Conservative Management of Placenta Accreta Spectrum

Placenta Accreta Clinical Trial

Official title:

Surgical Conservative Management of Placenta Accreta Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06253832
• Other study ID #: CMNT PAS
• Status: Completed
• Start date: January 4, 2020
• Est. completion date: January 30, 2024

Study information

• Verified date: February 2024
• Source: Tunis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

A prospective single-center study conducted from January 4, 2020, to August 17, 2022, at the Tunisian maternity center included cases of placenta accreta and increta, excluding placenta percreta. Data on operative metrics, complications, transfusions, and ICU admissions were recorded. Diagnosis of placenta accreta spectrum (PAS) relied on imaging and histopathology, with exclusion criteria applied. Surgeons attained proficiency through supervised surgeries. Blood loss calculation incorporated total blood volume and hematocrit changes.

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. Placenta percreta is not addressed in this procedure. The JJ probe is removed post-surgery, and hemostasis is ensured through the modified B-Lynch suturing technique. Postoperative bladder assessment is conducted using a physiological serum.

The prospective single-center study spanned from January 4, 2020, to August 17, 2022, encompassing the maternity and neonatology center in Tunis. Placentas diagnosed with accreta and increta were included, while cases of placenta percreta were excluded.

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 formulated illustrative diagrams of the employed surgical method.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 30, 2024
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No signs of Placenta Accreta Spectrum upon artificial delivery

Related Conditions & MeSH terms

• Blood Loss Massive
• Hemorrhage
• Placenta Accreta
• Post Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Procedure:
• conservative surgery for placenta accreta spectrum
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.

Locations

Country	Name	City	State
Tunisia	Haithem Aloui	Manouba	Tunis

Sponsors (2)

Lead Sponsor	Collaborator
Tunis University	University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated blood loss	Blood spoliation during procedure	peroperatively
Primary	Hemoglobin variation	The difference between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure	First 24 hours]
Primary	Transfusion requirements	Number of red blood cells units transfused	First 24 hours
Primary	Procedure duration	Time needed to perform surgery from incision to skin closure	peroperatively
Primary	Intensive care transfer rate	Intensive care transfer following surgery for placenta accreta	first 24 hours
Secondary	Length of stay in ICU	duration of the stay in the ICU following surgery for placenta accreta	time from surgery up to 30 days postoperative
Secondary	Clotting disorders	Assessed by the incidence of Intravascular disseminated coagulopathy	time from surgery up to 30 days postoperative
Secondary	Bladder wound	Incidence of accidental bladder damage	Time from surgery up to 30 days postoperative
Secondary	Digestive wound	Incidence of accidental digestive lesion	Time from surgery up to 30 days postoperative