Placenta AccretaNCT04193618
Conservative Surgery for Abnormally Invasive Placenta: A New Technique
A study testing Conservative surgery for placenta accretta in people with Placenta Accreta, run by Cairo University at 1 site in Egypt.
Trial summary
Placental borders and mapping by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively . bladder peritoneal dissection till the level of internal Os Uterus is incised away from the placenta *Baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Conservative surgery for placenta accretta
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 6 Mar 2021
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Placenta accreta spectrum, with partial or total invasion With area of invasion more than 7 cm in diameter
- patient's informed consent about the future risks of conservative management
- pregnancy > 20 weeks
Who cannot join
- * deeply pelvic placenta accreta spectrum cases with cervical invasion , by transvaginal ultrasound cervical length less than 21 mm
- cases with total invasion in which the area of invasion is more than 20 min diameter
- patient refusing conservative management and opting for hysterectomy
- medical comorbidities making massive hemorrhage more likely such as coagulopathies
- patient is in active antepartum hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Placental borders and mapping by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively .
bladder peritoneal dissection till the level of internal Os Uterus is incised away from the placenta
Read more
*Baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied rapidly control uterine incision site bleeding .
Twenty units of diluted oxytocin and 100 to 200 cc, 37°C of heated saline were infused from here, and then the cord was clamped .
Then we proceed to systemically devascularize the uterus with the placenta in site
- internal iliac artery distal ligation:
- broad ligament and ureteric dissection:
- uterine vessels :
- posterior uterine wall compression suture :
- The utero-ovarian anastomosis branches are spared to keep blood flowing to the uterus.
- if the bladder was not fully dissected from the anterior uterine wall , now we complete the dissection,
- anterior uterine wall compression suture :
- now , we excise the invaded , irreparable anterior wall segment, with the
- then separation of the placenta manually
- if there's still mild bleeding from the uterine placental bed another full myometrial thickness anterior or posterior uterine wall transverse sutures are applied below or above the placental bed site to control bleeding until it's deemed acceptable
- in cases with separate fundal anterior incision, the high incision is repaired in layers first to give more time to compress and monitor the lower segment
- refashioning of the Lower segment , repair transversely is usually done,
Read the detailed description
Placental borders and mapping were detected carefully by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively ..
According to the mapping, in a subset of patients we entered the abdomen by transverse suprapubic incision; in another subset we entered the abdomen by infraumbilical midline incision which was extended to a supra umbilical one in cases with anterior placentae with high upper margin .
Followed by bladder peritoneal dissection till either the level of internal Os is reached or a level with extensive adherence and/ or invasion.
Uterus is incised away from the placenta, according to the plan we described by placental mapping.
Type of uterine incisions is determined after placental mapping. Placental borders have been identified, and incisions were made far away from placenta. J-shaped, vertical and upper transverse incisions were used .
In cases of high anterior wall placentae a fundal anterior incision is made separate from the placental invaded uterine segment that will be excised later and both incisions will be repaired separately ..
- Baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied rapidly control uterine incision site bleeding .
Twenty units of diluted oxytocin and 100 to 200 cc, 37°C of heated saline were infused from here, and then the cord was clamped .
Then we proceed to systemically devascularize the uterus with the placenta in site
- internal iliac artery distal ligation: posterior pelvic peritoneum is incised and bilateral internal iliac arteries are ligated distally just before the offset of the uterine artery, to avoid collateral re-feeding of the internal iliac artery in case of proximal ligation
- broad ligament and ureteric dissection: the base of each broad ligament , both its leaflets and contents are dissected upwards , towards the utero-ovarian vessels away from the uterine lower segment , both ureters are dissected until each ureteric tunnel is identified , emptying the base of the broad ligament bilaterally helps apply temporary manual circumferencial pressure on cervix in cases of failed conservation and excess bleeding ,
- uterine vessels : simple or figure of 8 sutures are applied to each uterine artery and vein on each side incorporating 1 cm wide of the lateral part of the lower segment , this is done just below the placenta or 1 cm above the ureteric tunnel in cases of deep placental invasion .
In cases with extensive broad ligament invasion another high uterine vessels ligation is done to reduce bleeding from the spared utero-ovarian collaterals
- posterior uterine wall compression suture : transverse mattress suture is applied at the level of the lower most bulge of the placenta, as low as the levels of the ureteric tunnels
- The utero-ovarian anastomosis branches are spared to keep blood flowing to the uterus.
