Placenta Accreta SpectrumNCT06483724
Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to Segmental Resection Approach
A study testing cervical tourniquet and uterine artery ligation in people with Placenta Accreta Spectrum, run by Minia University.
Trial summary
The study will compare a modified surgical approach for preserving fertility and minimizing hemorrhage in morbidly adherent placenta during cesarean section with a cervical tourniquet against uterine artery ligation. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Placenta Accreta Spectrum
- What is being tested?
- cervical tourniquet and uterine artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 May 2025
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed sonographically to have placenta accreta spectrum .
- Pregnancy is singleton and fetus is alive.
- Elective caesarean section done from 36 gestational weeks
Who cannot join
- Patients requesting hysterectomy
- Coexisting uterine pathology such as fibroids or gynaecological malignancies
- Patients with bleeding diathesis.
- Morbid obesity of BMI >40.
- Patients having labour pains or vaginal bleeding before scheduled intervention
About this study
Official title: Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to the Segmental Resection Approach in Patients With Placenta Accreta Spectrum: A Prospective Interventional Study
The study will compare a modified surgical approach for preserving fertility and minimizing hemorrhage in morbidly adherent placenta during cesarean section with a cervical tourniquet against uterine artery ligation.
Read the detailed description
Study Design and Setting This was prospective interventional study that comprised the medical data of 82 pregnant women with placenta accreta who had caesarean section. . This study will be carried out In the Department of Obstetrics and Gynecology, Minia Maternity University Hospital (MMUH) .
after being approved by the local ethical Committee; If placenta accreta was clinically verified preoperatively, all parturients were informed of the option of a hysterectomy. After receiving written, formal consent . After receiving documented formal consent. The study included all patients who had a scheduled cesarean procedure for placenta accreta. Obstetrical imaging either verified or strongly suspected the diagnosis. During the prenatal period, a senior sonographer evaluated all patients using ultrasonography and color Doppler technology. An ultrasonographic assessment was done. Each patient was evaluated for retroplacental sonolucent zones, vascular lacunas, myometrial thinning, bladder line disruption, and exophytic masses . The Color Doppler scan evaluated placental lacunar flow, hypervascularity in the vesicouterine interface, and continuous retroplacental venous complex structures. A 3D Doppler scan was used to assess hypervascularity of the uterine serosa and bladder interphase, as well as uneven intraplacental vascularization
Assessment :
To assess the effectiveness of the proposed management strategy, participants were separated into two groups. In Group 1 (n = 41), a cervical tourniquet was used systematically. In Group 2 (n=41), uterine artery ligation was performed prior to segmental resection for uterine preservation surgery
Surgical scenarios :
Across both groups: Ultrasonographic data determine whether an abdominal incision should be performed with a Pfannensteil or a vertical midline incision from under the umbilicus to above the pubic symphysis.
- in group 1 After opening the abdominal wall, To reduce bleeding during PAS, make the uterine incision above the placenta's intrauterine borders. Before making the incision, an ultrasound check is recommended to find the uterine opening. Based on our assumptions, following the delivery of the fetus
- investigators was extract the uterus from the abdomen by gently grasp the fundus of the uterus and pull up and forward. Release uterine appendages on both sides by shifting the uterus to the right and left.
- An assistant slides a sterile Foley catheter (Ch 16/18 French) down to the lowest point and secures it "en bloc" around the cervix at the level of the uterosacral ligaments, approximately 3-4 cm below the incision. Then, tighten and fix it.
- The bladder peritoneum is isolated from the uterus through complex coagulation of perforating vascular systems . This step of surgery is crucial for the rest of the treatment. Due to the fragile and unpredictable nature of the vascular network, it is important to exercise caution. The bladder peritoneum is demarcated until the cervical internal ostium. To accomplish this procedure, an assistant places a finger on the anterior fornix of the vagina to create a reference point and assure full separation.
- To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors.
- The tourniquet approach achieves hemostasis, giving the operator time to assess the uterus's preservation potential.
