ClinicalTrials.gg
Not yet recruitingNCT06483724Updated Jul 5, 2024

Comparison Between Cervical Tourniquet and Uterine Artery Ligation Prior to Segmental Resection Approach

An interventional study of cervical tourniquet and uterine artery ligation in Placenta Accreta Spectrum, sponsored by Minia University. Not yet recruiting. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Minia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Randomized
Ages
18 Years to 38 Years
Sex
Female
01

Study 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 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.

  1. 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
  2. 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.
  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 at the level of the uterosacral ligaments, approximately 3-4 cm below the incision. Then, tighten and fix it.
  4. 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.
  5. To remove myometrial tissue, leave a margin of at least 2 cm superior to the cervical internal ostium using electrocautery or scissors.
  6. The tourniquet approach achieves hemostasis, giving the operator time to assess the uterus's preservation potential.
  7. To assess active bleeding, the tourniquet can be removed.
  8. 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.
  9. 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

02

Conditions studied

  • Placenta Accreta Spectrum

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03

In context

Placenta Accreta

150 studies on the registry are indexed under Placenta Accreta; 40 are open to participants now.

This study's planned enrollment of 82 is above the median of 70 across 67 interventional studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed sonographically to have placenta accreta spectrum .
  • Pregnancy is singleton and fetus is alive.
  • Elective caesarean section done from 36 gestational weeks

Exclusion criteria

Exclusion Criteria:

  • Patients requesting hysterectomy
  • Coexisting uterine pathology such as fibroids or gynaecological
  • Patients with bleeding diathesis.
  • Morbid obesity of >40.
  • Patients having labour pains or vaginal bleeding before scheduled intervention
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (estimated)

Study arms

  • Experimental
    Group 1 (n = 41) cervical tourniquet

    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 .

    Procedure: cervical tourniquet

  • Experimental
    Group 2 (n=41) uterine artery ligation

    in group 2the investigators ligated the uterine vessels in a continuous manner at the level of the utero-vesical fold on each side.

    Procedure: uterine artery ligation

Interventions

  • Procedurecervical tourniquet

    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 .

  • Procedureuterine artery ligation

    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 .

06

What researchers measure

Primary outcomes

  1. operation time

    recording total time of the surgery

    Time frame: intraoperative

  2. repair time

    recording length of defect repair from placental separation until uterine wall closure

    Time frame: intraoperative

  3. Estimated blood loss

    recording amount of blood loss

    Time frame: intraoperative

  4. packed red blood cells transfusion

    recording amount of red blood cell transfused

    Time frame: intraoperative until 24 hours after surgery

  5. fresh frozen plasma (FFP) transfusion

    recording amount of FFP transfusion

    Time frame: intraoperative until 24 hours postoperative

  6. Number of Participants who had Bladder injuries

    Number of Participants who had Bladder injuries

    Time frame: intraoperative until 2 weeks post operative

  7. Number of Participants who had ureteral injuries

    Number of Participants who had ureteral injuries

    Time frame: intraoperative until 2 weeks post operative

  8. Number of Participants who had bowel injury

    Number of Participants who had bowel injury

    Time frame: intraoperative until 2 weeks post operative

  9. surgical site infection

    record the presence of wound infection

    Time frame: 24 hours until 1 month after surgery

  10. urine output

    recording amount of urine output

    Time frame: intraoperative

  11. internal iliac artery ligation

    recording if the internal iliac artery ligated whether it was unilateral or bilateral

    Time frame: intraoperative

  12. pre-operative hemoglobin

    recording amount of hemoglobin

    Time frame: preoperative

  13. post-operative hemoglobin

    recording amount of hemoglobin

    Time frame: postoperative within 6 hours from surgery

  14. hospital stay

    recording duration of hospital stay after surgery

    Time frame: postoperative until 10 days after surgery

  15. ICU admission

    recording the number of patients admitted to the ICU

    Time frame: immediate postoperative until 5 days after surgery

  16. HDU high dependency unit admission

    recording the number of patients admitted to high dependency unit

    Time frame: postoperative until 10 days after surgery

  17. surgical diagnosis

    strategy to preserving the uterus when managing placenta accreta versus hysterectomy

    Time frame: intraoperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jul 2024; primary completion for Apr 2025, 9 months later.

Of 45 non-industry interventional studies with no phase under Placenta Accreta, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's planned 9 months is below that.

Counting every sponsor, half of 45 studies reached it within 19 months; a quarter within 12 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2024
First posted
Jul 3, 2024
StartEst.
Jul 1, 2024
Primary completionEst.
Apr 1, 2025
CompletionEst.
May 1, 2025
Last update
Jul 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06483724
Lead sponsor
Minia University
Responsible party
Mohamed Hassan Mohamed Abdel Ghfar (lecturer, Minia University) — Principal investigator
First posted
Jul 3, 2024
Start date
Jul 1, 2024 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Jul 5, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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