Placenta AccretaNCT06575023
Tamponade vs Partial Myometrial Resection of Lower Uterine Segment in Management of Placenta Accreta Spectrum Cases
A study testing Tamponade of lower uterine segment in management of placenta accreta spectrum cases and partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases in people with Placenta Accreta, run by Assiut University.
Trial summary
To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum . Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- Tamponade of lower uterine segment in management of placenta accreta spectrum cases and partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1-Pregnant women with placenta previa /PAS diagnosed before delivery (by ultrasound and Doppler examination) .
- 2 - Gestational age starting from 28 weeks onwards. 3- Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy) 4- Elective or emergent Caesarean deliveries
Who cannot join
- A pre-existing decision of performing intrapartum hysterectomy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Esraa Badran, assistant professor contact
About this study
To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum .
Read the detailed description
Placenta accreta spectrum (PAS) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium (1-2). Over the last 40 years, caesarean delivery rates around the world have risen from less than 10% to over 30%, and almost simultaneously a 10-fold increase in the incidence of PAS (3). PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality (4).
Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally. There is also wide variation globally on the management of PAS disorders, with some centres opting for a radical approach, whereas others have proposed a range of conservative approaches (5).
The conservative approaches include one-step conservative surgery, leaving the placenta in situ, the Triple-P procedure, and transverse B-Lynch suture (1). Several techniques have been described for controlling massive bleeding associated with placenta previa caesarean sections ,including uterine packing with gauze ,balloon tamponades ,the B-Lynch suture,insertion of parallel vertical compression sutures, a square suturing technique and embolization or ligation of the uterine and internal iliac arteries , but there is awide variation in the success rate of these maneuvers. Over-sewing of the bleeding site is the most common procedure used for PPH management, but in many cases, the bleeding points located in the lower segment and cervical canal are too deep and their locations are unclear because of the severity of the bleeding(
- Conditions
- Placenta Accreta
- Being tested
- Tamponade of lower uterine segment in management of placenta accreta spectrum cases, partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamponade of lower uterine segment in management of placenta accreta spectrum casesProcedure or surgery
To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum
partial myometrial resection of lower uterine segment in management of placenta accreta spectrum casesProcedure or surgery
tamponade vs partial myomertial resection of lower uterine segment in managment of placenta accreta spectrum cases
| Study group | Role | What they receive |
|---|---|---|
| tamponade of lower uterine segmentin managment of placenta accreta spectrum cases | Active comparator | usage of tamponade of the lower uterine segment in managment of placnta accreta spectrum cases Receives: Procedure: Tamponade of lower uterine segment in management of placenta accreta spectrum cases |
| partial myometrial resection of lower uterine segment in management of placenta accreta spectrum | Active comparator | partial resection of lower uterine segment myometrium Receives: Procedure: partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of intraopertive blood loss.
compare of amount of blood loss between two methods by adding collected blood in suction apparatus in milliliters to amount of biood in the soaked towels
Measured: 2 years
Secondary outcomes (4)
ICU admission
yes or no admission number of days if there is ICU admission cause of admission
Measured: 2 years
Re exploration
if there is exploration or no cause of re-exploration outcome of re-exploration
Measured: 2 years
drop of HB level postoperative
result of substitution of HB level postoperative from preoperative in gmldl
Measured: 2 years
blood transfusion
amount of transfused blood units
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2027 (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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Nabil Abdelrahman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575023
- Sponsor's protocol ID
- management of placenta accreta
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sentilhes L, Goffinet F, Kayem G. Management of placenta accreta. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1125-34. doi: 10.1111/aogs.12222.
PubMed 23869630
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tamponade vs Partial Myometrial Resection of Lower Uterine Segment in Management of Placenta Accreta Spectrum Cases
- ClinicalTrials.gov ID
- NCT06575023
- Acronym / sponsor ID
- management of placenta accreta
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 28 Aug 2024 (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.
To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum .
Detailed description
Placenta accreta spectrum (PAS) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium (1-2). Over the last 40 years, caesarean delivery rates around the world have risen from less than 10% to over 30%, and almost simultaneously a 10-fold increase in the incidence of PAS (3). PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality (4).
Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally. There is also wide variation globally on the management of PAS disorders, with some centres opting for a radical approach, whereas others have proposed a range of conservative approaches (5).
The conservative approaches include one-step conservative surgery, leaving the placenta in situ, the Triple-P procedure, and transverse B-Lynch suture (1). Several techniques have been described for controlling massive bleeding associated with placenta previa caesarean sections ,including uterine packing with gauze ,balloon tamponades ,the B-Lynch suture,insertion of parallel vertical compression sutures, a square suturing technique and embolization or ligation of the uterine and internal iliac arteries , but there is awide variation in the success rate of these maneuvers. Over-sewing of the bleeding site is the most common procedure used for PPH management, but in many cases, the bleeding points located in the lower segment and cervical canal are too deep and their locations are unclear because of the severity of the bleeding(
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tamponade of lower uterine segmentin managment of placenta accreta spectrum cases | Active comparator | Procedure: Tamponade of lower uterine segment in management of placenta accreta spectrum casesusage of tamponade of the lower uterine segment in managment of placnta accreta spectrum cases |
| partial myometrial resection of lower uterine segment in management of placenta accreta spectrum | Active comparator | Procedure: partial myometrial resection of lower uterine segment in management of placenta accreta spectrum casespartial resection of lower uterine segment myometrium |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1-Pregnant women with placenta previa /PAS diagnosed before delivery (by ultrasound and Doppler examination) .
- 2 - Gestational age starting from 28 weeks onwards. 3- Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy) 4- Elective or emergent Caesarean deliveries
Key exclusion criteria (1 listed)
- A pre-existing decision of performing intrapartum hysterectomy
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 |
|---|---|---|
| Tamponade of lower uterine segment in management of placenta accreta spectrum casesTo compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum | Procedure or surgery | tamponade of lower uterine segmentin managment of placenta accreta spectrum cases |
| partial myometrial resection of lower uterine segment in management of placenta accreta spectrum casestamponade vs partial myomertial resection of lower uterine segment in managment of placenta accreta spectrum cases | Procedure or surgery | partial myometrial resection of lower uterine segment in management of placenta accreta spectrum |
Primary outcome
amount of intraopertive blood loss.
Time frame: 2 years
compare of amount of blood loss between two methods by adding collected blood in suction apparatus in milliliters to amount of biood in the soaked towels
4 secondary outcomes
ICU admission
Time frame: 2 years
Re exploration
Time frame: 2 years
drop of HB level postoperative
Time frame: 2 years
blood transfusion
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Results publication: PubMed 23869630Sentilhes L, Goffinet F, Kayem G. Management of placenta accreta. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1125-34. doi: 10.1111/aogs.12222.
- Individual participant dataSharing planned: Undecided
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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.
Esraa Badran, assistant professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Tamponade of lower uterine segment in management of placenta accreta spectrum cases and partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases in people with Placenta Accreta, run by Assiut University.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Nabil, master degree (nabilabdelrahman722@gmail.com, nabilabdelrahman722@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of intraopertive blood loss. (time frame: 2 years). 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 NCT06575023, 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 28 Aug 2024.