Placenta AccretaNCT03707132
Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta
An observational study of Placenta Accreta and Post Partum Hemorrhage, run by University Tunis El Manar.
Trial summary
Monocentric prospective observational study comparing the use of tourniquet in low uterus segement versus standard procedure in hysterectomy owing to placenta accreta Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Accreta, Post Partum Hemorrhage, Blood Loss Massive
- What is being tested?
- Tourniquet: Folley catheter in the low segment of the uterus
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2014to 30 Sep 2017
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All parturients with suspected placenta accreta either on MRI if the C section is scheduled or on Ultrasound if an emmergent delivery is set
Who may be able to join
- . All patients undergoing scheduled or emergency cesarean section for placenta accreta
Who cannot join
- No signs of accretetization upon artificial delivery
About this study
Official title: Tourniquet on the Low Segment of the Uterus Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta: Old But Gold
Monocentric prospective observational study comparing the use of tourniquet in low uterus segement versus standard procedure in hysterectomy owing to placenta accreta
Read the detailed description
It is a monocentric prospective observational case-control study in the Department "C" of Gynecology and Obstetrics in the Maternity and Neonatology Center of Tunis during three years from October 2014 to September 2017.
All parturient were informed about the possibility of performing a hysterectomy if accretization was clinically confirmed preoperatively. After obtaining written formal consent. all patients who underwent scheduled or emergency cesarean section for placenta accreta were included. Either it was highly suspected or confirmed by obstetrical imaging. MRI was always performed in cases of scheduled cesarean delivery. However, in cases of delayed transfer or if parturient was already in labor, only ultrasonography was done and considered as sufficient. Delivery was usually scheduled at 36 weeks of gestation.
Patients were allocated into two group: Group TG in which a tourniquet was systematically applied on the lower segment of the uterus during emergent hysterectomy, control group CG when the emergent caesarian hysterectomy was performed without a tourniquet. Allocation depended on the technique and the decision of the surgeon in charge.
After appropriate conditioning and monitoring, the cesarean section was performed under general anesthesia. The laparotomy was performed through a mid-line incision from the umbilicus to the pubic symphysis. Hysterotomy was made far from the placental insertion which was previously located by ultrasonography. The accretization was clinically checked immediately after delivery but no attempt was made to manually remove the placenta. The umbilical cord was ligated to its insertion and the uterus was quickly sutured with the placenta kept in place. Careful detachment of the bladder-uterus peritoneum was then carried out in order to lower the bladder and reduce the risk of bladder wounds. Tourniquet application procedure is described as following
- Suturing hysterotomy with placenta kept in place.
- After a cautious dissection a Folley catheter is placed in the lower segment of the uterus as tourniquet.
- complete hysterectomy
- Conditions
- Placenta Accreta, Post Partum Hemorrhage, Blood Loss Massive
- Being tested
- Tourniquet: Folley catheter in the low segment of the uterus
- Keywords
- Tourniquet, low uterus segment, placenta accreta, hysterectomy, massive blood loss management
- Medical subject headings
- Placenta Accreta, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tourniquet: Folley catheter in the low segment of the uterusProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet Group | 'Tourniquet: Folley catheter in the low segment of the uterus Receives: Procedure: Tourniquet: Folley catheter in the low segment of the uterus | |
| Control Group | Standard hysterectomy is performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss
Blood spoliation during procedure
Measured: peroperatively
Hemoglobin variation
the differnece between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure
Measured: First 24 hours
Transfusion requirements
Number of red blood cells units transfused
Measured: First 24 hours
procedure duration
Time needed to perform hysterectomy from incision to skin closure
Measured: peroperatively
Intensive care transfer rate
Intensive care transfer following hysterectomy for placenta accreta
Measured: first 24 hours
Secondary outcomes (4)
length of stay in ICU
duration of the stay in the ICU following hysterectomy for placenta accreta
Measured: time from surgery up to 30 days postoperative
clotting disorders
Assessed by the incidence of Intravascular disseminated coagulopathy
Measured: time from surgery up to 30 days postoperative
Bladder wound
Incidence of accidental bladder damage
Measured: time from surgery up to 30 days postoperative
Digestive wound
Incidence of accidental digestive lesion
Measured: time from surgery up to 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start1 Oct 2014
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ben marzouk Sofiene, University Tunis El Manar
- Investigators
- Hayen Maghrebi, Professor, Study chair, Tunis Maternity Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707132
- Sponsor's protocol ID
- Garrot-Accreta
- Status last verified
- Oct 2018
- First submitted
- 7 Oct 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- 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 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tourniquet on the Low Segment of the Uterus Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta: Old But Gold
- ClinicalTrials.gov ID
- NCT03707132
- Acronym / sponsor ID
- Garrot-Accreta
- Conditions
- Placenta Accreta, Post Partum Hemorrhage, Blood Loss Massive
- Keywords
- Tourniquet, low uterus segment, placenta accreta, hysterectomy, massive blood loss management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 16 Oct 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.
