Placenta AccretaNCT06253832
Conservative Management of Placenta Accreta Spectrum
A study testing conservative surgery for placenta accreta spectrum and hysterectomy in people with Placenta Accreta and Post Partum Hemorrhage, run by Tunis University at 1 site in Tunisia.
Trial summary
The resective-constructive surgery, detailed in prior research by Palacios-Jaraquemada JM, involves excising the placenta and its attachment on the myometrium, with modifications including the systematic use of a double JJ probe, omitting arterial ligation, and prioritizing careful dissection and reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Placenta Accreta, Post Partum Hemorrhage, Blood Loss Massive
- What is being tested?
- conservative surgery for placenta accreta spectrum and hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTunisia
- Study dates
- 4 Jan 2020to 30 Jan 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing scheduled or emergency cesarean section for placenta accreta
Who cannot join
- No signs of Placenta Accreta Spectrum upon artificial delivery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Conservative Management of Placenta Accreta Disorders
The resective-constructive surgery, detailed in prior research by Palacios-Jaraquemada JM, involves excising the placenta and its attachment on the myometrium, with modifications including the systematic use of a double JJ probe, omitting arterial ligation, and prioritizing careful dissection and reconstruction.
A prospective single-center study conducted from January 4, 2020 to February 2, 2024, at the Tunisian maternity ward including cases of placenta accreta, increta and percreta. Data on the estimation of blood loss, complications, transfusions and intensive care admissions were recorded. Diagnosis of placenta accreta was based on imaging and histopathology. The blood loss calculation incorporates total blood volume and changes in hematocrit.
Read the detailed description
The surgical procedure known as resective-constructive surgery involves the excision of the placenta and its attachment site on the myometrium. This method has been detailed in prior research by Palacios-Jaraquemada JM, upon which we have built with some modifications.
Our modifications include the systematic placement of a double JJ probe under spinal anesthesia, omitting the ligation of hypogastric arteries or uterine arteries. Cesarean sections are performed at 37 weeks of gestational age. We prioritize ligating newly formed blood vessels between the uterus and surrounding structures, carefully dissecting the bladder, performing hysterotomy, and meticulously removing the placenta and its insertion bed until reaching healthy tissues. Subsequently, uterine reconstruction is undertaken.
Placental boundaries are identified through extrauterine palpation, followed by a transverse hysterotomy. Intrauterine palpation delineates the inferior margins of the placenta, guiding the resection of the placental bed. Closure is achieved through hysterorrhaphy. The JJ probe is removed post-surgery, and hemostasis is ensured through the modified B-Lynch suturing technique.
The prospective single-center study spanned from January 4, 2020, to February 2, 2024, encompassing the maternity and neonatology center in Tunis.
Data pertaining to operative time, blood loss, operative complications (such as organ or vessel injury), and postoperative complications (both early and late) were documented. Additionally, the success of the technique, units of blood transfusion administered, and admissions to the intensive care unit (ICU) were meticulously recorded.
Suspicion of placenta accreta was initially raised through pelvic MRI and ultrasonography. PAS was confirmed in all enrolled patients based on clinical history, image analysis (including ultrasound, Doppler, and MRI), and histopathological confirmation.
Patients lacking an intrasurgical or histopathological diagnosis of PAS were excluded from the statistical analysis.
Proficiency in the surgical technique, incorporating specialized hemostasis and dissection maneuvers, was attained by senior obstetricians who participated in 5-7 surgeries before independently managing cases. This approach aimed to ensure the initial reproducibility of the methodology.
The calculation of blood loss took into consideration the total blood volume (TBV), pre-partum hematocrit, and post-partum hematocrit, using the following formulas :
- Total Calculated Blood Loss (in milliliters of red blood cells) = Total blood volume * Percentage of blood loss
- Total Blood Volume = 0.75 x {[height (in inches) x 50] + [weight (in pounds) x 25]}
- Percentage of Blood Loss = (pre-partum hematocrit - post-partum hematocrit) / pre-partum hematocrit.
