Misoprostol in the Prevention of Postpartum Haemorrhage

Study Overview
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Brief Summary
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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.

Official Title
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Sublingual Misoprostol and Routine Third Stage Prophylaxis for the Prevention of Postpartum Haemorrhage: A Randomised Controlled Clinical Trial.

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Drug: 200 micrograms of misoprostol
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective cohort
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy | Drug: 200 micrograms of misoprostol<br>* 200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy<br>|
| Placebo Comparator: Placebo<br>200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol | Drug: Placebo Oral Tablet<br>* 200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of blood loss at the time of delivery | Volume (ml) of blood loss at the time of delivery will be measured using an under-buttock collection drape | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of blood loss between intervention and control group | Volume of blood loss at delivery in the control group. | 24 hours | 
| Measurement of Haematological indices (Haemoglobin level) | Measurement of haemoglobin level (g/dl) in blood samples obtained on admission in labour compared to 24 hours postpartum | 24 hours | 
| Comparison of Haematological indices (Packed Cell Volume, PCV) | Measurement of the PCV (%) in blood samples obtained on admission in labour compared to 24 hours postpartum | 24 hours | 
| Measurement of Electrolytes (Sodium) | Blood concentration of sodium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum | 24 hours | 
| Measurement of Electrolytes (Potassium) | Blood concentration of potassium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum | 24 hours | 
| Measurement of Electrolytes (Chloride) | Blood concentration of chloride (mmol/L) will be measured on admission in labour compared to 24 hours postpartum | 24 hours | 
| Measurement of Electrolytes (Bicarbonate) | Blood concentration of bicarbonate (mmol/L) will be measured on admission in labour compared to 24 hours postpartum | 24 hours | 
| Cardiovascular instability - Frequency of hypotension as a complication of bleeding | 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 | 24 hours | 
| Cardiovascular instability - Frequency of tachycardia as a complication of bleeding | 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 | 24 hours | 
| Percentage of participants who receive a hysterectomy as a complication of bleeding will be assessed |  | 24 hours | 
| 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 |