- To assess active bleeding, the tourniquet can be removed.
- Suturing on the uterine pouches by suturing on the Uterine pouches is repaired by bringing the edges together with running sutures or using the internal os of the cervix as a natural tamponade helps produce hemostasis in the placental bed and adjacent areas.
- This approach provides time to prepare for a blood transfusion or seek assistance. The tourniquet approach can be utilized as both a primary therapy strategy for PAS and a follow-up after placental removal and bleeding.
In another group : the same steps in group 1 in steps 1, 2 and 3 4- The bladder peritoneum is isolated from the uterus 5 - The uterine vessels were ligated in continuity at the level of the utero-vesical fold on each side.
6- the same steps in group 1 in steps 5,6, 7and 8
- Conditions
- Placenta Accreta Spectrum
- Being tested
- cervical tourniquet, uterine artery ligation
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical tourniquetProcedure or surgery
After opening the abdominal wall, To reduce bleeding during PAS, make the uterine incision above the placenta's intrauterine borders .
2-investigators extract the uterus from the abdomen 3-An assistant slides a sterile Foley catheter (Ch 16/18 French) down to the lowest point and secures it "en bloc" around the cervix 4-The bladder peritoneum is isolated from the uterus 5-To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors .
uterine artery ligationProcedure or surgery
After opening the abdominal wall, To reduce bleeding during PAS, make the uterine incision above the placenta's intrauterine borders .
2-investigators extract the uterus from the abdomen 3-The bladder peritoneum is isolated from the uterus 4-The uterine vessels were ligated in continuity at the level of the utero-vesical fold on each side 5-To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors .
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (n = 41) cervical tourniquet | Experimental | in group 1 the investigators using a sterile Foley catheter (Ch 16/18 French) down to the lowest point and secures it "en bloc" around the cervix at the level of the uterosacral ligaments, approximately 3-4 cm below the incision. Then, tighten and fix . Receives: Procedure: cervical tourniquet |
| Group 2 (n=41) uterine artery ligation | Experimental | in group 2the investigators ligated the uterine vessels in a continuous manner at the level of the utero-vesical fold on each side. Receives: Procedure: uterine artery ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
recording total time of the surgery
Measured: intraoperative
repair time
recording length of defect repair from placental separation until uterine wall closure
Measured: intraoperative
Estimated blood loss
recording amount of blood loss
Measured: intraoperative
packed red blood cells transfusion
recording amount of red blood cell transfused
Measured: intraoperative until 24 hours after surgery
fresh frozen plasma (FFP) transfusion
recording amount of FFP transfusion
Measured: intraoperative until 24 hours postoperative
Number of Participants who had Bladder injuries
Number of Participants who had Bladder injuries
Measured: intraoperative until 2 weeks post operative
Number of Participants who had ureteral injuries
Number of Participants who had ureteral injuries
Measured: intraoperative until 2 weeks post operative
Number of Participants who had bowel injury
Number of Participants who had bowel injury
Measured: intraoperative until 2 weeks post operative
surgical site infection
record the presence of wound infection
Measured: 24 hours until 1 month after surgery
urine output
recording amount of urine output
Measured: intraoperative
internal iliac artery ligation
recording if the internal iliac artery ligated whether it was unilateral or bilateral
Measured: intraoperative
pre-operative hemoglobin
recording amount of hemoglobin
Measured: preoperative
post-operative hemoglobin
recording amount of hemoglobin
Measured: postoperative within 6 hours from surgery
hospital stay
recording duration of hospital stay after surgery
Measured: postoperative until 10 days after surgery
ICU admission
recording the number of patients admitted to the ICU
Measured: immediate postoperative until 5 days after surgery
HDU high dependency unit admission
recording the number of patients admitted to high dependency unit
Measured: postoperative until 10 days after surgery
surgical diagnosis
strategy to preserving the uterus when managing placenta accreta versus hysterectomy
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta Accreta SpectrumStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hassan Mohamed Abdel Ghfar, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483724
- Sponsor's protocol ID
- Placenta Accreta Spectrum
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- 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 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to the Segmental Resection Approach in Patients With Placenta Accreta Spectrum: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT06483724
- Acronym / sponsor ID
- Placenta Accreta Spectrum
- Conditions
- Placenta Accreta Spectrum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 3 Jul 2024 (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 study will compare a modified surgical approach for preserving fertility and minimizing hemorrhage in morbidly adherent placenta during cesarean section with a cervical tourniquet against uterine artery ligation.
