Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 200 micrograms of Misoprostol applied sublingually together with standard parenteral oxytocic therapy |
|
| Placebo | Placebo Comparator | 200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy micrograms of misoprostol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 200 micrograms of misoprostol | Drug | 200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carole Rattray, DM | Contact | 876.927.1145 | carole.rattray@uwimona.edu.jm | |
| Peta-Gaye Thomas Brown, PhD | Contact | 876.927.2556 | petagaye.thomas03@uwimona.edu.jm |
| Name | Affiliation | Role |
|---|---|---|
| Rattray Dr Carole | University of the West Indies Mona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of the West Indies, Mona | Recruiting | Kingston | Kgn 7 | Jamaica |
Not provided
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Prospective cohort
Not provided
Not provided
Double Blind Randomised Control Trial
| Placebo Oral Tablet | Drug | 200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy |
|
| 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 |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |