Post Partum HemorrhageNCT03870256
Oral Tranexamic Acid Plus Sublingual Misoprostol in Atonic Postpartum Hemorrhage
A study testing misoprostol, Carbetocin and TA in people with Post Partum Hemorrhage, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- misoprostol, Carbetocin and TA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 1 Sep 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.
Who cannot join
- were gestational age<37 weeks,
- genital tract trauma,
- coagulation defect,
- women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
- known hypersensitivity to carbetocin or oxytocin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Tranexamic Acid Plus, Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery
Read the detailed description
Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.
- Conditions
- Post Partum Hemorrhage
- Being tested
- misoprostol, Carbetocin, TA
- Keywords
- Postpartum Hemorrhage, vaginal delivery, tranexamic acid, 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
Patient receive 600mic gm sublingual misoprostol
CarbetocinDrug
Also called Active Comparator
Patient receive 100 mic gm carbetocin IV
TADrug
Also called Active Comparator
The patient receives 1gm oral tranexamic acid
| Study group | Role | What they receive |
|---|---|---|
| TA plus misoprostol | Active comparator | Patient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm Receives: Drug: misoprostol; Drug: TA |
| Carbetocin | Active comparator | Patient receives 100 mic gm carbetocin IV Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of blood loss
the amount of blood loss by gm calculated by gravimetric methods
Measured: 6 hours post delivery
Secondary outcomes (2)
number of patients loss more than 1000 ml blood
calculate number of patients loss more than 1000 ml blood
Measured: 24 hours post delivery
need of uterotonics
number of patients need of uterotonics
Measured: 24 hours post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Aug 2021
- Study completion1 Sep 2021
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a prospective double-blind randomized study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (actual)
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 allam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870256
- Sponsor's protocol ID
- aswu/200/19
- Status last verified
- Sep 2021
- First submitted
- 8 Mar 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Tranexamic Acid Plus, Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03870256
- Acronym / sponsor ID
- aswu/200/19
- Conditions
- Post Partum Hemorrhage
- Keywords
- Postpartum Hemorrhage, vaginal delivery, tranexamic acid, misoprostol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 12 Mar 2019 (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.
The aim of the study is to evaluate the effect of oral tranexamic acid plus, sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH) after vaginal delivery
Detailed description
Uterine atony is the main cause of PPH; therefore, active management of the third stage of labor has emerged as a most actual tool in its prevention. The previous study in Egypt recorded that 88% of deaths from PPH occur within 4 h of delivery. Tranexamic acid (TA) is an antifibrinolytic agent that blocks the lysine-binding site of plasminogen to fibrin. Accordingly, clot breaks down, fibrinolysis is inhibited, and excessive bleeding is reduced. In previous studies, its safety has been confirmed for use in non-pregnant women, with no thromboembolic complications. TA is an inexpensive, widely available medicine that has been shown to reduce bleeding in surgery and reduce the risk of death in bleeding trauma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was a prospective double-blind randomized study
| Arm | Type | Receives |
|---|---|---|
| TA plus misoprostol | Active comparator | Drug: misoprostol, Drug: TAPatient receive 600mic gm sublingual misoprostol plus oral tranexamic acid 1 gm |
| Carbetocin | Active comparator | Drug: CarbetocinPatient receives 100 mic gm carbetocin IV |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation.
Key exclusion criteria (5 listed)
- were gestational age<37 weeks,
- genital tract trauma,
- coagulation defect,
- women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
- known hypersensitivity to carbetocin or oxytocin.
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 comparatorPatient receive 600mic gm sublingual misoprostol | Drug | TA plus misoprostol |
| CarbetocinAlso: Active ComparatorPatient receive 100 mic gm carbetocin IV | Drug | Carbetocin |
| TAAlso: Active ComparatorThe patient receives 1gm oral tranexamic acid | Drug | TA plus misoprostol |
Primary outcome
the amount of blood loss
Time frame: 6 hours post delivery
the amount of blood loss by gm calculated by gravimetric methods
2 secondary outcomes
number of patients loss more than 1000 ml blood
Time frame: 24 hours post delivery
need of uterotonics
Time frame: 24 hours post delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Post Partum 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.
hany f allam, 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, Carbetocin and TA in people with Post Partum Hemorrhage, 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 1 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: finished, as of the sponsor's last update on 29 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the amount of blood loss (time frame: 6 hours post delivery). 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 29 Sep 2021.