Detailed description
Study Design and Setting This was prospective interventional study that comprised the medical data of 82 pregnant women with placenta accreta who had caesarean section. . This study will be carried out In the Department of Obstetrics and Gynecology, Minia Maternity University Hospital (MMUH) .
after being approved by the local ethical Committee; If placenta accreta was clinically verified preoperatively, all parturients were informed of the option of a hysterectomy. After receiving written, formal consent . After receiving documented formal consent. The study included all patients who had a scheduled cesarean procedure for placenta accreta. Obstetrical imaging either verified or strongly suspected the diagnosis. During the prenatal period, a senior sonographer evaluated all patients using ultrasonography and color Doppler technology. An ultrasonographic assessment was done. Each patient was evaluated for retroplacental sonolucent zones, vascular lacunas, myometrial thinning, bladder line disruption, and exophytic masses . The Color Doppler scan evaluated placental lacunar flow, hypervascularity in the vesicouterine interface, and continuous retroplacental venous complex structures. A 3D Doppler scan was used to assess hypervascularity of the uterine serosa and bladder interphase, as well as uneven intraplacental vascularization
Assessment :
To assess the effectiveness of the proposed management strategy, participants were separated into two groups. In Group 1 (n = 41), a cervical tourniquet was used systematically. In Group 2 (n=41), uterine artery ligation was performed prior to segmental resection for uterine preservation surgery
Surgical scenarios :
Across both groups: Ultrasonographic data determine whether an abdominal incision should be performed with a Pfannensteil or a vertical midline incision from under the umbilicus to above the pubic symphysis.
- in group 1 After opening the abdominal wall, To reduce bleeding during PAS, make the uterine incision above the placenta's intrauterine borders. Before making the incision, an ultrasound check is recommended to find the uterine opening. Based on our assumptions, following the delivery of the fetus
- investigators was extract the uterus from the abdomen by gently grasp the fundus of the uterus and pull up and forward. Release uterine appendages on both sides by shifting the uterus to the right and left.
- An assistant slides a sterile Foley catheter (Ch 16/18 French) down to the lowest point and secures it "en bloc" around the cervix at the level of the uterosacral ligaments, approximately 3-4 cm below the incision. Then, tighten and fix it.
- The bladder peritoneum is isolated from the uterus through complex coagulation of perforating vascular systems . This step of surgery is crucial for the rest of the treatment. Due to the fragile and unpredictable nature of the vascular network, it is important to exercise caution. The bladder peritoneum is demarcated until the cervical internal ostium. To accomplish this procedure, an assistant places a finger on the anterior fornix of the vagina to create a reference point and assure full separation.
- To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors.
- The tourniquet approach achieves hemostasis, giving the operator time to assess the uterus's preservation potential.
- To assess active bleeding, the tourniquet can be removed.
- Suturing on the uterine pouches by suturing on the Uterine pouches is repaired by bringing the edges together with running sutures or using the internal os of the cervix as a natural tamponade helps produce hemostasis in the placental bed and adjacent areas.
- This approach provides time to prepare for a blood transfusion or seek assistance. The tourniquet approach can be utilized as both a primary therapy strategy for PAS and a follow-up after placental removal and bleeding.
In another group : the same steps in group 1 in steps 1, 2 and 3 4- The bladder peritoneum is isolated from the uterus 5 - The uterine vessels were ligated in continuity at the level of the utero-vesical fold on each side.
