CClinicalTrials.gg
CompletedNCT04193618Updated Aug 31, 2021

Conservative Surgery for Abnormally Invasive Placenta: A New Technique

An interventional study of Conservative surgery for placenta accretta in Placenta Accreta, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 19 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-08-31.

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

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
19 Years to 40 Years
Sex
Female
01

Study 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 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
02

Conditions studied

  • Placenta Accreta

Browse trials for

03

In context

Placenta Accreta

147 studies on the registry are indexed under Placenta Accreta; 39 are open to participants now.

This study's enrollment of 100 is above the median of 62 across 63 interventional studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
19 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • * 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Conservative surgery for placenta accretta

    Procedure: Conservative surgery for placenta accretta

Interventions

  • ProcedureConservative surgery for placenta accretta

    Uterine devasculrization and transverse compressing sutures before placental delivery

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: during the operation

07

Study locations

1 site
  • Kasr Alainy medical school
    Cairo, 12111, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04193618
Lead sponsor
Cairo University
Responsible party
Ahmed M Maged, MD (professor, Cairo University) — Principal investigator
First posted
Dec 10, 2019
Start date
Jan 1, 2020
Primary completion
Dec 11, 2020
Completion
Mar 6, 2021
Last update
Aug 31, 2021

Study contacts

Ahmed maged
principal investigator · Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion