Need for an additional uterotonic agent between the two groups is determined by reviewing the participant’s medical notes 24 hours post-delivery | — |
Countries
Ireland
Contacts
Public ContactNita Adnan
Outcome results
None listed