Post-partum haemorrhage prevention in Zaria, Nigeria
Conditions
Interventions
Intramuscular Oxytocin and Sublingual Misoprostol
Intramuscular carbetocin and sublingual placebo tablets
Sponsors
Dr. Ogudugu Festus Ayobami O.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women in labour with a singleton pregnancy Gestational age of 37 weeks 0day to 41 weeks 3 days No contraindication to vaginal delivery.
Exclusion criteria
Exclusion criteria: Non consenting women Allergy to misoprostol Allergy to carbetocin Allergy to oxytocin Participating in other treatment trials Abruptio placenta placenta previa Coagulopathy Major cardiovascular disorder Major liver disorder Major haematological disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Mean blood loss in the misoprostol-oxytocin arm and carbetocin-only arm of the study at birth and up to 2 hours following vaginal delivery. This will be assessed by measuring the total blood loss (in milliitres) from birth to 2 hours after vaginal delivery. Blood loss will be recorded for each participant, and the group-level analysis will be performed by calculating the mean blood loss for each study arm at the specified time point. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Incidence of postpartum haemorrhage in both arms of the study at birth and up to 24 hours following vaginal delivery. This will involve determining whether each participant had PPH, and the group-level analysis will report the proportion of participants with PPH in each study group. - Percentage fall in haemoglobin concentration in both arms of the study at birth and up to 24 hours following vaginal delivery. Each participant will be measured for the percentage fall in haemoglobin concentration from pre-delivery to 24 hours post-delivery. This will involve calculating the difference between pre-and post-delivery haemoglobin levels, expressed as a percentage, with the mean percentage fall reported for each study arm. - The proportion of women in both arms that will require additional uterotonic(s) and surgical interventions. For each participant, it will be documented if additional interventions were required, and group-level analysis will report the percentage of women needing these interventions. - The proportion of women that will need blood transfusion in both arms of the study within 24 hours post-delivery. The study will document whether each participant required transfusion, with the proportion of transfused participants on each arm. - The proportion of patients with side effects in both arms of the study. This will entail monitoring each participant for side effects, with the group-level analysis reporting the percentage of patients with side effects in each arm. | — |
Countries
Nigeria
Contacts
Public ContactUmma Bawa
Secondary Researcher
Outcome results
None listed