Cesarean Section ComplicationsNCT03777878
Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid During Cesarean Section
A study testing Carbetocin, oxytocin and TA in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Purpose to evaluates the effects of oxytocin infusion with or without intravenous tranexamic acid (TA) in comparison with Carbetocin for prevention of postpartum hemorrhage at a cesarean section with one or more risk factor for postpartum hemorrhage. 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?
- Carbetocin, oxytocin and TA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 May 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
- Women who undergo elective cesarean section with one or more risk factors for PPH were the candidates for participation
- With fetal macrosomia, polyhydramnios, low insertion of the placenta, multiple gestations, prolonged labor, chorioamnionitis, past history of PPH, diabetes and high parity (5 previous deliveries).
Who cannot join
- suspected coagulopathy,
- history of coronary artery disease or hypertension,
- women with a history of hypersensitivity to carbetocin, TA or oxytocin
- general anesthesia, and
- PPH due to causes other than uterine atony.
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: Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section: A Double-Blind Randomized Clinical Trial
Purpose to evaluates the effects of oxytocin infusion with or without intravenous tranexamic acid (TA) in comparison with Carbetocin for prevention of postpartum hemorrhage at a cesarean section with one or more risk factor for postpartum hemorrhage.
Read the detailed description
Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries. The risk of PPH is much higher for women undergoing cesarean delivery (CD). Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as a single-dose injection; intravenously administered carbetocin has a half-life of approximately 40 min.
A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min and persists for an average of 60 min following injection.
The aim of this study is to compare the effectiveness of combined tranexamic acid (TA) and oxytocin infusion with intravenous carbetocin for prevention of PPH in patients with risk factors during cesarean section.
- Conditions
- Cesarean Section Complications
- Being tested
- Carbetocin, oxytocin, TA, placebo to carbetocin, placebo to TA
- Keywords
- cesarean section, tranexamic acid, oxytocin, carbetocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Active Comparator
100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
oxytocinDrug
Also called Active Comparator
20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
TADrug
Also called active comparator
2 ampoules of TA in 100 ml saline by slow infusion
placebo to carbetocinDrug
Also called placebo comparator
placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
placebo to TADrug
Also called placebo comparator
2 placebo ampoules to TA in 100 ml saline by slow infusion
placebo to oxytocinDrug
Also called placebo comparator
two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
| Study group | Role | What they receive |
|---|---|---|
| Carbetocin plus placebo to TA and placebo to oxytocin | Active comparator | 100 μg carbetocin ampoule or separate placebo ampoule was diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby plus two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion Receives: Drug: Carbetocin; Drug: placebo to TA; Drug: placebo to oxytocin |
| oxytocin plus TA | Active comparator | 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 1gm TA in 100ml saline by slow infusion plus placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby Receives: Drug: oxytocin; Drug: TA; Drug: placebo to carbetocin |
| oxytocin plus placebo to TA and placebo to carbetocin | Active comparator | 20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion plus placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby Receives: Drug: oxytocin; Drug: placebo to carbetocin; Drug: placebo to TA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of the patient need of additional pharmacological uterotonic.
calculate the number of the patient need of additional pharmacological uterotonic.
Measured: 24 hours post operative
Secondary outcomes (3)
estimation of intraoperative blood loss (ml)
measure Intraoperative blood loss in ml by gravimetric methods
Measured: during the operation
amount of postoperative blood loss
measure amount of blood loss post operative in ml by gravimetric methods
Measured: 24 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 completion30 Mar 2021 (estimated)
- Study completion1 May 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
- 400 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777878
- Sponsor's protocol ID
- aswu/186/18
- Status last verified
- Feb 2019
- First submitted
- 14 Dec 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin Versus Oxytocin Infusion Plus Tranexamic Acid for Prevention of Postpartum Hemorrhage at Cesarean Section: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03777878
- Acronym / sponsor ID
- aswu/186/18
- Conditions
- Cesarean Section Complications
- Keywords
- cesarean section, tranexamic acid, oxytocin, carbetocin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 1 May 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 evaluates the effects of oxytocin infusion with or without intravenous tranexamic acid (TA) in comparison with Carbetocin for prevention of postpartum hemorrhage at a cesarean section with one or more risk factor for postpartum hemorrhage.
Detailed description
Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries. The risk of PPH is much higher for women undergoing cesarean delivery (CD). Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. Carbetocin is a long-acting synthetic analog of oxytocin that can be administered as a single-dose injection; intravenously administered carbetocin has a half-life of approximately 40 min.
A single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min and persists for an average of 60 min following injection.
The aim of this study is to compare the effectiveness of combined tranexamic acid (TA) and oxytocin infusion with intravenous carbetocin for prevention of PPH in patients with risk factors during cesarean section.
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 |
|---|---|---|
| Carbetocin plus placebo to TA and placebo to oxytocin | Active comparator | Drug: Carbetocin, Drug: placebo to TA, Drug: placebo to oxytocin100 μg carbetocin ampoule or separate placebo ampoule was diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby plus two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion |
| oxytocin plus TA | Active comparator | Drug: oxytocin, Drug: TA, Drug: placebo to carbetocin20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 1gm TA in 100ml saline by slow infusion plus placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby |
| oxytocin plus placebo to TA and placebo to carbetocin | Active comparator | Drug: oxytocin, Drug: placebo to carbetocin, Drug: placebo to TA20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby plus 2 placebo ampoules to TA in 100 ml saline by slow infusion plus placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby |
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 undergo elective cesarean section with one or more risk factors for PPH were the candidates for participation
- With fetal macrosomia, polyhydramnios, low insertion of the placenta, multiple gestations, prolonged labor, chorioamnionitis, past history of PPH, diabetes and high parity (5 previous deliveries).
Key exclusion criteria (5 listed)
- suspected coagulopathy,
- history of coronary artery disease or hypertension,
- women with a history of hypersensitivity to carbetocin, TA or oxytocin
- general anesthesia, and
- PPH due to causes other than uterine atony.
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 |
|---|---|---|
| CarbetocinAlso: Active Comparator100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby | Drug | Carbetocin plus placebo to TA and placebo to oxytocin |
| oxytocinAlso: Active Comparator20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby | Drug | oxytocin plus TA, oxytocin plus placebo to TA and placebo to carbetocin |
| TAAlso: active comparator2 ampoules of TA in 100 ml saline by slow infusion | Drug | oxytocin plus TA |
| placebo to carbetocinAlso: placebo comparatorplacebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby | Drug | oxytocin plus TA, oxytocin plus placebo to TA and placebo to carbetocin |
| placebo to TAAlso: placebo comparator2 placebo ampoules to TA in 100 ml saline by slow infusion | Drug | Carbetocin plus placebo to TA and placebo to oxytocin, oxytocin plus placebo to TA and placebo to carbetocin |
| placebo to oxytocinAlso: placebo comparatortwo placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby | Drug | Carbetocin plus placebo to TA and placebo to oxytocin |
Primary outcome
The number of the patient need of additional pharmacological uterotonic.
Time frame: 24 hours post operative
calculate the number of the patient need of additional pharmacological uterotonic.
3 secondary outcomes
estimation of intraoperative blood loss (ml)
Time frame: during the operation
amount of postoperative blood loss
Time frame: 24 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 15 Feb 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbetocin, oxytocin and TA 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 15 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of the patient need of additional pharmacological uterotonic. (time frame: 24 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 15 Feb 2019.