6- the same steps in group 1 in steps 5,6, 7and 8
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (n = 41) cervical tourniquet | Experimental | Procedure: cervical tourniquetin group 1 the investigators using a sterile Foley catheter (Ch 16/18 French) down to the lowest point and secures it "en bloc" around the cervix at the level of the uterosacral ligaments, approximately 3-4 cm below the incision. Then, tighten and fix . |
| Group 2 (n=41) uterine artery ligation | Experimental | Procedure: uterine artery ligationin group 2the investigators ligated the uterine vessels in a continuous manner at the level of the utero-vesical fold on each side. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed sonographically to have placenta accreta spectrum .
- Pregnancy is singleton and fetus is alive.
- Elective caesarean section done from 36 gestational weeks
Key exclusion criteria (5 listed)
- Patients requesting hysterectomy
- Coexisting uterine pathology such as fibroids or gynaecological malignancies
- Patients with bleeding diathesis.
- Morbid obesity of BMI >40.
- Patients having labour pains or vaginal bleeding before scheduled intervention
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 |
|---|---|---|
| cervical tourniquetAfter opening the abdominal wall, To reduce bleeding during PAS, make the uterine incision above the placenta's intrauterine borders . 2-investigators extract the uterus from the abdomen 3-An assistant slides a sterile Foley catheter (Ch 16/18 French) down to the lowest point and secures it "en bloc" around the cervix 4-The bladder peritoneum is isolated from the uterus 5-To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors . | Procedure or surgery | Group 1 (n = 41) cervical tourniquet |
| uterine artery ligationAfter opening the abdominal wall, To reduce bleeding during PAS, make the uterine incision above the placenta's intrauterine borders . 2-investigators extract the uterus from the abdomen 3-The bladder peritoneum is isolated from the uterus 4-The uterine vessels were ligated in continuity at the level of the utero-vesical fold on each side 5-To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors . | Procedure or surgery | Group 2 (n=41) uterine artery ligation |
Primary outcome
operation time
Time frame: intraoperative
recording total time of the surgery
repair time
Time frame: intraoperative
recording length of defect repair from placental separation until uterine wall closure
Estimated blood loss
Time frame: intraoperative
recording amount of blood loss
packed red blood cells transfusion
Time frame: intraoperative until 24 hours after surgery
recording amount of red blood cell transfused
fresh frozen plasma (FFP) transfusion
Time frame: intraoperative until 24 hours postoperative
recording amount of FFP transfusion
Number of Participants who had Bladder injuries
Time frame: intraoperative until 2 weeks post operative
Number of Participants who had Bladder injuries
Number of Participants who had ureteral injuries
Time frame: intraoperative until 2 weeks post operative
Number of Participants who had ureteral injuries
Number of Participants who had bowel injury
Time frame: intraoperative until 2 weeks post operative
Number of Participants who had bowel injury
surgical site infection
Time frame: 24 hours until 1 month after surgery
record the presence of wound infection
urine output
Time frame: intraoperative
recording amount of urine output
internal iliac artery ligation
Time frame: intraoperative
recording if the internal iliac artery ligated whether it was unilateral or bilateral
pre-operative hemoglobin
Time frame: preoperative
recording amount of hemoglobin
post-operative hemoglobin
Time frame: postoperative within 6 hours from surgery
recording amount of hemoglobin
hospital stay
Time frame: postoperative until 10 days after surgery
recording duration of hospital stay after surgery
ICU admission
Time frame: immediate postoperative until 5 days after surgery
recording the number of patients admitted to the ICU
HDU high dependency unit admission
Time frame: postoperative until 10 days after surgery
recording the number of patients admitted to high dependency unit
surgical diagnosis
Time frame: intraoperative
strategy to preserving the uterus when managing placenta accreta versus hysterectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing cervical tourniquet and uterine artery ligation in people with Placenta Accreta Spectrum, run by Minia University.
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 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 5 Jul 2024. 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?
Results are not available in the source record.
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?
operation time (time frame: intraoperative). The study lists 17 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 5 Jul 2024.