- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04593303
Internal Iliac Artery Ligation During Management of Placenta Accreta Spectrum
Validity of Internal Iliac Artery Ligation With Cervico Isthmic Compression Suture During Conservative Management of Placenta Accreta Spectrum
Study Overview
Status
Conditions
Detailed Description
Surgical technique for all participants will be (Cervico isthmic compression suture)
Steps:
- Abdominal wall Incision will be done either in the midline or transverse suprapubic incision.
- Opening the abdominal wall in layers.
- Uterine incision will be done at the upper border of the placenta determined at laparotomy by naked eye.
- Delivery of the baby. Then the placenta will be left in place till doing devascularisation and bladder dissection
- Participants then will be, divided into two groups Participants in internal iliac group will undergo internal iliac artery ligation before bladder dissection Participants in no internal iliac artery group will undergo bladder dissection immediately without internal iliac artery ligation
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Dakahlia
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Mansoura, Dakahlia, Egypt, 050
- Faculty of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant female age between 18_35 years.
- History of ' 3 caesarean deliveries or less .
- Pregnant female diagnosed to have none complicated medical disorders e.g. Uncontrolled hypertension, Uncontrolled preeclampsia, Uncontrolled Diabetes mellitus .
If ≥2 of the following criteria present by trans abdominal ultrasound and color Doppler examination:
a-Loss of clear zone c-Placental lacunae. e-Placental bulge. g-Utero-vesical. hyper vascularity. i-Bridging vessels. b-Myometrial thinning. d-Bladder wall interruption. f-Focal exophytic mass. h-Subplacental.hyper vascularity. j-Lacunae feeder vessels.
- Placenta increta or percreta according to FIGO classification (2019)including:
1. Grade II(FIGO 2019 ) 8:Abnormally invasive placenta (Increta)
Clinical criteria):
At laparotomy Abnormal macroscopic findings over the placental bed: bluish/purple coloring, distension (placental "bulge").
Significant amounts of hyper vascularity (dense tangled bed of vessels or multiple vessels running parallel craniocaudally in the uterine serosa).
No placental tissue seen to be invading through the uterine serosa. Gentle cord traction results in the uterus being pulled inwards without separation of the placenta (so-called the dimple sign).
Histologic criteria:
Hysterectomy specimen or partial myometrial resection of the increta area shows placental villi within the muscular fibers and sometimes in the lumen of the deep uterine vasculature (radial or arcuate arteries),if failed conservative therapy.
2. Grade III(FIGO 2019)8: Abnormally invasive placenta (Percreta) Grade 3a: Limited to the uterine serosa Clinical criteria At laparotomy Abnormal macroscopic findings on uterine serosal surface (as above) and placental tissue seen to be invading through the surface of the uterus.
No invasion into any other organ, including the posterior wall of the bladder (a clear surgical plan can be identified between bladder and uterus).
Histologic criteria Hysterectomy specimen showing villous tissue within or breaching the uterine serosa.
Exclusion Criteria:
- Pregnant female age more than 35 Years.
- History of more than 3 caesarean deliveries.
- Patient refusing conservative management.
- Uncontrolled maternal diabetes, hypertension, Preeclampsia and Decompensated Rheumatic Heart Disease.
- Placenta accrete( FiGO 2019 ) 8classification Grade I:
Abnormally adherent placenta (placenta adherenta or accreta) Clinical criteria Macroscopically, the uterus shows no obvious distension over the placental bed (placental "bulge"), no placental tissue is seen invading through the surface of the uterus, and there is no or minimal neovascularity Histologic criteria Microscopic examination of the placental bed samples from hysterectomy specimen shows extended areas of absent decidua between villous tissue and myometrium with placental villi attached directly to the superficial myometrium The diagnosis cannot be made on just delivered placental tissue nor on random biopsies of the placental bed.
3. Grade III(FIGO 2019)8: Abnormally invasive placenta (Percreta) Grade 3b: With urinary bladder invasion Clinical criteria At laparotomy Placental villi are seen to be invading into the bladder but no other organs. Clear surgical plan cannot be identified between the bladder a uterus. Histologic criteria Hysterectomy specimen showing villous tissue breaching the uterine serosa and invading the bladder wall tissue or urothelium.
Grade 3c: With invasion of other pelvic tissue/organ Clinical criteria At laparotomy Placental villi are seen to be invading into the broad ligament, vaginal wall, pelvic sidewall or any other pelvic organ (with or without invasion of the bladder).
Histologic criteria Hysterectomy specimen showing villous tissue breaching the uterine serosa and invading pelvic tissues/organs (with or without invasion of the bladder) For the purposes of this classification, "uterus" includes the uterine body and uterine cervix.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Internal iliac artery group
Bilateral internal Iliac artery ligation will be done followed by urinary bladder dissection then bilateral uterine artery ligation then manual removal of the placenta then cervico isthmic compression suture.
(holding the upper border of the cervix by 4 Allis's forceps then suturing the cervix with the anterior uterine wall using continuous suture), Nelaton catheter18 gauge or Hegar's dilator will be inserted inside cervical canal during Cervico isthmic tamponed suture to ensure patency of cervical canal. .
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Retroperitoneal approach will be performed to ligate both internal iliac arteries before bladder dissection followed by cervicoisthmic compression suture application at placental bed
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Other: No internal iliac artery group
Bladder dissection then bilateral uterine artery ligation then cervico isthmic suture without internal iliac artery ligation
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Bladder dissection followed by cervicoisthmic compression suture application at placental bed without Internal iliac artery ligation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimation of blood loss
Time Frame: During surgery from the start of uterine incision till closure of abdominal wall
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The sum of a) Difference in Towels weighting dry & soaked .
b) Volume of blood in suction apparatus.
estimating the difference in Hemoglobin and Hematocrit before and after operation.
estimating the number of packed red blood cells units transfused.
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During surgery from the start of uterine incision till closure of abdominal wall
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complication rates,
Time Frame: from the induction of anesthesia till 24 hours after the end of surgery
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the incidence of anesthetic, urologic injury, vascular injury, need of hysterectomy and intensive care unit admission.
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from the induction of anesthesia till 24 hours after the end of surgery
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Jauniaux E, Ayres-de-Campos D, Langhoff-Roos J, Fox KA, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO classification for the clinical diagnosis of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2019 Jul;146(1):20-24. doi: 10.1002/ijgo.12761.
- Hecht JL, Baergen R, Ernst LM, Katzman PJ, Jacques SM, Jauniaux E, Khong TY, Metlay LA, Poder L, Qureshi F, Rabban JT 3rd, Roberts DJ, Shainker S, Heller DS. Classification and reporting guidelines for the pathology diagnosis of placenta accreta spectrum (PAS) disorders: recommendations from an expert panel. Mod Pathol. 2020 Dec;33(12):2382-2396. doi: 10.1038/s41379-020-0569-1. Epub 2020 May 15.
- Sawada M, Matsuzaki S, Mimura K, Kumasawa K, Endo M, Kimura T. Successful conservative management of placenta percreta: Investigation by serial magnetic resonance imaging of the clinical course and a literature review. J Obstet Gynaecol Res. 2016 Dec;42(12):1858-1863. doi: 10.1111/jog.13121. Epub 2016 Aug 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS.20.09.1255
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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