Sublingual Misoprostol in Reduction of Caesarean Blood Loss

Post Partum Hemorrhage Clinical Trial

— SUMIROCBLOL  

Official title:

Comparison Between Adjunctive Sublingual Misoprostol Versus Adjunctive Placebo in the Reduction of Intraoperative Blood Loss During Caesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532215
• Other study ID #: FMCY/O&G/SUMIROCBLOL/2022
• Status: Recruiting
• Phase: N/A
• Start date: March 14, 2023
• Est. completion date: November 14, 2023

Study information

• Verified date: April 2023
• Source: Federal Medical Centre, Yenagoa
• Contact: Stanley E Ozori
• Phone: +2348065876000
• Email: ozoriniseod[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Caesarean delivery is inevitably associated with a higher amount of blood loss vis-à-vis primary postpartum haemorrhage, when compared to vaginal delivery. Oxytocin use in tropical developing countries for the reduction blood loss at caesarean section have been met with challenges of ineffectiveness due to poor transportation, inadequate storage and drug adulteration. Therefore, there is a need for an effective, temperature stable uterotonic with a lesser risk of adulteration. The study is aimed at evaluating the effectiveness and safety of adjunctive sublingual misoprostol in reducing intraoperative blood loss at caesarean section.

Description:

It would be a double blind randomized controlled trial. One hundred and fifty-two pregnant women at term who have indications for caesarean section and have risk factors for primary postpartum haemorrhage, as well as meet the eligibility criteria would be randomized equally into two study arms (Misoprostol study arm and Placebo study arm) after informed consent. The Misoprostol study arm will receive 400 mcg of sublingual misoprostol as two 200 mcg misoprostol tablets. The Placebo study arm would receive two sublingual placebo tablets similar to the misoprostol tablets. The Misoprostol and the Placebo tablets will be given in each study arm at the point of starting the uterine incision at caesarean section. Both study arms would receive routine intravenous oxytocin at the time of clamping of the umbilical cord. The outcome measures will be estimated intraoperative blood loss, the need for additional intraoperative oxytocic, blood transfusion, the occurrence of side effects, and incidence of primary postpartum haemorrhage.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: November 14, 2023
• Est. primary completion date: October 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women at term (37+0 weeks to 41+6 weeks gestational age) for elective or non-elective caesarean sections
• Pregnant women who have risk factor for primary postpartum haemorrhage
• Pregnant women who consent to participate in the study

Exclusion Criteria:

• Pregnant women who withhold consent to participate in the study
• Caesarean sections for dire emergencies (umbilical cord prolapse, suspected fetal distress and active antepartum haemorrhage)
• Previous caesarean sections or other uterine surgeries
• Pregnant women with no risk factor for primary postpartum haemorrhage
• Allergy to misoprostol use
• Known history of hepatic, renal and haematological disorders
• Caesarean section to be done under general anaesthesia
• Fever (temperature = 37.5 degrees centigrade)
• Pre-operative anaemia (pre-operative haematocrit level < 30 %)
• Pregnant women who are unconscious or have eclampsia

Related Conditions & MeSH terms

• Hemorrhage
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
The misoprostol tablets to be used in the study will be of the same brand and batch
• Oxytocin
The oxytocin ampoules to be used in the study will be of the same brand and batch

Locations

Country	Name	City	State
Nigeria	Federal Medical Centre Yenagoa	Yenagoa	Bayelsa

Sponsors (1)

Lead Sponsor	Collaborator
OZORI EBIOGBO STANLEY

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated volume of intraoperative blood loss	Intraoperative blood loss would be estimated by standard volumetric and gravimetric methods using standard calibrated suction bottles for the volumetric method and for the gravimetric method; wet weight of the abdominal mops, delivery mats, theatre drapes, theatre gowns and vaginal swabs will be gotten using the Mettler PB 153 weighing scale after its re-calibration. The total estimated intraoperative blood loss (T) will be measured by calculating the sum total of the weights of the blood soaked abdominal mops, vaginal gauzes, theatre drapes, theatre gowns and delivery mat (S) and subtracting the sum total of the dry weights of the used abdominal mops, vaginal gauzes, theatre drapes, theatre gowns and delivery mat (D) as shown in the equation: T = S - D. It will be assumed that 1 ml of blood weighs approximately 1 g	Immediate postoperative period
Secondary	Additional intraoperative oxytocic	Additional intraoperative oxytocic as10 IU oxytocin when there is absence of uterine tone as assessed by the lead surgeon ten minutes after administration of the intervention drug. Intramuscular ergometrine at a dose of 0.5 mg will be used as a second-line additional uterotonic agent where there are no contraindications.	From intraoperative administration of the study intervention till 4 hours postoperative
Secondary	Postoperative blood transfusion	Postoperative blood transfusion indicated by occurrence of primary postpartum haemorrhage (an intraoperative blood loss = 1,000 ml following caesarean section or symptomatic postoperative haematocrit level = 24 %)	From intraoperative administration of the study intervention till 48 hours postoperative
Secondary	Side effect profile	Side effect including nausea, vomiting, fever, and shivering	From intraoperative administration of the study intervention till 4 hours postoperative
Secondary	Postoperative haematocrit level	48 hours postoperative haematocrit level	At 48 hours postoperative