The Carboprost or Oxytocin Postpartum haemorrhage Effectiveness Study.
Phase 1
- Conditions
- Primary postpartum haemorrhageMedDRA version: 21.1Level: LLTClassification code 10055323Term: Postpartum hemorrhage (primary)System Organ Class: 100000004868Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
- Registration Number
- EUCTR2018-001829-11-GB
- Lead Sponsor
- niversity of Liverpool
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 3948
Inclusion Criteria
= 16 years of age
Requirement for medical treatment for primary PPH
Are the trial subjects under 18? yes
Number of subjects for this age range: 198
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 3750
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Known to have opted out of participation antenatally
Known oxytocin or carboprost hypersensitivity
Known active cardiac or pulmonary disease
Known to have previously been treated as part of COPE
Has already received carboprost prophylactically for postpartum haemorrhage
Has already received uterotonic drug treatment for postpartum haemorrhage (this does not include PPH prophylaxis)
Stillbirth
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare carboprost with oxytocin as initial treatments for women with clinically diagnosed PPH after giving birth in UK hospitals.;Secondary Objective: 1. To assess the relative cost-effectiveness of the use of carboprost and oxytocin as first line treatments for women with clinically diagnosed primary PPH.<br>2. To explore the views of participants and their carers about their experiences of the two treatments and the consent process;Primary end point(s): Blood transfusion defined as any blood transfusion or cell salvage of = 300mls starting within 48 hour of birth.;Timepoint(s) of evaluation of this end point: 48 hours or hospital discharge (if earlier than 48 hours).
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Volume of blood transfusion<br>2. User of a further uterotonic drug<br>3. Composite outcome of any organ dysfunction based on WHO near-miss approach for maternal health<br>4. Hysterectomy<br>5. Blood loss<br>6. Blood loss = 1000 mls<br>7. Haemoglobin<br>8. Shock<br>9. Maternal death<br>10. Non pharmacological approach to treat or investigate bleeding<br>11. Manual removal of placenta<br>12. Any adverse reactions of the intervention for the mother<br>13. ‘Skin to skin’ care with baby within the first hour after birth<br>14. Separation from new-born in first hour after birth<br>15. Breastfeeding<br>16. Childbirth Experience Questionnaire (CEQ)<br>17. Resource use;Timepoint(s) of evaluation of this end point: At 24 hrs, 48 hrs (or hospital discharge if sooner) and 4 weeks