Placenta PreviaNCT04518163
Bakri Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa
A study testing Tranexamic Acid and Bakri Balloon in people with Placenta Previa, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Objective to investigate the effect of adjunctive intravenous tranexamic acid (TA) on blood loss during cesarean section (CS) in patients with placenta previa undergone Bakri balloon tamponade Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Placenta Previa
- What is being tested?
- Tranexamic Acid and Bakri Balloon
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 31 Jul 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 undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Who cannot join
- patients with the high possibility of morbid adherent placenta
- those presented with severe antepartum hemorrhage
- Patients with cardiac, hepatic, renal, or thromboembolic disease;
- hypersensitivity or contraindications of use of tranexamic acid
- patient refuses to consent
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān, 81528
Hany F Sallam, MD, 0122336052 ext. 002, hany.farouk@aswu.edu.eg
Nahla W Shady, MD, 01092440504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Bakri Balloon Tamponade Plus Intravenous Tranexamic Acid During Cesarean Delivery for Placenta Previa: a Randomized Double-blind Controlled Trial
Objective to investigate the effect of adjunctive intravenous tranexamic acid (TA) on blood loss during cesarean section (CS) in patients with placenta previa undergone Bakri balloon tamponade
Read the detailed description
Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate.
Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.
- Conditions
- Placenta Previa
- Being tested
- Tranexamic Acid, placebo to TA, Bakri Balloon
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TA
Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision
placebo to TADrug
Also called saline
Intravenous 110 ml saline by slow infusion before skin incision
Bakri BalloonDevice
Also called BBT
Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus 1gm tranexamic acid by intravenous infusion Receives: Drug: Tranexamic Acid; Device: Bakri Balloon |
| control group | Active comparator | Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus saline by intravenous infusion Receives: Drug: placebo to TA; Device: Bakri Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean Blood loss after placental separation
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
Measured: 30 minutes
Secondary outcomes (2)
Number of Participants with postpartum hemorrhage
number pf participants with blood loss > 1000ml
Measured: 12 hours
The number of participant needed of extra surgical maneuvers
Calculation of the number of participant needed of extra surgical maneuvers like internal iliac artery ligation
Measured: 30minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Sep 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta PreviaStudies 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 randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 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
- nahla w Shady, md, Study chair, Aswan universirty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518163
- Sponsor's protocol ID
- aswu/279/7/19
- Status last verified
- Sep 2020
- First submitted
- 15 Aug 2020
- Last updated
- 21 Sep 2020
- 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 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bakri Balloon Tamponade Plus Intravenous Tranexamic Acid During Cesarean Delivery for Placenta Previa: a Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT04518163
- Acronym / sponsor ID
- aswu/279/7/19
- Conditions
- Placenta Previa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 19 Aug 2020 (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.
Objective to investigate the effect of adjunctive intravenous tranexamic acid (TA) on blood loss during cesarean section (CS) in patients with placenta previa undergone Bakri balloon tamponade
Detailed description
Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate.
Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.
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 randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Drug: Tranexamic Acid, Device: Bakri BalloonBakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus 1gm tranexamic acid by intravenous infusion |
| control group | Active comparator | Drug: placebo to TA, Device: Bakri BalloonBakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally plus saline by intravenous infusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Key exclusion criteria (5 listed)
- patients with the high possibility of morbid adherent placenta
- those presented with severe antepartum hemorrhage
- Patients with cardiac, hepatic, renal, or thromboembolic disease;
- hypersensitivity or contraindications of use of tranexamic acid
- patient refuses 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 |
|---|---|---|
| Tranexamic AcidAlso: TAIntravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision | Drug | study group |
| placebo to TAAlso: salineIntravenous 110 ml saline by slow infusion before skin incision | Drug | control group |
| Bakri BalloonAlso: BBTBakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally | Device | control group, study group |
Primary outcome
mean Blood loss after placental separation
Time frame: 30 minutes
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
2 secondary outcomes
Number of Participants with postpartum hemorrhage
Time frame: 12 hours
The number of participant needed of extra surgical maneuvers
Time frame: 30minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No
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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.
nahla w Shady, md study chair
Aswan universirty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid and Bakri Balloon in people with Placenta Previa, 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: status not confirmed, as of the sponsor's last update on 21 Sep 2020. 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, md (+20102435461 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?
mean Blood loss after placental separation (time frame: 30 minutes). 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 21 Sep 2020.