- if the bladder was not fully dissected from the anterior uterine wall , now we complete the dissection, noticing the bleeding is less in amount compared to cases we undertake bladder full dissection first before devascularization
- anterior uterine wall compression suture : A transverse mattress suture is placed below the placental bulge , incorporating most of the anterior uterine wall tissues , 1 cm medial to each uterine vessel ligatures , at a corresponding level to the posterior uterine compression suture, while avoiding incorporating the posterior uterine wall to avoid closing the cervical canal
- now , we excise the invaded , irreparable anterior wall segment, with the First inch of the incision we notice the uterine incision bleeding , in case the bleeding is low flow \& brown in colour in case of proper devascularization, if the bleeding is high flow bright red we revise our ligatures then continue the excision
- then separation of the placenta manually
- if there's still mild bleeding from the uterine placental bed another full myometrial thickness anterior or posterior uterine wall transverse sutures are applied below or above the placental bed site to control bleeding until it's deemed acceptable
- in cases with separate fundal anterior incision, the high incision is repaired in layers first to give more time to compress and monitor the lower segment
- refashioning of the Lower segment , repair transversely is usually done, in cases with a wide placental invasion disc excision of a diameter 15-20 cm, if the defect is long we close the incision longitudinally, while maintaining the cervical canal patent at all times
- we observe for vaginal bleeding for 20 - 30 minutes intraoperatively before abdominal wall closure
- closure over 2 wide bore drains
- we continue administration of oxytocin postoperatively
- we continue monitoring for vaginal bleeding for the next 24 hours
- Conditions
- Placenta Accreta
- Being tested
- Conservative surgery for placenta accretta
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative surgery for placenta accrettaProcedure or surgery
Uterine devasculrization and transverse compressing sutures before placental delivery
| Study group | Role | What they receive |
|---|---|---|
| Conservative surgery for placenta accretta | Experimental | Not described Receives: Procedure: Conservative surgery for placenta accretta |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
Blood loss = estimated blood volume (EBV) x preoperative hematocrit - postoperative hematocrit/preoperative hematocrit another method by weighing the towels and dressings before and after the procedure and adding the volume of fluid inside the suction apparatus
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Jan 2020
- Primary completion11 Dec 2020
- Study completion6 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placenta AccretaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M Maged, MD, Cairo University
- Investigators
- Ahmed maged, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193618
- Sponsor's protocol ID
- 173
- Status last verified
- Aug 2021
- First submitted
- 8 Dec 2019
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Surgery for Abnormally Invasive Placenta: A New Technique
- ClinicalTrials.gov ID
- NCT04193618
- Acronym / sponsor ID
- 173
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 6 Mar 2021 (actual)
- First posted
- 10 Dec 2019 (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.
Placental borders and mapping by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively .
bladder peritoneal dissection till the level of internal Os Uterus is incised away from the placenta
*Baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied rapidly control uterine incision site bleeding .
Twenty units of diluted oxytocin and 100 to 200 cc, 37°C of heated saline were infused from here, and then the cord was clamped .
Then we proceed to systemically devascularize the uterus with the placenta in site
- internal iliac artery distal ligation:
- broad ligament and ureteric dissection:
- uterine vessels :
- posterior uterine wall compression suture :
- The utero-ovarian anastomosis branches are spared to keep blood flowing to the uterus.
- if the bladder was not fully dissected from the anterior uterine wall , now we complete the dissection,
- anterior uterine wall compression suture :
- now , we excise the invaded , irreparable anterior wall segment, with the
- then separation of the placenta manually
- if there's still mild bleeding from the uterine placental bed another full myometrial thickness anterior or posterior uterine wall transverse sutures are applied below or above the placental bed site to control bleeding until it's deemed acceptable
- in cases with separate fundal anterior incision, the high incision is repaired in layers first to give more time to compress and monitor the lower segment
- refashioning of the Lower segment , repair transversely is usually done,
Detailed description
Placental borders and mapping were detected carefully by ultrasonography and Doppler ultrasonography (placental mapping) preop. And verified intraoperatively ..
According to the mapping, in a subset of patients we entered the abdomen by transverse suprapubic incision; in another subset we entered the abdomen by infraumbilical midline incision which was extended to a supra umbilical one in cases with anterior placentae with high upper margin .
Followed by bladder peritoneal dissection till either the level of internal Os is reached or a level with extensive adherence and/ or invasion.
Uterus is incised away from the placenta, according to the plan we described by placental mapping.
