Cesarean Section ComplicationsNCT03777696
Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery
A study testing Misoprostol and TA in people with Cesarean Section Complications, run by hany farouk at 1 site in Egypt.
Trial summary
Purpose to evaluate the effects of buccal misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women undergoing emergent 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 TA
- 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
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 31 Jan 2021
- 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
- age >18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor
Who cannot join
- multiple gestations
- placenta praevia and placental abruption
- undergoing cesarean section with general anesthesia
- women undergoing cesarean section at less than 37 weeks of gestation--with a severe medical disorder
- allergy to tranexamic acid or misoprostol
- refuse to consent
- elective cesarean section
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: A Randomized Controlled Trial Comparing Co-administered Buccal Misoprostol and Intravenous Tranexamic Acid, Versus Buccal Misoprostol Alone for the Prevention of Postpartum Hemorrhage Following an Emergent Cesarean Delivery
Purpose to evaluate the effects of buccal misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women undergoing emergent cesarean section
Read the detailed description
The American Congress of Obstetricians and Gynecologists (ACOG) defines postpartum hemorrhage (PPH) as the loss of more than 1,000 mL after cesarean delivery. In the majority of cases, uterine atony is responsible for the occurrence of excessive bleeding during or following childbirth. The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond the investigator reach unless prioritize the prevention and treatment of PPH in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) has become essential to diminish the risk of PPH and improve maternal safety. Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer. Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CS has not been investigated as much.T he buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration. 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 PPH in females after vaginal or elective CS. The investigators designed this study to evaluate and compare these two new therapeutic options in controlling PPH following emergent CS.
- Conditions
- Cesarean Section Complications
- Being tested
- Misoprostol, TA, placebo to misoprostol, placebo to TA
- Keywords
- cesarean section, tranexamic acid, postpartum hemorrhage, misoprostol
- 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
Also called Active Comparator
400 μg of buccal misoprostol
TADrug
Also called active comparator
1 gm of tranexamic acid in 100 ml saline iv
placebo to misoprostolDrug
Also called Placebo comparator
placebo tablets to misoprostol buccal
placebo to TADrug
Also called placebo comparator
110 ml saline iv
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol with TA | Active comparator | 400 μg of buccal misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout Receives: Drug: Misoprostol; Drug: TA |
| Misoprostol with placebo to TA | Active comparator | 400 μg of buccal misoprostol (two tablets) plus 110 ml saline by iv rout Receives: Drug: Misoprostol; Drug: placebo to TA |
| placebo to Misoprostol and TA | Placebo comparator | placebo to misoprostol plus placebo to tranexamic acid Receives: Drug: TA; Drug: placebo to misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimation of intraoperative blood loss (ml)
measure Intraoperative blood loss in ml by gravimetric methods
Measured: during the operation
Secondary outcomes (2)
amount of postoperative blood loss
measure amount of blood loss post operative in ml by gravimetric methods
Measured: 6 hours post operative
number of patient with postpartum hemorrhage
calculation of the number of the patients with blood loss >1000 ml
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Jan 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (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
- A Double-Blind Randomized Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- hany farouk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777696
- Sponsor's protocol ID
- aswu /185/18
- Status last verified
- Feb 2019
- First submitted
- 14 Dec 2018
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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
- A Randomized Controlled Trial Comparing Co-administered Buccal Misoprostol and Intravenous Tranexamic Acid, Versus Buccal Misoprostol Alone for the Prevention of Postpartum Hemorrhage Following an Emergent Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03777696
- Acronym / sponsor ID
- aswu /185/18
- Conditions
- Cesarean Section Complications
- Keywords
- cesarean section, tranexamic acid, postpartum hemorrhage, misoprostol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- hany faroukUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 17 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 evaluate the effects of buccal misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women undergoing emergent cesarean section
Detailed description
The American Congress of Obstetricians and Gynecologists (ACOG) defines postpartum hemorrhage (PPH) as the loss of more than 1,000 mL after cesarean delivery. In the majority of cases, uterine atony is responsible for the occurrence of excessive bleeding during or following childbirth. The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond the investigator reach unless prioritize the prevention and treatment of PPH in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) has become essential to diminish the risk of PPH and improve maternal safety. Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer. Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CS has not been investigated as much.T he buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration. 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 PPH in females after vaginal or elective CS. The investigators designed this study to evaluate and compare these two new therapeutic options in controlling PPH following emergent CS.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A Double-Blind Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Misoprostol with TA | Active comparator | Drug: Misoprostol, Drug: TA400 μg of buccal misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout |
| Misoprostol with placebo to TA | Active comparator | Drug: Misoprostol, Drug: placebo to TA400 μg of buccal misoprostol (two tablets) plus 110 ml saline by iv rout |
| placebo to Misoprostol and TA | Placebo comparator | Drug: TA, Drug: placebo to misoprostolplacebo to misoprostol plus placebo to tranexamic acid |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age >18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor
Key exclusion criteria (7 listed)
- multiple gestations
- placenta praevia and placental abruption
- undergoing cesarean section with general anesthesia
- women undergoing cesarean section at less than 37 weeks of gestation--with a severe medical disorder
- allergy to tranexamic acid or misoprostol
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 Comparator400 μg of buccal misoprostol | Drug | Misoprostol with TA, Misoprostol with placebo to TA |
| TAAlso: active comparator1 gm of tranexamic acid in 100 ml saline iv | Drug | Misoprostol with TA, placebo to Misoprostol and TA |
| placebo to misoprostolAlso: Placebo comparatorplacebo tablets to misoprostol buccal | Drug | placebo to Misoprostol and TA |
| placebo to TAAlso: placebo comparator110 ml saline iv | Drug | Misoprostol with placebo to TA |
Primary outcome
estimation of intraoperative blood loss (ml)
Time frame: during the operation
measure Intraoperative blood loss in ml by gravimetric methods
2 secondary outcomes
amount of postoperative blood loss
Time frame: 6 hours post operative
number of patient with postpartum hemorrhage
Time frame: 24 hours post operative
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 TA in people with Cesarean Section Complications, run by hany farouk 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 1 inclusion and 7 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. 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 hany f sallam, md (01022336052, 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?
estimation of intraoperative blood loss (ml) (time frame: during the operation). 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.