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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Tunisia1 site
  • Haithem Aloui

    Manouba, Tunis Governorate, 2010

Other trials in Tunisia

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:

  1. Establishing the Significance Level (Alpha): Set at 0.05 to ensure 95% confidence.
  2. Selecting the Study\'s Power (1 - Beta): Predetermined at 90%.
  3. Assessing the Standard Deviations of Both Groups: Derived from pilot study data.
  4. 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.

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 groups in NCT06253832
Study groupRoleWhat they receive
conservative surgeryExperimentalresective-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 1Active comparatorStandard hysterectomy is performed
Receives: Procedure: hysterectomy
hysterectomy 2Active comparatorStandard hysterectomy is performed
Receives: Procedure: hysterectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimated blood loss

    Blood spoliation during procedure

    Measured: peroperatively

  2. Hemoglobin variation

    The difference between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure

    Measured: First 24 hours]

  3. Transfusion requirements

    Number of red blood cells units transfused

    Measured: First 24 hours

  4. Procedure duration

    Time needed to perform surgery from incision to skin closure

    Measured: peroperatively

  5. Intensive care transfer rate

    Intensive care transfer following surgery for placenta accreta

    Measured: first 24 hours

Secondary outcomes (4)
  1. 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

  2. Clotting disorders

    Assessed by the incidence of Intravascular disseminated coagulopathy

    Measured: time from surgery up to 30 days postoperative

  3. Bladder wound

    Incidence of accidental bladder damage

    Measured: Time from surgery up to 30 days postoperative

  4. 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.

  1. First posted12 Feb 2024
  2. Study start4 Jan 2020
  3. Primary completion17 Aug 2022
  4. Study completion30 Jan 2024

Resources

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)
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

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.

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