Clinical trial NCT06253832: Conservative Management of Placenta Accreta Spectrum
Official title: Surgical Conservative Management of Placenta Accreta Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Accreta
Post Partum Hemorrhage
Blood Loss Massive
Keywords: Placenta accreta
Conservative management
Uncontrolled hemorrhage
Lead sponsor: Tunis University
Sponsor class: OTHER
Collaborators: name: University Tunis El Manar
First posted: 2024-02-12
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparer le traitement conservateur chirurgical à l'hystérectomie dans le traitement du placenta accreta
Primary purpose: TREATMENT

Brief 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.

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:

1. Establishing the Significance Level (Alpha): Set at 0.05 to ensure 95% confidence.
2. Selecting the Study\&#39;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 \&#34;conservative surgical treatment\&#34; group was compared with two \&#34;hysterectomy\&#34; groups, sharing similar characteristics.

Description of Surgical Technique:

Our team has developed illustrative photos of the surgical method used as well as videos.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing scheduled or emergency cesarean section for placenta accreta

Exclusion Criteria:

* No signs of Placenta Accreta Spectrum upon artificial delivery

Primary outcomes:
measure: Estimated blood loss
timeFrame: peroperatively
measure: Hemoglobin variation
timeFrame: First 24 hours]
measure: Transfusion requirements
timeFrame: First 24 hours
measure: Procedure duration
timeFrame: peroperatively
measure: Intensive care transfer rate
timeFrame: first 24 hours
Secondary outcomes:
measure: Length of stay in ICU
timeFrame: time from surgery up to 30 days postoperative
measure: Clotting disorders
timeFrame: time from surgery up to 30 days postoperative
measure: Bladder wound
timeFrame: Time from surgery up to 30 days postoperative
measure: Digestive wound
timeFrame: Time from surgery up to 30 days postoperative
Other outcomes:
Locations:
city: Manouba
country: Tunisia
facility: Haithem Aloui
state: Tunis
Study officials:
affiliation: Tunis University Manar
name: Ben Marzouk Maghrebi, Professor
role: STUDY_CHAIR
References: