CClinicalTrials.gg
Status unknownNCT03676855Updated Sep 19, 2018

Comparison Between Bladder Dissection Before and After Uterine Incision in Cesarean Section for Morbidly Adherent Placenta

An interventional study of bladder dissection in Morbidly Adherent Placenta, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-19.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2018, registered Aug 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
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Study summary

Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy

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Conditions studied

  • Morbidly Adherent Placenta

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03

In context

Placenta Accreta

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

This study's planned enrollment of 60 is close to the median of 62 across 63 interventional studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Women with BMI at or under 35 Kg/m2.
  2. Women having previous two cesarean section or more.
  3. Women with gestational age more than 32 weeks with viable fetus.
  4. Women with any degree of placenta previa .
  5. Patient with morbidly adherent placenta on cesarean scar only.

Exclusion criteria

Exclusion Criteria:

  1. Patient who are haemodynamically unstable before skin incision.
  2. Patient with clinically evident intraamniotic infection.
  3. Patient with previous history of bladder injury .
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    bladder dissection before uterine incision

    Procedure: bladder dissection

  • Experimental
    bladder dissection after uterine incision

    Procedure: bladder dissection

Interventions

  • Procedurebladder dissection

    Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy

06

What researchers measure

Primary outcomes

  1. Operative time

    of whole cs

    Time frame: icluding all cs over the period of one year

  2. Blood loss

    through counting soaked towels and weighting them before and after being soaked considering the difference in grams as the calculated blood loss and calculating blood in the suction reservoir and comparing pre and post operative Hb level also haemotacrit level and number of units of packed RBCs transfused

    Time frame: icluding all cs over the period of one year

  3. - Incidence of urological

    - Incidence of urological injuries discovered intraoperative and procedure needed to repair or as a late complication as fistula formation.

    Time frame: during cs and post operative delayed complication icluding all cs over the period of one year

Secondary outcomes

  1. Neonatal APGAR score

    Neonatal APGAR score

    Time frame: after delivery of the baby during the 1st 15 minutes

  2. Time taken to create bladder flap

    from the start of bladder dissection

    Time frame: from the start of bladder dissection icluding all cs over the period of one year

  3. 3 months post operative filling cystometry

    3 months post operative filling cystometry

    Time frame: 3 months post operative

07

Study locations

1 of 1 sites recruiting
  • Ain Shams University Maternity Hospital
    Cairo, 02, Egypt
    • Amr Elshalakany, Prof · Contact
    • hassan helmy, master · Sub investigator
    • Amr EL-Shalakany, prof · Sub investigator
    • tamer borg, prof · Sub investigator
    • mohamed elsenity, MD · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: Yes

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 Sep 19, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03676855
Lead sponsor
Ain Shams University
Responsible party
Mohamed abd elfatah elsenity (Lecturer of obs and gyn atainshams university, Ain Shams University) — Principal investigator
First posted
Sep 19, 2018
Start date
Mar 31, 2018
Primary completion
Feb 1, 2019 (estimated)
Completion
Mar 31, 2019 (estimated)
Last update
Sep 19, 2018

Study contacts

hassan helmy, master
Contact
saberaleek2222@yahoo.com
01023308711
mohamed elsenity, MD
Contact
01226573332

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 status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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