Placenta AccretaNCT04210479
Comparison of Bladder Filling vs. Non-Filling in Cesarean Hysterectomy for Placenta Percreta
A study testing Filled-bladder and non filled-bladder in people with Placenta Accreta, run by Hatem AbuHashim.
Trial summary
The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Filled-bladder and non filled-bladder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2020to 30 Jun 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 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women in their third trimester (35-37 W).
- Placenta previa accreta spectrum identified by the Ultrasound (low lying anterior or major degree anterior).
- With at least one prior cesarean section.
- Elective cesarean hysterectomy.
- Evidence of gross placental invasion at the time of surgery (FIGO grade 3a.
Who cannot join
- Patients undergoing conservative treatment.
- Emergency cesarean hysterectomy.
- No evidence of gross placental invasion at the time of surgery.
- Posterior placenta.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bladder Filling in Cesarean Hysterectomy for Placenta Percreta: A Randomized Trial
The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates. including less blood loss, fewer transfusion requirements and, intraoperative urinary tract injury as well as improve fetal outcome.
Ultrasound evaluation is the recommended first-line modality for diagnosing PAS. Ultrasound features suggestive of PAS include loss of the normal retroplacental clear zone, attenuation of the uterine-bladder interface, reduced retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder. A systematic review reported that the antenatal diagnosis of PAS significantly lowered the rate of urinary tract injury (from 63% to 39%) during cesarean hysterectomies in these cases.
Unlike other elective cesarean hysterectomies, cesarean hysterectomy with a placenta previa increta/percreta, is more difficult. There is a greater need to both keep a margin from the vascular cervical-placental mass and simultaneously protect the urinary bladder. Case series reported that bladder filling helps the surgeon to more clearly identify the planes of dissection and secure the engorged aberrant vessels, thereby reduces bladder injury. Accordingly, a prospective randomized study in pregnant patients with placenta previa increta/percreta undergoing elective cesarean hysterectomy will be conducted to address this important issue.
- Conditions
- Placenta Accreta
- Being tested
- Filled-bladder, non filled-bladder
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Filled-bladderProcedure or surgery
Urinary bladder filling with 300 ml diluted methylene blue
non filled-bladderProcedure or surgery
Pull up the empty (non-filled) urinary bladder using Allis forceps
| Study group | Role | What they receive |
|---|---|---|
| Filled-bladder | Experimental | Bladder filling with 300ml diluted methylene blue. Receives: Procedure: Filled-bladder |
| non filled-bladder | Active comparator | Not described Receives: Procedure: non filled-bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of urinary bladder injury
Unintentional bladder injury during elective cesarean hysterectomy
Measured: Intra-operative (i.e. during surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start15 Jan 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placenta AccretaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hatem AbuHashim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatem AbuHashim, Mansoura University
- Investigators
- Hatem Abu Hashim, MD. FRCOG. PhD, Study chair, Faculty of Medicine, Mansoura UniversityMostafa Aboelenin, MBBCh, Principal investigator, Samnoud General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210479
- Sponsor's protocol ID
- MS.19.12.939
- Status last verified
- Dec 2019
- First submitted
- 21 Dec 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Matsubara S. Caesarean hysterectomy for placenta praevia accreta: filling the bladder technique to identify an appropriate bladder separation site. J Obstet Gynaecol. 2013 Feb;33(2):163-4. doi: 10.3109/01443615.2012.740525. No abstract available.
PubMed 23445140
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bladder Filling in Cesarean Hysterectomy for Placenta Percreta: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04210479
- Acronym / sponsor ID
- MS.19.12.939
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Hatem AbuHashimUniversity, hospital or other
- Study start
- 15 Jan 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 24 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.
The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates. including less blood loss, fewer transfusion requirements and, intraoperative urinary tract injury as well as improve fetal outcome.
Ultrasound evaluation is the recommended first-line modality for diagnosing PAS. Ultrasound features suggestive of PAS include loss of the normal retroplacental clear zone, attenuation of the uterine-bladder interface, reduced retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder. A systematic review reported that the antenatal diagnosis of PAS significantly lowered the rate of urinary tract injury (from 63% to 39%) during cesarean hysterectomies in these cases.
Unlike other elective cesarean hysterectomies, cesarean hysterectomy with a placenta previa increta/percreta, is more difficult. There is a greater need to both keep a margin from the vascular cervical-placental mass and simultaneously protect the urinary bladder. Case series reported that bladder filling helps the surgeon to more clearly identify the planes of dissection and secure the engorged aberrant vessels, thereby reduces bladder injury. Accordingly, a prospective randomized study in pregnant patients with placenta previa increta/percreta undergoing elective cesarean hysterectomy will be conducted to address this important issue.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filled-bladder | Experimental | Procedure: Filled-bladderBladder filling with 300ml diluted methylene blue. |
| non filled-bladder | Active comparator | Procedure: non filled-bladder |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant women in their third trimester (35-37 W).
- Placenta previa accreta spectrum identified by the Ultrasound (low lying anterior or major degree anterior).
- With at least one prior cesarean section.
- Elective cesarean hysterectomy.
- Evidence of gross placental invasion at the time of surgery (FIGO grade 3a.
Key exclusion criteria (4 listed)
- Patients undergoing conservative treatment.
- Emergency cesarean hysterectomy.
- No evidence of gross placental invasion at the time of surgery.
- Posterior placenta.
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 |
|---|---|---|
| Filled-bladderUrinary bladder filling with 300 ml diluted methylene blue | Procedure or surgery | Filled-bladder |
| non filled-bladderPull up the empty (non-filled) urinary bladder using Allis forceps | Procedure or surgery | non filled-bladder |
Primary outcome
Rate of urinary bladder injury
Time frame: Intra-operative (i.e. during surgery).
Unintentional bladder injury during elective cesarean hysterectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Results publication: PubMed 23445140Matsubara S. Caesarean hysterectomy for placenta praevia accreta: filling the bladder technique to identify an appropriate bladder separation site. J Obstet Gynaecol. 2013 Feb;33(2):163-4. doi: 10.3109/01443615.2012.740525. No abstract available.
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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.
Hatem Abu Hashim, MD. FRCOG. PhD study chair
Faculty of Medicine, Mansoura University
Mostafa Aboelenin, MBBCh principal investigator
Samnoud General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Filled-bladder and non filled-bladder in people with Placenta Accreta, run by Hatem AbuHashim.
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 4 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 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Hatem Abu Hashim, MD.FRCOG.PhD (+20502300002, hatem_ah@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of urinary bladder injury (time frame: Intra-operative (i.e. during surgery).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210479, which also lists 1 linked publication.
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 24 Dec 2019.