Faculty of Medicine
Al Mansurah, Dakahlia Governorate, 050, Egypt
NCT Number: NCT04579172
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
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, 050, Egypt
Study Design & Area:
Randomized controlled trial (RCT) of pregnant women recruited from Department of Obstetrics and Gynecology Mansoura University Hospitals during September 2020 until September 2021 and may be extended if needed.
The study groups will undergo:
Informed consent
History:
Personal: (age, duration of marriage, special habits). Menstrual history Obstetric: (parity, mode of delivery, fetal outcome). Present history of any medical or obstetric problems. Past medical and surgical history. Clinical examination : General and obstetric examination
Calculation of Gestational Age :
Gestational age will be calculated by adding 280 days (40weeks) to the first day of the last menstrual period or by ultrasound.
Investigation:
Lab investigation:- Complete blood count , Bleeding profile, international normalization ratio, liver function tests, kidney function tests
Ultrasound:
Ultrasound Finding:- i. Establish the presence of a living fetus. ii. Estimate the age of the pregnancy. iii. Diagnose congenital abnormalities of the fetus. iv. Evaluate the position of the fetus. v. Determine the amount of amniotic fluid around the baby. vi. Assess fetal growth. vii. Assess fetal well-being. viii. Evaluate the position of the placenta.
Surgical Procedure:
Preparation of the patient before surgery:
After spinal anesthesia and skin sterilization Abdominal Incision: Pfannenstiel incision then cut the subcutaneous fat and rectus sheath and blunt entry into the peritoneal cavity .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2- Age : >40 years old. 3- Patient has medical disorders: cardiac disease, uncontrolled DM, chronic renal disease, chronic liver disease.
4- Patient who refuse to participate in the study.
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.
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
Time frame: from the start of uterine incision till closure of uterine wall
Time frame: from the induction of anesthesia till 2 hours after the end of surgery
Compare hemoglobin and hematocrit values before and after operation.
Time frame: from the start of induction of anesthesia till 24 hours after the end of surgery
Mansoura University Hospital
Other
Cervico-Isthmic Compression Suture Versus Anterior Wall Uterine Resection in Cases of Morbidly Adherent Anterior Situated Placenta
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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