Conservative Management of Placenta Accreta Spectrum

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 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.

Study Overview

• Status: Completed
• Conditions: Placenta Accreta; Post Partum Hemorrhage; Blood Loss Massive
• Intervention / Treatment: Procedure: conservative surgery for placenta accreta spectrum

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. 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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Tunisia
  • Tunis
    • Manouba, Tunis, Tunisia, 2010
      • Haithem Aloui

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All parturients with suspected placenta accreta either on MRI if the C section is scheduled or on Ultrasound if an emmergent delivery is set

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No signs of Placenta Accreta Spectrum upon artificial delivery

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
conservative surgery; resective-constructive surgery: the excision of the placenta and its attachment site on the myometrium. Subsequently, uterine reconstruction is undertaken.	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.
hysterectomy 1; Standard hysterectomy is performed
hysterectomy 2; Standard hysterectomy is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss	Blood spoliation during procedure	peroperatively
Transfusion requirements	Number of red blood cells units transfused	First 24 hours
Hemoglobin variation	The difference between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure	First 24 hours]
Procedure duration	Time needed to perform surgery from incision to skin closure	peroperatively
Intensive care transfer rate	Intensive care transfer following surgery for placenta accreta	first 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Clotting disorders	Assessed by the incidence of Intravascular disseminated coagulopathy	time from surgery up to 30 days postoperative
Bladder wound	Incidence of accidental bladder damage	Time from surgery up to 30 days postoperative
Digestive wound	Incidence of accidental digestive lesion	Time from surgery up to 30 days postoperative

Collaborators and Investigators

• Sponsor: Tunis University
• Collaborators: University Tunis El Manar
• Investigators: Study Chair: Ben Marzouk Maghrebi, Professor, Tunis University Manar

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2020
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Placenta accreta; Conservative management; Uncontrolled hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Puerperal Disorders; Uterine Hemorrhage; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Postpartum Hemorrhage; Placenta Accreta
• Other Study ID Numbers: CMNT PAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No