This approach ensured accurate assessment of blood loss during the procedures.
Sample Size:
In determining the sample size for our study, we employed a statistical formula applicable in the context of comparing mean values across two distinct groups, namely the experimental and control groups. This calculation is rooted in the t-test for independent samples.
The process entails the following critical steps:
- Establishing the Significance Level (Alpha): Set at 0.05 to ensure 95% confidence.
- Selecting the Study\'s Power (1 - Beta): Predetermined at 90%.
- Assessing the Standard Deviations of Both Groups: Derived from pilot study data.
- Identifying the Minimum Clinically Significant Difference (Delta): This represents the smallest difference we aim to detect in our study.
Pilot Study:
Initially, a pilot study was conducted to ascertain the standard deviations of the two groups and to gain an insight into the expected minimum difference.
Main Study:
Post-pilot study, we estimated the sample size. The \"conservative surgical treatment\" group was compared with two \"hysterectomy\" groups, sharing similar characteristics.
Description of Surgical Technique:
Our team has developed illustrative photos of the surgical method used as well as videos.
- Conditions
- Placenta Accreta, Post Partum Hemorrhage, Blood Loss Massive
- Being tested
- conservative surgery for placenta accreta spectrum, hysterectomy
- Keywords
- Placenta accreta, Conservative management, Uncontrolled hemorrhage
- Medical subject headings
- Placenta Accreta, Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conservative surgery for placenta accreta spectrumProcedure or surgery
The surgical procedure involved a midline incision for the laparotomy approach. Dissection of the uterus from the posterior bladder wall extended down to the cervix, with coagulation of the vesicouterine vessels. Hysterotomy was executed in the upper segment, just above the area of myometrial invasion. Hemostasis of the lower uterus was achieved through either square compression sutures or ligation of the colpouterine vessels. A conservative approach to uterine surgery was considered viable only under conditions of stable hemodynamics and when at least 2 cm of healthy myometrium was visibly intact above the cervix. For cases involving conservative resection, all myometrium affected by invasion and the entire placenta were excised. Subsequently, the uterus was reconstructed using a continuous stitching technique.
hysterectomyProcedure or surgery
hysterectomy for placenta accreta spectrum
hysterectomyProcedure or surgery
hysterectomy for placenta accreta spectrum
| Study group | Role | What they receive |
|---|---|---|
| conservative surgery | Experimental | resective-constructive surgery: the excision of the placenta and its attachment site on the myometrium. Subsequently, uterine reconstruction is undertaken. Receives: Procedure: conservative surgery for placenta accreta spectrum |
| hysterectomy 1 | Active comparator | Standard hysterectomy is performed Receives: Procedure: hysterectomy |
| hysterectomy 2 | Active comparator | Standard hysterectomy is performed Receives: Procedure: hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss
Blood spoliation during procedure
Measured: peroperatively
Hemoglobin variation
The difference between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure
Measured: First 24 hours]
Transfusion requirements
Number of red blood cells units transfused
Measured: First 24 hours
Procedure duration
Time needed to perform surgery from incision to skin closure
Measured: peroperatively
Intensive care transfer rate
Intensive care transfer following surgery for placenta accreta
Measured: first 24 hours
Secondary outcomes (4)
Length of stay in ICU
duration of the stay in the ICU following surgery for placenta accreta
Measured: time from surgery up to 30 days postoperative
Clotting disorders
Assessed by the incidence of Intravascular disseminated coagulopathy
Measured: time from surgery up to 30 days postoperative
Bladder wound
Incidence of accidental bladder damage
Measured: Time from surgery up to 30 days postoperative
Digestive wound
Incidence of accidental digestive lesion
Measured: Time from surgery up to 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start4 Jan 2020
- Primary completion17 Aug 2022
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- comparer le traitement conservateur chirurgical à l'hystérectomie dans le traitement du placenta accreta
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Collaborators
- University Tunis El Manar
- Responsible party
- Principal investigator, Haithem Aloui, Tunis University
- Investigators
- Ben Marzouk Maghrebi, Professor, Study chair, Tunis University Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253832
- Sponsor's protocol ID
- CMNT PAS
- Status last verified
- Sep 2024
- First submitted
- 2 Feb 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Conservative Management of Placenta Accreta Disorders
- ClinicalTrials.gov ID
- NCT06253832
- Acronym / sponsor ID
- CMNT PAS
- Conditions
- Placenta Accreta, Post Partum Hemorrhage, Blood Loss Massive
- Keywords
- Placenta accreta, Conservative management, Uncontrolled hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Collaborators
- University Tunis El Manar
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 12 Feb 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.
