Post Partum HemorrhageSUMIROCBLOLNCT05532215
Sublingual Misoprostol in Reduction of Caesarean Blood Loss
A study testing Misoprostol and Oxytocin in people with Post Partum Hemorrhage, run by OZORI EBIOGBO STANLEY at 1 site in Nigeria.
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Misoprostol and Oxytocin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteNigeria
- Study dates
- 14 Mar 2023to 14 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Federal Medical Centre Yenagoa
Yenagoa, Bayelsa State, 560231
EBIOGBO S OZORI, FWACS, 2348065876000, ozoriniseod@yahoo.com
About this study
Official title: Comparison Between Adjunctive Sublingual Misoprostol Versus Adjunctive Placebo in the Reduction of Intraoperative Blood Loss During Caesarean Section
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.
Read the 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.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Misoprostol, Oxytocin
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
The misoprostol tablets to be used in the study will be of the same brand and batch
OxytocinDrug
The oxytocin ampoules to be used in the study will be of the same brand and batch
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | 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. Receives: Drug: Misoprostol; Drug: Oxytocin |
| Placebo | Placebo comparator | 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. Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediate postoperative period
Secondary outcomes (4)
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.
Measured: 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 %)
Measured: From intraoperative administration of the study intervention till 48 hours postoperative
Side effect profile
Side effect including nausea, vomiting, fever, and shivering
Measured: From intraoperative administration of the study intervention till 4 hours postoperative
Postoperative haematocrit level
48 hours postoperative haematocrit level
Measured: At 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start14 Mar 2023
- Primary completion14 Oct 2023 (estimated)
- Study completion14 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OZORI EBIOGBO STANLEY
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, OZORI EBIOGBO STANLEY, Federal Medical Centre, Yenagoa
- Investigators
- Stanley E Ozori, Principal investigator, Department of Obstetrics and Gynaecology, Federal Medical Centre, Yenagoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532215
- Sponsor's protocol ID
- FMCY/O&G/SUMIROCBLOL/2022
- Acronym
- SUMIROCBLOL
- Status last verified
- Apr 2023
- First submitted
- 4 Sep 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Adjunctive Sublingual Misoprostol Versus Adjunctive Placebo in the Reduction of Intraoperative Blood Loss During Caesarean Section
- ClinicalTrials.gov ID
- NCT05532215
- Acronym / sponsor ID
- SUMIROCBLOL / FMCY/O&G/SUMIROCBLOL/2022
- Conditions
- Post Partum Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- OZORI EBIOGBO STANLEYOther government
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 14 Oct 2023 (estimated)
- Study completion
- 14 Nov 2023 (estimated)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: Misoprostol, Drug: Oxytocin400 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. |
| Placebo | Placebo comparator | Drug: OxytocinTwo 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolThe misoprostol tablets to be used in the study will be of the same brand and batch | Drug | Misoprostol |
| OxytocinThe oxytocin ampoules to be used in the study will be of the same brand and batch | Drug | Misoprostol, Placebo |
Primary outcome
Estimated volume of intraoperative blood loss
Time frame: Immediate postoperative period
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
4 secondary outcomes
Additional intraoperative oxytocic
Time frame: From intraoperative administration of the study intervention till 4 hours postoperative
Postoperative blood transfusion
Time frame: From intraoperative administration of the study intervention till 48 hours postoperative
Side effect profile
Time frame: From intraoperative administration of the study intervention till 4 hours postoperative
Postoperative haematocrit level
Time frame: At 48 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Yes
Related trials for Post Partum Hemorrhage
Not yet recruiting
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Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanley E Ozori principal investigator
Department of Obstetrics and Gynaecology, Federal Medical Centre, Yenagoa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol and Oxytocin in people with Post Partum Hemorrhage, run by OZORI EBIOGBO STANLEY at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stanley E Ozori (+2348065876000, ozoriniseod@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated volume of intraoperative blood loss (time frame: Immediate postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.