Sublingual Misoprostol in Reduction of Caesarean Blood Loss (SUMIROCBLOL)

OZORI EBIOGBO STANLEY

Status: Enrolling

Conditions: Post Partum Hemorrhage

Treatments: Drug: Oxytocin; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT05532215

FMCY/O&G/SUMIROCBLOL/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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152 participants in 2 patient groups, including a placebo group

Misoprostol

Experimental group

Description:

400 mcg of sublingual misoprostol as two 200 mcg misoprostol tablets at the point of starting the uterine incision at caesarean section, then bolus administration of 10 IU of intravenous oxytocin followed by an infusion of 20 IU of oxytocin in 500 ml of normal saline at a rate of twenty drops per minute to run over eight hours.

Treatment:

Drug: Misoprostol

Drug: Oxytocin

Placebo

Placebo Comparator group

Description:

Two sublingual placebo tablets similar to the misoprostol tablets at the point of starting the uterine incision at caesarean section, then bolus administration of 10 IU of intravenous oxytocin followed by an infusion of 20 IU of oxytocin in 500 ml of normal saline at a rate of twenty drops per minute to run over eight hours.

Treatment:

Drug: Oxytocin