The resective-constructive surgery, detailed in prior research by Palacios-Jaraquemada JM, involves excising the placenta and its attachment on the myometrium, with modifications including the systematic use of a double JJ probe, omitting arterial ligation, and prioritizing careful dissection and reconstruction.
A prospective single-center study conducted from January 4, 2020 to February 2, 2024, at the Tunisian maternity ward including cases of placenta accreta, increta and percreta. Data on the estimation of blood loss, complications, transfusions and intensive care admissions were recorded. Diagnosis of placenta accreta was based on imaging and histopathology. The blood loss calculation incorporates total blood volume and changes in hematocrit.
Detailed description
The surgical procedure known as resective-constructive surgery involves the excision of the placenta and its attachment site on the myometrium. This method has been detailed in prior research by Palacios-Jaraquemada JM, upon which we have built with some modifications.
Our modifications include the systematic placement of a double JJ probe under spinal anesthesia, omitting the ligation of hypogastric arteries or uterine arteries. Cesarean sections are performed at 37 weeks of gestational age. We prioritize ligating newly formed blood vessels between the uterus and surrounding structures, carefully dissecting the bladder, performing hysterotomy, and meticulously removing the placenta and its insertion bed until reaching healthy tissues. Subsequently, uterine reconstruction is undertaken.
Placental boundaries are identified through extrauterine palpation, followed by a transverse hysterotomy. Intrauterine palpation delineates the inferior margins of the placenta, guiding the resection of the placental bed. Closure is achieved through hysterorrhaphy. The JJ probe is removed post-surgery, and hemostasis is ensured through the modified B-Lynch suturing technique.
The prospective single-center study spanned from January 4, 2020, to February 2, 2024, encompassing the maternity and neonatology center in Tunis.
Data pertaining to operative time, blood loss, operative complications (such as organ or vessel injury), and postoperative complications (both early and late) were documented. Additionally, the success of the technique, units of blood transfusion administered, and admissions to the intensive care unit (ICU) were meticulously recorded.
Suspicion of placenta accreta was initially raised through pelvic MRI and ultrasonography. PAS was confirmed in all enrolled patients based on clinical history, image analysis (including ultrasound, Doppler, and MRI), and histopathological confirmation.
Patients lacking an intrasurgical or histopathological diagnosis of PAS were excluded from the statistical analysis.
Proficiency in the surgical technique, incorporating specialized hemostasis and dissection maneuvers, was attained by senior obstetricians who participated in 5-7 surgeries before independently managing cases. This approach aimed to ensure the initial reproducibility of the methodology.
The calculation of blood loss took into consideration the total blood volume (TBV), pre-partum hematocrit, and post-partum hematocrit, using the following formulas :
- Total Calculated Blood Loss (in milliliters of red blood cells) = Total blood volume * Percentage of blood loss
- Total Blood Volume = 0.75 x {[height (in inches) x 50] + [weight (in pounds) x 25]}
- Percentage of Blood Loss = (pre-partum hematocrit - post-partum hematocrit) / pre-partum hematocrit.
This approach ensured accurate assessment of blood loss during the procedures.
