Placenta PreviaNCT03741114
Foley's Catheter Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa
A study testing Foley's Catheter and TA in people with Placenta Previa, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 150-250 live births. Insertion of intrauterine balloon tamponade has been suggested in the management of massive postpartum hemorrhage (PPH). 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?
- Foley's Catheter and TA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2018to 1 Feb 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
- all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa
Who cannot join
- Patients with a cardiac, hepatic, renal or thromboembolic disease
- patients with the high possibility of the morbid adherent placenta
- known coagulopathy or thromboembolic disease
- those presented with severe antepartum hemorrhage
- 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
Aswān, 81528
hany f sallam, md, 01092440504 ext. 002, nahla.elsayed@aswu.ed.eg
Nahla w Shady, m, 1019240504 ext. 002, nahla.elsayed@aswu.edu.eg
About this study
Official title: Intrauterine Inflated Foley's Catheter Balloon Plus Intravenous Tranexamic Acid During Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial
Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 150-250 live births. Insertion of intrauterine balloon tamponade has been suggested in the management of massive postpartum hemorrhage (PPH). The Bakri balloon has a sausage-like spindle shape and a drainage lumen and is made of silicon. It has been used in cases of uterine atony and placenta previa with a success rate of 90%. However, Bakri balloon is not available in all countries.
The aim of this study is to evaluate the efficacy of the use of intrauterine inflated Foley's catheter balloon with or without intravenous tranexamic acid to control PPH during cesarean delivery in cases of placenta previa.
Read the detailed description
Eligible participants were allocated to one of two groups. Group (I): patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus. Group (II): patients received 1 gm tranexamic acid (TA), (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus Intrauterine Inflated Foley's Catheter Balloon. In group I, patients received a single injection of intravenous saline before skin incision prepared in a syringe and coded by a pharmacist in the pharmacy of the hospital. Neither the surgeon nor the anesthetist will know the nature of the IV administered drug before cesarean section.
- Conditions
- Placenta Previa
- Being tested
- Foley's Catheter, TA, Placebo
- Keywords
- placenta previa, tranexamic acid, cesarean section, Foley's Catheter 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.
Foley's CatheterProcedure or surgery
Also called Active Comparator
patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.
TADrug
Also called active comparator
patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline
PlaceboDrug
Also called Placebo to TA
patients received 100 ml saline just before skin incision
| Study group | Role | What they receive |
|---|---|---|
| Foley's Catheter plus TA | Active comparator | patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus 1 gm tranexamic acid in 100ml saline intravenous just before skin incision Receives: Procedure: Foley's Catheter; Drug: TA |
| Foley's Catheter plus placebo to TA | Active comparator | patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus single injection of 100 ml intravenous saline before skin incision Receives: Procedure: Foley's Catheter; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with postpartum hemorrhage
number of participant with blood loss > 1000ml
Measured: 24 hours post operative
Secondary outcomes (3)
intraoperative blood loss
amount of blood loss during cesarean section
Measured: during the operation
The number of participant needed for blood transfusion
Calculation of the number of participant needed for blood transfusion
Measured: 24 hours postoperative
number of participant need of extra surgical maneuvers
number of participant need of extra surgical maneuvers like internal iliac ligation or hysterectomy
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 posted14 Nov 2018
- Study start1 Dec 2018
- Primary completion30 Nov 2020 (estimated)
- Study completion1 Feb 2021 (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
- The study was a double-blind randomized controlled trial carried out in a tertiary University Hospital
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03741114
- Sponsor's protocol ID
- aswu/199/18
- Status last verified
- Jan 2019
- First submitted
- 12 Nov 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- 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 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Inflated Foley's Catheter Balloon Plus Intravenous Tranexamic Acid During Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03741114
- Acronym / sponsor ID
- aswu/199/18
- Conditions
- Placenta Previa
- Keywords
- placenta previa, tranexamic acid, cesarean section, Foley's Catheter Balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 14 Nov 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.
Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 150-250 live births. Insertion of intrauterine balloon tamponade has been suggested in the management of massive postpartum hemorrhage (PPH). The Bakri balloon has a sausage-like spindle shape and a drainage lumen and is made of silicon. It has been used in cases of uterine atony and placenta previa with a success rate of 90%. However, Bakri balloon is not available in all countries.
The aim of this study is to evaluate the efficacy of the use of intrauterine inflated Foley's catheter balloon with or without intravenous tranexamic acid to control PPH during cesarean delivery in cases of placenta previa.
Detailed description
Eligible participants were allocated to one of two groups. Group (I): patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus. Group (II): patients received 1 gm tranexamic acid (TA), (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus Intrauterine Inflated Foley's Catheter Balloon. In group I, patients received a single injection of intravenous saline before skin incision prepared in a syringe and coded by a pharmacist in the pharmacy of the hospital. Neither the surgeon nor the anesthetist will know the nature of the IV administered drug before 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
- 2
- Model description
- The study was a double-blind randomized controlled trial carried out in a tertiary University Hospital
| Arm | Type | Receives |
|---|---|---|
| Foley's Catheter plus TA | Active comparator | Procedure: Foley's Catheter, Drug: TApatients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus 1 gm tranexamic acid in 100ml saline intravenous just before skin incision |
| Foley's Catheter plus placebo to TA | Active comparator | Procedure: Foley's Catheter, Drug: Placebopatients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus plus single injection of 100 ml intravenous saline before skin incision |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa
Key exclusion criteria (6 listed)
- Patients with a cardiac, hepatic, renal or thromboembolic disease
- patients with the high possibility of the morbid adherent placenta
- known coagulopathy or thromboembolic disease
- those presented with severe antepartum hemorrhage
- hypersensitivity or contraindications of use of tranexamic acid
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 |
|---|---|---|
| Foley's CatheterAlso: Active Comparatorpatients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus. | Procedure or surgery | Foley's Catheter plus TA, Foley's Catheter plus placebo to TA |
| TAAlso: active comparatorpatients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline | Drug | Foley's Catheter plus TA |
| PlaceboAlso: Placebo to TApatients received 100 ml saline just before skin incision | Drug | Foley's Catheter plus placebo to TA |
Primary outcome
Number of Participants with postpartum hemorrhage
Time frame: 24 hours post operative
number of participant with blood loss > 1000ml
3 secondary outcomes
intraoperative blood loss
Time frame: during the operation
The number of participant needed for blood transfusion
Time frame: 24 hours postoperative
number of participant need of extra surgical maneuvers
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 9 Jan 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Placenta Previa
Not yet recruiting
ERAS Protocol for Cesarean Delivery in Women With Placenta Previa
Placenta Previa
Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
RecruitingObservational study
AI Blind-Sweep Ultrasound for Antenatal Screening by Non-Specialist Health Workers in Rural DR Congo
Antenatal Care, Maternal Health
Recruiting
Effect of a Cervical Pessary on the Rate of Bleeding in Placenta Praevia
Placenta Previa
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 Foley's Catheter and TA 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 6 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 9 Jan 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?
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?
Number of Participants with postpartum hemorrhage (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 9 Jan 2019.