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
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.
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 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
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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 .
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 .
operation time
recording total time of the surgery
Time frame: intraoperative
repair time
recording length of defect repair from placental separation until uterine wall closure
Time frame: intraoperative
Estimated blood loss
recording amount of blood loss
Time frame: intraoperative
packed red blood cells transfusion
recording amount of red blood cell transfused
Time frame: intraoperative until 24 hours after surgery
fresh frozen plasma (FFP) transfusion
recording amount of FFP transfusion
Time frame: intraoperative until 24 hours postoperative
Number of Participants who had Bladder injuries
Number of Participants who had Bladder injuries
Time frame: intraoperative until 2 weeks post operative
Number of Participants who had ureteral injuries
Number of Participants who had ureteral injuries
Time frame: intraoperative until 2 weeks post operative
Number of Participants who had bowel injury
Number of Participants who had bowel injury
Time frame: intraoperative until 2 weeks post operative
surgical site infection
record the presence of wound infection
Time frame: 24 hours until 1 month after surgery
urine output
recording amount of urine output
Time frame: intraoperative
internal iliac artery ligation
recording if the internal iliac artery ligated whether it was unilateral or bilateral
Time frame: intraoperative
pre-operative hemoglobin
recording amount of hemoglobin
Time frame: preoperative
post-operative hemoglobin
recording amount of hemoglobin
Time frame: postoperative within 6 hours from surgery
hospital stay
recording duration of hospital stay after surgery
Time frame: postoperative until 10 days after surgery
ICU admission
recording the number of patients admitted to the ICU
Time frame: immediate postoperative until 5 days after surgery
HDU high dependency unit admission
recording the number of patients admitted to high dependency unit
Time frame: postoperative until 10 days after surgery
surgical diagnosis
strategy to preserving the uterus when managing placenta accreta versus hysterectomy
Time frame: intraoperative
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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.
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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