Sample Size:
In determining the sample size for our study, we employed a statistical formula applicable in the context of comparing mean values across two distinct groups, namely the experimental and control groups. This calculation is rooted in the t-test for independent samples.
The process entails the following critical steps:
- Establishing the Significance Level (Alpha): Set at 0.05 to ensure 95% confidence.
- Selecting the Study\'s Power (1 - Beta): Predetermined at 90%.
- Assessing the Standard Deviations of Both Groups: Derived from pilot study data.
- Identifying the Minimum Clinically Significant Difference (Delta): This represents the smallest difference we aim to detect in our study.
Pilot Study:
Initially, a pilot study was conducted to ascertain the standard deviations of the two groups and to gain an insight into the expected minimum difference.
Main Study:
Post-pilot study, we estimated the sample size. The \"conservative surgical treatment\" group was compared with two \"hysterectomy\" groups, sharing similar characteristics.
Description of Surgical Technique:
Our team has developed illustrative photos of the surgical method used as well as videos.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- comparer le traitement conservateur chirurgical à l'hystérectomie dans le traitement du placenta accreta
| Arm | Type | Receives |
|---|---|---|
| conservative surgery | Experimental | Procedure: conservative surgery for placenta accreta spectrumresective-constructive surgery: the excision of the placenta and its attachment site on the myometrium. Subsequently, uterine reconstruction is undertaken. |
| hysterectomy 1 | Active comparator | Procedure: hysterectomyStandard hysterectomy is performed |
| hysterectomy 2 | Active comparator | Procedure: hysterectomyStandard hysterectomy is performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing scheduled or emergency cesarean section for placenta accreta
Key exclusion criteria (1 listed)
- No signs of Placenta Accreta Spectrum upon artificial delivery
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 |
|---|---|---|
| conservative surgery for placenta accreta spectrumThe surgical procedure involved a midline incision for the laparotomy approach. Dissection of the uterus from the posterior bladder wall extended down to the cervix, with coagulation of the vesicouterine vessels. Hysterotomy was executed in the upper segment, just above the area of myometrial invasion. Hemostasis of the lower uterus was achieved through either square compression sutures or ligation of the colpouterine vessels. A conservative approach to uterine surgery was considered viable only under conditions of stable hemodynamics and when at least 2 cm of healthy myometrium was visibly intact above the cervix. For cases involving conservative resection, all myometrium affected by invasion and the entire placenta were excised. Subsequently, the uterus was reconstructed using a continuous stitching technique. | Procedure or surgery | conservative surgery |
| hysterectomyhysterectomy for placenta accreta spectrum | Procedure or surgery | hysterectomy 1 |
| hysterectomyhysterectomy for placenta accreta spectrum | Procedure or surgery | hysterectomy 2 |
Primary outcome
Estimated blood loss
Time frame: peroperatively
Blood spoliation during procedure
Hemoglobin variation
Time frame: First 24 hours]
The difference between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure
Transfusion requirements
Time frame: First 24 hours
Number of red blood cells units transfused
Procedure duration
Time frame: peroperatively
Time needed to perform surgery from incision to skin closure
Intensive care transfer rate
Time frame: first 24 hours
Intensive care transfer following surgery for placenta accreta
4 secondary outcomes
Length of stay in ICU
Time frame: time from surgery up to 30 days postoperative
Clotting disorders
Time frame: time from surgery up to 30 days postoperative
Bladder wound
Time frame: Time from surgery up to 30 days postoperative
Digestive wound
Time frame: Time from surgery up to 30 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
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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.
Ben Marzouk Maghrebi, Professor study chair
Tunis University Manar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conservative surgery for placenta accreta spectrum and hysterectomy in people with Placenta Accreta and Post Partum Hemorrhage, run by Tunis University at 1 site in Tunisia.
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 1 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 Tunisia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated blood loss (time frame: peroperatively). The study lists 5 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 2024.