Morbidly Adherent PlacentaNCT03676855
Comparison Between Bladder Dissection Before and After Uterine Incision in Cesarean Section for Morbidly Adherent Placenta
A study testing bladder dissection in people with Morbidly Adherent Placenta, run by Ain Shams University at 1 site in Egypt.
Trial summary
Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Morbidly Adherent Placenta
- What is being tested?
- bladder dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Mar 2018to 31 Mar 2019
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with BMI at or under 35 Kg/m2.
- Women having previous two cesarean section or more.
- Women with gestational age more than 32 weeks with viable fetus.
- Women with any degree of placenta previa .
- Patient with morbidly adherent placenta on cesarean scar only.
Who cannot join
- Patient who are haemodynamically unstable before skin incision.
- Patient with clinically evident intraamniotic infection.
- Patient with previous history of bladder injury .
Trial locations and contacts
1 site in 1 country.
mohamed elsenity, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Maternity Hospital
Cairo, 02
Amr Elshalakany, Prof
hassan helmy, master
About this study
Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy
- Conditions
- Morbidly Adherent Placenta
- Being tested
- bladder dissection
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bladder dissectionProcedure or surgery
Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| bladder dissection before uterine incision | Active comparator | Not described Receives: Procedure: bladder dissection |
| bladder dissection after uterine incision | Experimental | Not described Receives: Procedure: bladder dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
of whole cs
Measured: icluding all cs over the period of one year
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
Measured: icluding all cs over the period of one year
- Incidence of urological
- Incidence of urological injuries discovered intraoperative and procedure needed to repair or as a late complication as fistula formation.
Measured: during cs and post operative delayed complication icluding all cs over the period of one year
Secondary outcomes (3)
Neonatal APGAR score
Neonatal APGAR score
Measured: after delivery of the baby during the 1st 15 minutes
Time taken to create bladder flap
from the start of bladder dissection
Measured: from the start of bladder dissection icluding all cs over the period of one year
3 months post operative filling cystometry
3 months post operative filling cystometry
Measured: 3 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start31 Mar 2018
- Primary completion1 Feb 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbidly Adherent PlacentaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed abd elfatah elsenity, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676855
- Sponsor's protocol ID
- FWA000017585MD361/2017
- Status last verified
- Sep 2018
- First submitted
- 26 Aug 2018
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Bladder Dissection Before and After Uterine Incision in Cesarean Section for Morbidly Adherent Placenta
- ClinicalTrials.gov ID
- NCT03676855
- Acronym / sponsor ID
- FWA000017585MD361/2017
- Conditions
- Morbidly Adherent Placenta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 31 Mar 2018 (actual)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 19 Sep 2018 (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.
Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bladder dissection before uterine incision | Active comparator | Procedure: bladder dissection |
| bladder dissection after uterine incision | Experimental | Procedure: bladder dissection |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with BMI at or under 35 Kg/m2.
- Women having previous two cesarean section or more.
- Women with gestational age more than 32 weeks with viable fetus.
- Women with any degree of placenta previa .
- Patient with morbidly adherent placenta on cesarean scar only.
Key exclusion criteria (3 listed)
- Patient who are haemodynamically unstable before skin incision.
- Patient with clinically evident intraamniotic infection.
- Patient with previous history of bladder injury .
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 |
|---|---|---|
| bladder dissectionComparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy | Procedure or surgery | bladder dissection after uterine incision, bladder dissection before uterine incision |
Primary outcome
Operative time
Time frame: icluding all cs over the period of one year
of whole cs
Blood loss
Time frame: icluding all cs over the period of one year
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
- Incidence of urological
Time frame: during cs and post operative delayed complication icluding all cs over the period of one year
- Incidence of urological injuries discovered intraoperative and procedure needed to repair or as a late complication as fistula formation.
3 secondary outcomes
Neonatal APGAR score
Time frame: after delivery of the baby during the 1st 15 minutes
Time taken to create bladder flap
Time frame: from the start of bladder dissection icluding all cs over the period of one year
3 months post operative filling cystometry
Time frame: 3 months post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2018.
- Individual participant dataSharing planned: Yes
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.
mohamed elsenity, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bladder dissection in people with Morbidly Adherent Placenta, run by Ain Shams 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hassan helmy, master (01023308711, saberaleek2222@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: icluding all cs over the period of one year). The study lists 3 primary outcomes in all. 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 19 Sep 2018.