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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,496
200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy
200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy
University Hospital of the West Indies, Mona
Kingston, Jamaica
RECRUITINGVolume 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
Time frame: 24 hours
Comparison of blood loss between intervention and control group
Volume of blood loss at delivery in the control group.
Time frame: 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
Time frame: 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
Time frame: 24 hours
Measurement of Electrolytes (Sodium)
Blood concentration of sodium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Time frame: 24 hours
Measurement of Electrolytes (Potassium)
Blood concentration of potassium (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Time frame: 24 hours
Measurement of Electrolytes (Chloride)
Blood concentration of chloride (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Time frame: 24 hours
Measurement of Electrolytes (Bicarbonate)
Blood concentration of bicarbonate (mmol/L) will be measured on admission in labour compared to 24 hours postpartum
Time frame: 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
Time frame: 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
Time frame: 24 hours
Percentage of participants who receive a hysterectomy as a complication of bleeding will be assessed
Time frame: 24 hours
Percentage of participants who are admitted to the ICU due to complications of bleeding will be assessed
Time frame: 24 hours
Percentage of participants with fever as a complication of misoprostol administration will be assessed
Time frame: 24 hours
Percentage of participants with shivering as a complication of misoprostol administration will be assessed (Shivering)
Time frame: 24 hours
Percentage of participants with nausea as a complication of misoprostol administration will be assessed (Nausea)
Time frame: 24 hours
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