Postpartum HemorrhagePhase 4NCT02805426
Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage
A Phase 4 study testing Tranexamic Acid and Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 4 sites in 2 countries.
Trial summary
This study is a randomized, double-blind, placebo controlled trial that will enroll 250 women (125 per study arm). The objective of the study is to determine the efficacy and tolerability of oral tranexamic acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Tranexamic Acid and Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2016to Jan 2018
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women who delivery vaginally
- Women who experience PPH defined as blood loss ≥700ml
- Women capable of giving consent
Who cannot join
- Clear contraindication for tranexamic acid such as known allergy or thromboembolic event during pregnancy
- Women delivering via cesarean section
- Provider feels that the woman, at presentation for delivery, is not in a position to give appropriate informed consent
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Senegal2 sites
Centre de santé 10ème de Thiès
Thiès
Centre hospitalier Régional de Thiès, Ahmadou Sakhir Ndiéguène
Thiès
Vietnam2 sites
National OB-GYN Hospital
Hanoi
Hung Vuong Hospital
Ho Chi Minh City
About this study
Official title: Double-blind, Randomized Controlled Trial to Assess the Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage
This study is a randomized, double-blind, placebo controlled trial that will enroll 250 women (125 per study arm).
The objective of the study is to determine the efficacy and tolerability of oral tranexamic acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH). Women will be diagnosed with postpartum hemorrhage if blood loss reaches 700ml in the calibrated receptacle. If diagnosed with postpartum hemorrhage , the woman will be randomized to receive either tranexamic acid or placebo, both in tablet form. All participants will receive 800 mcg sublingual misoprostol (4 tablets 200mcg each).
The investigators hypothesize that tranexamic acid (in tablet form) as an adjunct to misoprostol will be more effective than misoprostol alone in stopping postpartum bleeding without recourse to further treatment in significantly more women.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Tranexamic Acid, Placebo, 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.
Tranexamic AcidDrug
PlaceboDrug
MisoprostolDrug
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | 1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol Receives: Drug: Tranexamic Acid; Drug: Misoprostol |
| Placebo | Placebo comparator | oral placebo + 800 mcg sublingual misoprostol Receives: Drug: Placebo; Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm
Measured: 20 minutes after initial study treatment
Secondary outcomes (10)
Rate of severe PPH
Rate of severe PPH (>1000 ml total blood loss)
Measured: 2 hours after delivery
Mean/median blood loss
Measured: at two hours after treatment
Proportion of women with controlled bleeding
proportion of women with bleeding controlled at different time intervals (20, 40, 60, 120 mins)
Measured: At various time intervals after study treatment (20, 40, 60, 120 mins)
Use of uterotonic agents after initial treatment
Proportion of women who are given uterotonic agents after initial treatment
Measured: 2 hours after delivery
Proportion of women who received a serious interventions
Serious intervention is defined as blood transfusion, interventions for tissue repair, surgical intervention [including curettage, vacuum aspiration for retained placental tissue, hysterectomy, surgical uterine artery ligature])
Measured: 2 hours after delivery
Proportion of women who received additional drugs
Proportion of women who receive additional drugs
Measured: 2 hours after delivery
Proportion of women who receive additional intervention
Proportion of women who receive additional interventions (i.e. suturing)
Measured: 2 hours after delivery
Adverse events
Proportion of women who experience an adverse event
Measured: 48 hours after delivery
Proportion of women who experience side effects
Proportion of women who experience side effects
Measured: 2 hours after delivery
Proportion of women who find the treatment tolerable
Proportion of women who find the procedure tolerable and acceptable as indicated in an acceptability scale
Measured: 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Research and Consultancy in Reproductive Health
- Responsible party
- Sponsor
- Investigators
- Beverly Winikoff, MD, MPH, Principal investigator, Gynuity Health ProjectsJill Durocher, Principal investigator, Gynuity Health ProjectsDina Abbas, MPH, Principal investigator, Gynuity Health ProjectsNguyen thi Nhu Ngoc, MD, MSc, Principal investigator, CRCRHAyisha Diop, MPH, Principal investigator, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805426
- Sponsor's protocol ID
- 3006
- Status last verified
- Feb 2018
- First submitted
- 9 Mar 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Diop A, Abbas D, Ngoc NTN, Martin R, Razafi A, Tuyet HTD, Winikoff B. A double-blind, randomized controlled trial to explore oral tranexamic acid as adjunct for the treatment for postpartum hemorrhage. Reprod Health. 2020 Mar 6;17(1):34. doi: 10.1186/s12978-020-0887-2.
