Conservative Management of Morbidly Adherent Anterior Situated Placenta

NCT04579172 | Completed

• 1 other identifier: MS.20.09.1246
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Placenta accreta is defined as abnormal trophoblast invasion of part or the entire placenta into the myometrium of the uterine wall. Placenta accreta spectrum (PAS), formerly known as morbidly adherent placenta, refers to the range of pathologic adherence of the placenta, including placenta increta, percreta, and accreta. An important risk factor of placenta accreta is placenta previa in the presence of a uterine scar. Placenta previa is an independent risk factor for placenta accreta.Additional reported risk factors for placenta accreta include increased maternal age and multiparity, other prior uterine surgery, prior uterine curettage,uterine irradiation, Asherman syndrome, uterine leiomyomata, uterine anomalies, hypertensive disorders of pregnancy and smoking. (1,2) Maternal morbidity and mortality can occur because of severe and sometimes life-threatening hemorrhage, which often requires blood transfusion also and rates of maternal death are increased for women with PAS. Additionally, patients with PAS are more likely to require hysterectomy at the time of delivery or during the postpartum period and have longer hospital stays states.(3) According to FIGO Classification of PAS Disorders 2019 There are three grades. Grade 1: abnormally adherent placenta (placenta adherent or accreta) - attached directly to the surface of the middle layer of the uterine wall (myometrium) without invading it, Grade 2: abnormally invasive placenta (increta) - invasion into the myometrium and Grade 3: abnormally invasive placenta (percreta) invasion may reach surrounding pelvic tissues, vessels and organs.(4) Nowadays, fertility sparing and conservative methods can be applied. These methods include placenta left in situ, cervical inversion technique , triple-P procedure, cervico-isthmic compression suture and anterior wall uterine resection

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

• estimated blood loss

  1. The amount of blood drawn into the storage jar during surgery (suction apparatus). 2. The weight of blood-soaked gauze pads, gauzes, and surgical dressings minus their preoperative weight, and corresponding conversion according to the proportion of 1.05 g in weight to 1 ml in volume.

  from the start of uterine incision till closure of uterine wall

Secondary Outcomes (2)

• hemoglobin deficit

  from the induction of anesthesia till 2 hours after the end of surgery

• complication rate

  from the start of induction of anesthesia till 24 hours after the end of surgery

Study Arms (2)

Group A

EXPERIMENTAL

Circular isthmic-cervical sutures

Procedure: Cervico- isthmic compression suture

Group B

EXPERIMENTAL

Resection of the infiltrated part of anterior uterine wall

Procedure: Anterior wall uterine resection:

Interventions

Cervico- isthmic compression suture PROCEDURE

Circular isthmic-cervical sutures will be applied . To avoid ureter and bladder injury, the bladder will be reflected downward. A silastic drain will be inserted into internal and through the external os , so as to drain the uterine cavity and to keep the cervical canal open. Firstly, at the left side of the uterus, a Vicryl number two (No..2) stitch will be inserted very close to the cervix from the anterior to the posterior side of the broad ligament.

Group A

Anterior wall uterine resection: PROCEDURE

After fetal delivery, two corners of the uterine incision and the superior and inferior lips will be clamped immediately by four Mayo clamps. Blunt dissection downward to the bladder-uterus peritoneal reflection will perform, to the partial anterior wall of the uterine myometrium where the placenta was deeply adherent (a myometrium defect, with only the serous layer of the uterus) will be respected, together with the placenta. It is important to ensure that sufficient myometrium above the peritoneal reflection will be available for an optimum closure. Then, as much remaining placenta as possible will be removed piecemeal from the edge of the uterine incision. Clamps and multiple hemostatic sutures will be applied rapidly

Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: pregnant females diagnosed to have placenta Previa or morbidly adherent placenta
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient with FIGO classification of PAS disorders Grade 1 \& Grade 2 which diagnosed by :
• Loss of normal hypoechoic retroplacental zone.
• Multiple vascular lacunae (irregular vascular spaces) within placenta, giving "Swiss cheese" appearance.
• Retroplacental myometrial thickness of less 1 mm. 2- Patient welling to preserve fertility.

You may not qualify if:

• Patient with FIGO classification of PAS disorders Grade 3 (interruption of the hyperechoic border between the uterine serosa and bladder by US).
• Age : \>40 years old. 3- Patient has medical disorders: cardiac disease, uncontrolled DM, chronic renal disease, chronic liver disease.
• Patient who refuse to participate in the study.

Sponsors & Collaborators

• Mansoura University Hospital: lead

Study Sites (1)

Faculty of Medicine

Al Mansurah, Dakahlia Governorate, 050, Egypt

Location

Related Publications (3)

• Jauniaux E, Ayres-de-Campos D, Langhoff-Roos J, Fox KA, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO classification for the clinical diagnosis of placenta accreta spectrum disorders. Int J Gynaecol Obstet. 2019 Jul;146(1):20-24. doi: 10.1002/ijgo.12761.

  PMID: 31173360 BACKGROUND

• Jauniaux E, Kingdom JC, Silver RM. A comparison of recent guidelines in the diagnosis and management of placenta accreta spectrum disorders. Best Pract Res Clin Obstet Gynaecol. 2021 Apr;72:102-116. doi: 10.1016/j.bpobgyn.2020.06.007. Epub 2020 Jun 27.

  PMID: 32698993 BACKGROUND

• Zhao X, Tao Y, Du Y, Zhao L, Liu C, Zhou Y, Wei P. The application of uterine wall local resection and reconstruction to preserve the uterus for the management of morbidly adherent placenta: Case series. Taiwan J Obstet Gynecol. 2018 Apr;57(2):276-282. doi: 10.1016/j.tjog.2018.02.017.

  PMID: 29673673 BACKGROUND

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: \- Randomized controlled trial (RCT) of pregnant women recruited from Department of Obstetrics and Gynecology Mansoura University Hospitals for elective termination of pregnancy

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 8, 2020
• Study Start: September 30, 2020
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)