An interventional study of Misoprostol and Oxytocin in Post Partum Hemorrhage, sponsored by OZORI EBIOGBO STANLEY. Status unknown at 1 site in Nigeria. Open to female participants. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by OZORI EBIOGBO STANLEY · Not applicable, Interventional, and Prevention
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.
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.
456 studies on the registry are indexed under Postpartum Hemorrhage; 77 are open to participants now.
This study's planned enrollment of 152 is close to the median of 148 across 348 interventional studies indexed under Postpartum Hemorrhage.
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Exclusion Criteria:
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.
Drug: Misoprostol · Drug: Oxytocin
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.
Drug: Oxytocin
The misoprostol tablets to be used in the study will be of the same brand and batch
The oxytocin ampoules to be used in the study will be of the same brand and batch
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
Time frame: Immediate postoperative period
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.
Time frame: From intraoperative administration of the study intervention till 4 hours postoperative
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 %)
Time frame: From intraoperative administration of the study intervention till 48 hours postoperative
Side effect profile
Side effect including nausea, vomiting, fever, and shivering
Time frame: From intraoperative administration of the study intervention till 4 hours postoperative
Postoperative haematocrit level
48 hours postoperative haematocrit level
Time frame: At 48 hours postoperative
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Misoprostol