Type of uterine incisions is determined after placental mapping. Placental borders have been identified, and incisions were made far away from placenta. J-shaped, vertical and upper transverse incisions were used .
In cases of high anterior wall placentae a fundal anterior incision is made separate from the placental invaded uterine segment that will be excised later and both incisions will be repaired separately ..
- Baby was delivered , the uterus is exteriorised and 4-5 towel clips are applied rapidly control uterine incision site bleeding .
Twenty units of diluted oxytocin and 100 to 200 cc, 37°C of heated saline were infused from here, and then the cord was clamped .
Then we proceed to systemically devascularize the uterus with the placenta in site
- internal iliac artery distal ligation: posterior pelvic peritoneum is incised and bilateral internal iliac arteries are ligated distally just before the offset of the uterine artery, to avoid collateral re-feeding of the internal iliac artery in case of proximal ligation
- broad ligament and ureteric dissection: the base of each broad ligament , both its leaflets and contents are dissected upwards , towards the utero-ovarian vessels away from the uterine lower segment , both ureters are dissected until each ureteric tunnel is identified , emptying the base of the broad ligament bilaterally helps apply temporary manual circumferencial pressure on cervix in cases of failed conservation and excess bleeding ,
- uterine vessels : simple or figure of 8 sutures are applied to each uterine artery and vein on each side incorporating 1 cm wide of the lateral part of the lower segment , this is done just below the placenta or 1 cm above the ureteric tunnel in cases of deep placental invasion .
In cases with extensive broad ligament invasion another high uterine vessels ligation is done to reduce bleeding from the spared utero-ovarian collaterals
- posterior uterine wall compression suture : transverse mattress suture is applied at the level of the lower most bulge of the placenta, as low as the levels of the ureteric tunnels
- The utero-ovarian anastomosis branches are spared to keep blood flowing to the uterus.
- if the bladder was not fully dissected from the anterior uterine wall , now we complete the dissection, noticing the bleeding is less in amount compared to cases we undertake bladder full dissection first before devascularization
- anterior uterine wall compression suture : A transverse mattress suture is placed below the placental bulge , incorporating most of the anterior uterine wall tissues , 1 cm medial to each uterine vessel ligatures , at a corresponding level to the posterior uterine compression suture, while avoiding incorporating the posterior uterine wall to avoid closing the cervical canal
- now , we excise the invaded , irreparable anterior wall segment, with the First inch of the incision we notice the uterine incision bleeding , in case the bleeding is low flow \& brown in colour in case of proper devascularization, if the bleeding is high flow bright red we revise our ligatures then continue the excision
- then separation of the placenta manually
- if there's still mild bleeding from the uterine placental bed another full myometrial thickness anterior or posterior uterine wall transverse sutures are applied below or above the placental bed site to control bleeding until it's deemed acceptable
- in cases with separate fundal anterior incision, the high incision is repaired in layers first to give more time to compress and monitor the lower segment
- refashioning of the Lower segment , repair transversely is usually done, in cases with a wide placental invasion disc excision of a diameter 15-20 cm, if the defect is long we close the incision longitudinally, while maintaining the cervical canal patent at all times
- we observe for vaginal bleeding for 20 - 30 minutes intraoperatively before abdominal wall closure
- closure over 2 wide bore drains
- we continue administration of oxytocin postoperatively
- we continue monitoring for vaginal bleeding for the next 24 hours
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Conservative surgery for placenta accretta | Experimental | Procedure: Conservative surgery for placenta accretta |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Placenta accreta spectrum, with partial or total invasion With area of invasion more than 7 cm in diameter
Key exclusion criteria (5 listed)
- * deeply pelvic placenta accreta spectrum cases with cervical invasion , by transvaginal ultrasound cervical length less than 21 mm
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 |
|---|---|---|
| Conservative surgery for placenta accrettaUterine devasculrization and transverse compressing sutures before placental delivery | Procedure or surgery | Conservative surgery for placenta accretta |
Primary outcome
intraoperative blood loss
Time frame: during the operation
Blood loss = estimated blood volume (EBV) x preoperative hematocrit - postoperative hematocrit/preoperative hematocrit another method by weighing the towels and dressings before and after the procedure and adding the volume of fluid inside the suction apparatus
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 31 Aug 2021.
- 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.
Ahmed maged principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative surgery for placenta accretta in people with Placenta Accreta, run by Cairo University 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 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: finished, as of the sponsor's last update on 31 Aug 2021. 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?
intraoperative blood loss (time frame: during the operation). 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 31 Aug 2021.