Cesarean Section ComplicationsNCT03774706
Sublingual Misoprostol With or Without Intravenous Tranexamic Acid During Hemorrhagic Cesarean Section
A study testing Misoprostol and Tranexamic Acid in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Misoprostol and Tranexamic Acid
- 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
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 31 Jan 2022
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women who undergone elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
- age between 18 and 45 years, gestational age of 37-40 weeks, singleton pregnancy, CS with inferior segment incision, and spinal anesthesia.
Who cannot join
- having an underlying disease (heart, liver, kidney, pulmonary, etc.),
- eclampsia and severe preeclampsia
- allergy to TA (such as known allergy or thromboembolic event during pregnancy) and misoprostol
- coagulation disorders
- refuse or unable to consent
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, 81528
hany f sallam, md, 01092440504 ext. 002, nahla.elsayed@aswu.ed.eg
Nahla w Shady, md, 1019240504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Role of Sublingual Misoprostol With or Without Intravenous Tranexamic Acid for Reducing Post-partum Hemorrhage During and After Hemorrhagic Cesarean Section: A Double-Blind Randomized Clinical Trial
Purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean section.
Read the detailed description
Different uterotonic agents administration, mainly oxytocin, has been routinely used to reduce the frequency of cesarean section (CS) -related hemorrhage; however, some studies reported that oxytocin use in the setting of CS may result in maternal adverse effects, including hypotension and tachycardia., Therefore, investigating other therapeutic agents with lower adverse effects and higher efficacy is needed. Recently, a number of studies reported a correlation between fibrinogen decrease and cesarean-related hemorrhage. Furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic equilibrium and contributing to bleeding. Therefore, anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of postpartum hemorrhage (PPH) in females after vaginal or elective CS verse effects and higher efficacy is needed. Moreover, misoprostol is a prostaglandin E1 analog which has been introduced as a uterotonic agent for preventing PPH following CS. A recent study reported that oral or sublingual misoprostol is more effective than the placebo in reducing severe PPH, following CS
- Conditions
- Cesarean Section Complications
- Being tested
- Misoprostol, Tranexamic Acid, placebo to tranexamic acid
- Keywords
- cesarean section, tranexamic acid, misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Active Comparator
two tablets misoprostol 400 μg sublingual
Tranexamic AcidDrug
Also called active comparator
two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline
placebo to tranexamic acidDrug
Also called Placebo
placebo to tranexamic acid (110 ml saline)
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol with TA | Active comparator | two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv Receives: Drug: Misoprostol; Drug: Tranexamic Acid |
| Misoprostol with placebo to TA | Active comparator | two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv Receives: Drug: Misoprostol; Drug: placebo to tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients develop postpartum hemorrhage
calculation of number of patients develop postpartum hemorrhage
Measured: 6 hours post operative
Secondary outcomes (1)
intraoperative blood loss (ml)
calculation of the amount of blood loss in ml by gravimetric methods
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Jan 2019
- Primary completion30 Dec 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Model description
- double-blind placebo randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774706
- Sponsor's protocol ID
- aswu/184/18
- Status last verified
- Feb 2019
- First submitted
- 11 Dec 2018
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sublingual Misoprostol With or Without Intravenous Tranexamic Acid for Reducing Post-partum Hemorrhage During and After Hemorrhagic Cesarean Section: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03774706
- Acronym / sponsor ID
- aswu/184/18
- Conditions
- Cesarean Section Complications
- Keywords
- cesarean section, tranexamic acid, misoprostol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 13 Dec 2018 (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.
Purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean section.
Detailed description
Different uterotonic agents administration, mainly oxytocin, has been routinely used to reduce the frequency of cesarean section (CS) -related hemorrhage; however, some studies reported that oxytocin use in the setting of CS may result in maternal adverse effects, including hypotension and tachycardia., Therefore, investigating other therapeutic agents with lower adverse effects and higher efficacy is needed. Recently, a number of studies reported a correlation between fibrinogen decrease and cesarean-related hemorrhage. Furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic equilibrium and contributing to bleeding. Therefore, anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of postpartum hemorrhage (PPH) in females after vaginal or elective CS verse effects and higher efficacy is needed. Moreover, misoprostol is a prostaglandin E1 analog which has been introduced as a uterotonic agent for preventing PPH following CS. A recent study reported that oral or sublingual misoprostol is more effective than the placebo in reducing severe PPH, following CS
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blind placebo randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Misoprostol with TA | Active comparator | Drug: Misoprostol, Drug: Tranexamic Acidtwo tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv |
| Misoprostol with placebo to TA | Active comparator | Drug: Misoprostol, Drug: placebo to tranexamic acidtwo tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women who undergone elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
- age between 18 and 45 years, gestational age of 37-40 weeks, singleton pregnancy, CS with inferior segment incision, and spinal anesthesia.
Key exclusion criteria (5 listed)
- having an underlying disease (heart, liver, kidney, pulmonary, etc.),
- eclampsia and severe preeclampsia
- allergy to TA (such as known allergy or thromboembolic event during pregnancy) and misoprostol
- coagulation disorders
- refuse or unable to consent
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 |
|---|---|---|
| MisoprostolAlso: Active Comparatortwo tablets misoprostol 400 μg sublingual | Drug | Misoprostol with TA, Misoprostol with placebo to TA |
| Tranexamic AcidAlso: active comparatortwo ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline | Drug | Misoprostol with TA |
| placebo to tranexamic acidAlso: Placeboplacebo to tranexamic acid (110 ml saline) | Drug | Misoprostol with placebo to TA |
Primary outcome
number of patients develop postpartum hemorrhage
Time frame: 6 hours post operative
calculation of number of patients develop postpartum hemorrhage
1 secondary outcome
intraoperative blood loss (ml)
Time frame: during the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
hany f sallam, md principal investigator
Aswan University Hospital
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 Tranexamic Acid in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.
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 2 inclusion and 5 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 18 Feb 2019. 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 Egypt. 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. 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 hany f sallam (01022336052 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients develop postpartum hemorrhage (time frame: 6 hours post operative). 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 18 Feb 2019.