Monocentric prospective observational study comparing the use of tourniquet in low uterus segement versus standard procedure in hysterectomy owing to placenta accreta
Detailed description
It is a monocentric prospective observational case-control study in the Department "C" of Gynecology and Obstetrics in the Maternity and Neonatology Center of Tunis during three years from October 2014 to September 2017.
All parturient were informed about the possibility of performing a hysterectomy if accretization was clinically confirmed preoperatively. After obtaining written formal consent. all patients who underwent scheduled or emergency cesarean section for placenta accreta were included. Either it was highly suspected or confirmed by obstetrical imaging. MRI was always performed in cases of scheduled cesarean delivery. However, in cases of delayed transfer or if parturient was already in labor, only ultrasonography was done and considered as sufficient. Delivery was usually scheduled at 36 weeks of gestation.
Patients were allocated into two group: Group TG in which a tourniquet was systematically applied on the lower segment of the uterus during emergent hysterectomy, control group CG when the emergent caesarian hysterectomy was performed without a tourniquet. Allocation depended on the technique and the decision of the surgeon in charge.
After appropriate conditioning and monitoring, the cesarean section was performed under general anesthesia. The laparotomy was performed through a mid-line incision from the umbilicus to the pubic symphysis. Hysterotomy was made far from the placental insertion which was previously located by ultrasonography. The accretization was clinically checked immediately after delivery but no attempt was made to manually remove the placenta. The umbilical cord was ligated to its insertion and the uterus was quickly sutured with the placenta kept in place. Careful detachment of the bladder-uterus peritoneum was then carried out in order to lower the bladder and reduce the risk of bladder wounds. Tourniquet application procedure is described as following
- Suturing hysterotomy with placenta kept in place.
- After a cautious dissection a Folley catheter is placed in the lower segment of the uterus as tourniquet.
- complete hysterectomy
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourniquet Group | – | Procedure: Tourniquet: Folley catheter in the low segment of the uterus'Tourniquet: Folley catheter in the low segment of the uterus |
| Control Group | – | –Standard hysterectomy is performed |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All parturients with suspected placenta accreta either on MRI if the C section is scheduled or on Ultrasound if an emmergent delivery is set
Key inclusion criteria (1 listed)
- . All patients undergoing scheduled or emergency cesarean section for placenta accreta
Key exclusion criteria (1 listed)
- No signs of accretetization upon artificial delivery
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 |
|---|---|---|
| Tourniquet: Folley catheter in the low segment of the uterus | Procedure or surgery | Tourniquet Group |
Primary outcome
Estimated blood loss
Time frame: peroperatively
Blood spoliation during procedure
Hemoglobin variation
Time frame: First 24 hours
the differnece between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure
Transfusion requirements
Time frame: First 24 hours
Number of red blood cells units transfused
procedure duration
Time frame: peroperatively
Time needed to perform hysterectomy from incision to skin closure
Intensive care transfer rate
Time frame: first 24 hours
Intensive care transfer following hysterectomy for placenta accreta
4 secondary outcomes
length of stay in ICU
Time frame: time from surgery up to 30 days postoperative
clotting disorders
Time frame: time from surgery up to 30 days postoperative
Bladder wound
Time frame: time from surgery up to 30 days postoperative
Digestive wound
Time frame: time from surgery up to 30 days postoperative
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 16 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Hayen Maghrebi, Professor study chair
Tunis Maternity Center
Questions about this trial
What is this clinical trial studying?
An observational study of Placenta Accreta and Post Partum Hemorrhage, run by University Tunis El Manar.
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 1 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Estimated blood loss (time frame: peroperatively). The study lists 5 primary outcomes in all. 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 16 Oct 2018.