PubMed 32143721
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized Controlled Trial to Assess the Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage
- ClinicalTrials.gov ID
- NCT02805426
- Acronym / sponsor ID
- 3006
- Conditions
- Postpartum Hemorrhage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Center for Research and Consultancy in Reproductive Health
- Study start
- Oct 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 20 Jun 2016 (estimated)
- 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.
This study is a randomized, double-blind, placebo controlled trial that will enroll 250 women (125 per study arm).
The objective of the study is to determine the efficacy and tolerability of oral tranexamic acid when used as an adjunct to misoprostol for treatment of postpartum hemorrhage (PPH). Women will be diagnosed with postpartum hemorrhage if blood loss reaches 700ml in the calibrated receptacle. If diagnosed with postpartum hemorrhage , the woman will be randomized to receive either tranexamic acid or placebo, both in tablet form. All participants will receive 800 mcg sublingual misoprostol (4 tablets 200mcg each).
The investigators hypothesize that tranexamic acid (in tablet form) as an adjunct to misoprostol will be more effective than misoprostol alone in stopping postpartum bleeding without recourse to further treatment in significantly more women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic Acid, Drug: Misoprostol1950 mg oral tranexamic acid + 800 mcg sublingual misoprostol |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Misoprostoloral placebo + 800 mcg sublingual misoprostol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women who delivery vaginally
- Women who experience PPH defined as blood loss ≥700ml
- Women capable of giving consent
Key exclusion criteria (3 listed)
- Clear contraindication for tranexamic acid such as known allergy or thromboembolic event during pregnancy
- Women delivering via cesarean section
- Provider feels that the woman, at presentation for delivery, is not in a position to give appropriate informed 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 |
|---|---|---|
| Tranexamic Acid | Drug | Tranexamic acid |
| Placebo | Drug | Placebo |
| Misoprostol | Drug | Placebo, Tranexamic acid |
Primary outcome
Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm
Time frame: 20 minutes after initial study treatment
10 secondary outcomes
Rate of severe PPH
Time frame: 2 hours after delivery
Mean/median blood loss
Time frame: at two hours after treatment
Proportion of women with controlled bleeding
Time frame: At various time intervals after study treatment (20, 40, 60, 120 mins)
Use of uterotonic agents after initial treatment
Time frame: 2 hours after delivery
Proportion of women who received a serious interventions
Time frame: 2 hours after delivery
Proportion of women who received additional drugs
Time frame: 2 hours after delivery
Proportion of women who receive additional intervention
Time frame: 2 hours after delivery
Adverse events
Time frame: 48 hours after delivery
Proportion of women who experience side effects
Time frame: 2 hours after delivery
Proportion of women who find the treatment tolerable
Time frame: 48 hours after 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 19 Feb 2018.
- Derived from this study: PubMed 32143721Diop A, Abbas D, Ngoc NTN, Martin R, Razafi A, Tuyet HTD, Winikoff B. A double-blind, randomized controlled trial to explore oral tranexamic acid as adjunct for the treatment for postpartum hemorrhage. Reprod Health. 2020 Mar 6;17(1):34. doi: 10.1186/s12978-020-0887-2.
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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.
Beverly Winikoff, MD, MPH principal investigator
Gynuity Health Projects
Jill Durocher principal investigator
Gynuity Health Projects
Dina Abbas, MPH principal investigator
Gynuity Health Projects
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid and Misoprostol in people with Postpartum Hemorrhage, run by Gynuity Health Projects at 4 sites in 2 countries.
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 3 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Senegal, Vietnam. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of women with bleeding controlled with the study regimens alone, without recourse to further treatment in each study arm (time frame: 20 minutes after initial study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805426, which also lists 1 linked publication.
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 19 Feb 2018.