NCT04193618

Brief 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,

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2021

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

December 8, 2019

Last Update Submit

August 30, 2021

Conditions

Placenta Accreta

Outcome Measures

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

    during the operation

Study Arms (1)

Conservative surgery for placenta accretta

EXPERIMENTAL
Procedure: Conservative surgery for placenta accretta

Interventions

Conservative surgery for placenta accrettaPROCEDURE

Uterine devasculrization and transverse compressing sutures before placental delivery

Conservative surgery for placenta accretta

Eligibility Criteria

Age19 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \* 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • Ahmed maged

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 8, 2019

First Posted

December 10, 2019

Study Start

January 1, 2020

Primary Completion

December 11, 2020

Study Completion

March 6, 2021

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)