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Sublingual Misoprostol in Reduction of Caesarean Blood Loss (SUMIROCBLOL)

Primary Purpose

Post Partum Hemorrhage

Status
Recruiting
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Misoprostol
Oxytocin
Sponsored by
OZORI EBIOGBO STANLEY
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Federal Medical Centre YenagoaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Misoprostol

Placebo

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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 %)
Side effect profile
Side effect including nausea, vomiting, fever, and shivering
Postoperative haematocrit level
48 hours postoperative haematocrit level

Full Information

First Posted
September 4, 2022
Last Updated
April 11, 2023
Sponsor
OZORI EBIOGBO STANLEY
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1. Study Identification

Unique Protocol Identification Number
NCT05532215
Brief Title
Sublingual Misoprostol in Reduction of Caesarean Blood Loss
Acronym
SUMIROCBLOL
Official Title
Comparison Between Adjunctive Sublingual Misoprostol Versus Adjunctive Placebo in the Reduction of Intraoperative Blood Loss During Caesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2023 (Actual)
Primary Completion Date
October 14, 2023 (Anticipated)
Study Completion Date
November 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
OZORI EBIOGBO STANLEY

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A hospital's pharmacist/pharmacologist will manufacture the misoprostol tablets at doses of 200 mcg each as well as the placebo tablets (which will contain vitamin B complex excipient only). The misoprostol tablets and placebo tablets will be indistinguishable. Envelopes will be pre-packed, sealed and outwardly labelled by a hospital's pharmacist/pharmacologist who will take no further part in the study. Each pre-packed envelope will contain three 200 mcg misoprostol tablets for the misoprostol arm or three placebo tablets (which will contain vitamin B complex excipient only) for the placebo arm. The randomization list will be in the possession of a research assistant who will take no further part in the study after randomly allocating the participants to the study arms, till the end of the study.
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Misoprostol
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
The misoprostol tablets to be used in the study will be of the same brand and batch
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
The oxytocin ampoules to be used in the study will be of the same brand and batch
Primary Outcome Measure Information:
Title
Estimated volume of intraoperative blood loss
Description
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
Secondary Outcome Measure Information:
Title
Additional intraoperative oxytocic
Description
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
Title
Postoperative blood transfusion
Description
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
Title
Side effect profile
Description
Side effect including nausea, vomiting, fever, and shivering
Time Frame
From intraoperative administration of the study intervention till 4 hours postoperative
Title
Postoperative haematocrit level
Description
48 hours postoperative haematocrit level
Time Frame
At 48 hours postoperative

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stanley E Ozori
Phone
+2348065876000
Email
ozoriniseod@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley E Ozori
Organizational Affiliation
Department of Obstetrics and Gynaecology, Federal Medical Centre, Yenagoa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Medical Centre Yenagoa
City
Yenagoa
State/Province
Bayelsa
ZIP/Postal Code
560231
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EBIOGBO S OZORI, FWACS
Phone
2348065876000
Email
ozoriniseod@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Sublingual Misoprostol in Reduction of Caesarean Blood Loss

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