A Phase 3 interventional study of 200 micrograms of misoprostol and Placebo Oral Tablet in Postpartum Hemorrhage, sponsored by The University of The West Indies. Status unknown at 1 site in Jamaica. Open to female participants aged 16 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-05.
Sponsored by The University of The West Indies · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy
Drug: 200 micrograms of misoprostol
200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol
Drug: Placebo Oral Tablet
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
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
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
This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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The University of The West Indies