Clinical trial NCT05532215: Sublingual Misoprostol in Reduction of Caesarean Blood Loss
Official title: Comparison Between Adjunctive Sublingual Misoprostol Versus Adjunctive Placebo in the Reduction of Intraoperative Blood Loss During Caesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Partum Hemorrhage
Lead sponsor: Federal Medical Centre, Yenagoa
Sponsor class: OTHER_GOV
First posted: 2022-09-08
Enrollment: 152
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Estimated volume of intraoperative blood loss
timeFrame: Immediate postoperative period
Secondary outcomes:
measure: Additional intraoperative oxytocic
timeFrame: From intraoperative administration of the study intervention till 4 hours postoperative
measure: Postoperative blood transfusion
timeFrame: From intraoperative administration of the study intervention till 48 hours postoperative
measure: Side effect profile
timeFrame: From intraoperative administration of the study intervention till 4 hours postoperative
measure: Postoperative haematocrit level
timeFrame: At 48 hours postoperative
Other outcomes:
Locations:
city: Yenagoa
country: Nigeria
facility: Federal Medical Centre Yenagoa
state: Bayelsa
Study officials:
affiliation: Department of Obstetrics and Gynaecology, Federal Medical Centre, Yenagoa
name: Stanley E Ozori
role: PRINCIPAL_INVESTIGATOR
References: