Placenta AccretaNCT04593303
Internal Iliac Artery Ligation During Management of Placenta Accreta Spectrum
A study testing Internal iliac artery ligation with cervicoisthmic compression suture and Cervicoisthmic compression suture without Internal iliac artery ligation in people with Placenta Accreta, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
Vessels ligation have been used as a part of conservative management in treatment of placenta accrete spectrum to decrease blood loss as uterine artery ligation and internal iliac artery ligation. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Internal iliac artery ligation with cervicoisthmic compression suture and Cervicoisthmic compression suture without Internal iliac artery ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 1 Jan 2022
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 16Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validity of Internal Iliac Artery Ligation With Cervico Isthmic Compression Suture During Conservative Management of Placenta Accreta Spectrum
Vessels ligation have been used as a part of conservative management in treatment of placenta accrete spectrum to decrease blood loss as uterine artery ligation and internal iliac artery ligation. Surgical ligation of the anterior divisions of the internal iliac artery is practiced by many tertiary care centers during management of women with PAS disorders. However there is no recommendation toward the routine use of internal iliac artery ligation before bladder dissection during conservative management of (placenta accrete spectrum). The retroperitoneal space will be dissected and bifurcation of common iliac vessels will be identified, After identifying the ureter, the internal iliac artery will be dissected on both sides away from surrounding tissues and from adjacent iliac vein. The anterior branch of each internal iliac artery will be then prophylactically ligated using suture ligation approximately 2-3 cm distal to common iliac artery bifurcation in order to avoid ligation of the posterior division. Principal investigators will conduct a study to evaluate the efficacy of internal iliac artery ligation before bladder dissection during conservative management using cervico isthmic compression suture in cases of Placenta accrete spectrum.
Read the 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
- Conditions
- Placenta Accreta
- Being tested
- Internal iliac artery ligation with cervicoisthmic compression suture, Cervicoisthmic compression suture without Internal iliac artery ligation
- Keywords
- placenta accrete spectrum
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal iliac artery ligation with cervicoisthmic compression sutureProcedure or surgery
Retroperitoneal approach will be performed to ligate both internal iliac arteries before bladder dissection followed by cervicoisthmic compression suture application at placental bed
Cervicoisthmic compression suture without Internal iliac artery ligationProcedure or surgery
Bladder dissection followed by cervicoisthmic compression suture application at placental bed without Internal iliac artery ligation
| Study group | Role | What they receive |
|---|---|---|
| Internal iliac artery group | Active comparator | 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. . Receives: Procedure: Internal iliac artery ligation with cervicoisthmic compression suture |
| No internal iliac artery group | Other | Bladder dissection then bilateral uterine artery ligation then cervico isthmic suture without internal iliac artery ligation Receives: Procedure: Cervicoisthmic compression suture without Internal iliac artery ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of blood loss
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.
Measured: During surgery from the start of uterine incision till closure of abdominal wall
Secondary outcomes (1)
Complication rates,
the incidence of anesthetic, urologic injury, vascular injury, need of hysterectomy and intensive care unit admission.
Measured: from the induction of anesthesia till 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Sep 2020
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Taman, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593303
- Sponsor's protocol ID
- MS.20.09.1255
- Status last verified
- Apr 2022
- First submitted
- 12 Oct 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27527121Hecht 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.
PubMed 32415266Jauniaux 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.
PubMed 31173360
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of Internal Iliac Artery Ligation With Cervico Isthmic Compression Suture During Conservative Management of Placenta Accreta Spectrum
- ClinicalTrials.gov ID
- NCT04593303
- Acronym / sponsor ID
- MS.20.09.1255
- Conditions
- Placenta Accreta
- Keywords
- placenta accrete spectrum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 19 Oct 2020 (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.
Vessels ligation have been used as a part of conservative management in treatment of placenta accrete spectrum to decrease blood loss as uterine artery ligation and internal iliac artery ligation. Surgical ligation of the anterior divisions of the internal iliac artery is practiced by many tertiary care centers during management of women with PAS disorders. However there is no recommendation toward the routine use of internal iliac artery ligation before bladder dissection during conservative management of (placenta accrete spectrum). The retroperitoneal space will be dissected and bifurcation of common iliac vessels will be identified, After identifying the ureter, the internal iliac artery will be dissected on both sides away from surrounding tissues and from adjacent iliac vein. The anterior branch of each internal iliac artery will be then prophylactically ligated using suture ligation approximately 2-3 cm distal to common iliac artery bifurcation in order to avoid ligation of the posterior division. Principal investigators will conduct a study to evaluate the efficacy of internal iliac artery ligation before bladder dissection during conservative management using cervico isthmic compression suture in cases of Placenta accrete spectrum.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Internal iliac artery group | Active comparator | Procedure: Internal iliac artery ligation with cervicoisthmic compression sutureBilateral 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. . |
| No internal iliac artery group | Other | Procedure: Cervicoisthmic compression suture without Internal iliac artery ligationBladder dissection then bilateral uterine artery ligation then cervico isthmic suture without internal iliac artery ligation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
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 |
|---|---|---|
| Internal iliac artery ligation with cervicoisthmic compression sutureRetroperitoneal approach will be performed to ligate both internal iliac arteries before bladder dissection followed by cervicoisthmic compression suture application at placental bed | Procedure or surgery | Internal iliac artery group |
| Cervicoisthmic compression suture without Internal iliac artery ligationBladder dissection followed by cervicoisthmic compression suture application at placental bed without Internal iliac artery ligation | Procedure or surgery | No internal iliac artery group |
Primary outcome
Estimation of blood loss
Time frame: During surgery from the start of uterine incision till closure of abdominal wall
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.
1 secondary outcome
Complication rates,
Time frame: from the induction of anesthesia till 24 hours after the end of surgery
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 6 Apr 2022.
- Background: PubMed 27527121Sawada 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.
- Background: PubMed 32415266Hecht 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.
- Background: PubMed 31173360Jauniaux 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.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal iliac artery ligation with cervicoisthmic compression suture and Cervicoisthmic compression suture without Internal iliac artery ligation in people with Placenta Accreta, run by Mansoura University Hospital at 1 site in Egypt.
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 16 inclusion and 9 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Estimation of blood loss (time frame: During surgery from the start of uterine incision till closure of abdominal wall). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04593303, which also lists 3 linked publications.
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 6 Apr 2022.