Postpartum Hemorrhage
Conditions
Brief summary
Postpartum haemorrhage is a major contributor to maternal mortality in the developing world. The incidence is between 5 and 12% in Jamaica and varies depending on the route of delivery. Misoprostol is a uterotonic agent which has the potential to augment the effects of the standard parenteral oxytocic agents used as best practice in the active management of the third stage of labour, thereby reducing the risk of postpartum haemorrhage and its attendant complications. The Aim of the study is twofold: to show that this additive effect translates to a reduced postpartum haemorrhage rate and secondly to demonstrate reduced side effects of misoprostol resulting from the lower dose and the powdered sublingual administration.
Interventions
DRUG200 micrograms of misoprostol
200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy
DRUGPlacebo Oral Tablet
200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy
Sponsors
The University of The West Indies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double Blind Randomised Control Trial
Intervention model description
Prospective cohort
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women admitted to the labour wards at University Hospital of the West Indies (UHWI) and Victoria Jubilee Hospital (VJH) undergoing a vaginal delivery * Consent given to participate in the study
Exclusion criteria
* Women undergoing caesarean section * Gestational age less than 28 weeks * Any severe allergic conditions * Severe asthmatics * Age \<16 years * Temperature \>38 degrees Celsius * Women not wishing to consent to join the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of blood loss at the time of delivery | 24 hours | Volume (ml) of blood loss at the time of delivery will be measured using an under-buttock collection drape |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of blood loss between intervention and control group | 24 hours | Volume of blood loss at delivery in the control group. |
| Measurement of Haematological indices (Haemoglobin level) | 24 hours | Measurement of haemoglobin level (g/dl) in blood samples obtained on admission in labour compared to 24 hours postpartum |
| Comparison of Haematological indices (Packed Cell Volume, PCV) | 24 hours | Measurement of the PCV (%) in blood samples obtained on admission in labour compared to 24 hours postpartum |
| Measurement of Electrolytes (Sodium) | 24 hours | Blood concentration of sodium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum |
| Measurement of Electrolytes (Potassium) | 24 hours | Blood concentration of potassium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum |
| Measurement of Electrolytes (Chloride) | 24 hours | Blood concentration of chloride (mmol/L) will be measured on admission in labour compared to 24 hours postpartum |
| Percentage of participants who receive a hysterectomy as a complication of bleeding will be assessed | 24 hours | — |
| Cardiovascular instability - Frequency of hypotension as a complication of bleeding | 24 hours | Presence of hypotension will be assessed as cardiovascular instability due to a complication of bleeding in each participant on admission in labour compared to 24 hours postpartum |
| Cardiovascular instability - Frequency of tachycardia as a complication of bleeding | 24 hours | Presence of tachycardia will be assessed as cardiovascular instability due to a complication of bleeding in each participant on admission in labour compared to 24 hours postpartum |
| Percentage of participants who are admitted to the ICU due to complications of bleeding will be assessed | 24 hours | — |
| Percentage of participants with fever as a complication of misoprostol administration will be assessed | 24 hours | — |
| Percentage of participants with shivering as a complication of misoprostol administration will be assessed (Shivering) | 24 hours | — |
| Percentage of participants with nausea as a complication of misoprostol administration will be assessed (Nausea) | 24 hours | — |
| Measurement of Electrolytes (Bicarbonate) | 24 hours | Blood concentration of bicarbonate (mmol/L) will be measured on admission in labour compared to 24 hours postpartum |
Countries
Jamaica
Contacts
Primary ContactCarole Rattray, DM
Backup ContactPeta-Gaye Thomas Brown, PhD
Outcome results
None listed