Clinical trial NCT04660578: A.Chohan Continuous Squeezing Suture (ACCSS) for Placenta Previa / Accreta
Official title: A.Chohan Continuous Squeezing Suture (ACCSS) for Controlling Hemorrhage From the Lower Uterine Segment at the Cesarean Section for Placenta Previa / Accreta: a Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Previa With Hemorrhage - Delivered
Placenta Accreta
Keywords: Postpartum hemorrhage
Peripartum hysterectomy
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group
Primary purpose: TREATMENT

Brief summary: Placenta praevia and accreta spectrum disorders are rising in incidence due to increased rate of repeat caesarean sections. Peripartum hysterectomy remains the only definitive treatment of massive postpartum haemorrhage related to this condition. A multitude of conservative treatments is described in literature, which includes pelvic devascularization under radiological control, myometrial resection with placenta in situ, and various suturing techniques some involving inversion of cervix. Variable success rates are described, but search continues for a simple, safe and effective treatment. Such a surgical technique i.e. A. Chohan Continuous Squeezing Suture (ACCSS) is described in this study for controlling haemorrhage from the lower uterine segment at caesarean section for placenta praevia and accrete spectrum disorders.

Detailed description: Postpartum haemorrhage (PPH) has always been a prominent cause of maternal morbidity as well as mortality worldwide, with uterine atony as the leading cause and peripartum hysterectomy as the only definitive treatment option . Researchers are struggling throughout the years to find a treatment modality other than hysterectomy, which has least morbidity and potential to preserve fertility. In an attempt to find a non-radical treatment for PPH due to uterine atony, a novel uterine compression suture was introduced in 1997. The time then witnessed emergence of a series of its variants from all over the world which effectively lowered the incidence of peripartum hysterectomy from uterine atony.

Meanwhile the incidence of placenta praevia and placenta accreta spectrum disorder rose dramatically across the globe because of rising incidence of repeat caesarean sections. Placenta accreta spectrum has opened up a new era in the history of PPH, as forcible separation of adherent placenta leads to massive bleeding from placental bed. Peripartum hysterectomy has once again emerged as gold standard treatment for this variety of PPH with its overall morbidity of 40-50%, and mortality of 7-10% in case of placenta percreta. The fear of placental bed bleeding has led to the development of conservative managements like "leaving the placenta in situ approach" with its wide range of mild to severe, and serious morbidities. The conservative surgical techniques i.e. The triple P procedure, one step conservative surgery approach, have also used the concept of non-separation of placenta and have instead adopted resection of myometrium with placenta in situ. These surgeries involve devascularisation of deep pelvic / major abdominal vessels and ligation of complex arterial anastomosis making the procedure technically difficult. Moreover, the devascularisation is done under extensive and expensive interventional radiological equipment which places the procedures out of reach for the routine setups particularly in the under developed countries. Another conservative surgical technique i.e. stepwise surgical approach, which described separation of placenta also mainly relied upon devascularisation of pelvic organs by bilateral ligation of anterior branch of internal iliac artery rather than elaborating the details of technique of controlling haemorrhage at the actual bleeding site.

Three corners stones of uterine compression sutures have been described in literature i.e. simplicity, safety and efficacy and no such suturing technique so far is published. Hence, it's the time for innovation in the treatment of placenta praevia and PAS. In this study, we report our own experience of a conservative surgical technique i.e. A. Chohan Continuous Squeezing Suture (ACCSS) application in the lower uterine segment during caesarean section in profusely bleeding patients with placenta praevia and placenta accreta spectrum without involvement of urinary bladder and other pelvic organs. This surgical technique takes on the separation of placenta and describes a placental bed suturing without involvement of interventional radiology as well as ligation of deep pelvic vessels. The objective of this study is to assess the simplicity, safety and efficacy of this surgical technique in the management of PAS, with the intension to develop a simple, safe and effective alternative to hysterectomy.

Surgical Procedure:

After opening the abdomen, a transverse incision was given in the lower uterine segment after ascertaining the site of easy fetal access avoiding the placenta as far as possible. After the delivery of the baby, the uterus was exteriorized and routine uterotonics were given. The placenta was left in-situ and incision margins were held with Green-armitage forceps to minimize bleeding.

The urinary bladder was dissected away to allow suturing on the inner side of the lower uterine segment. Uterine arteries were ligated on both sides and any blood vessels on the way were secured immediately. The placenta was then removed completely.

Within the puddle of blood, the ring of internal os was identified with the index and middle finger of one hand and held with Babcock forceps with the other hand. On the exposed inner surface of the LUS, suturing was started from the left corner of uterine incision, taking multiple half cm bites through half-thickness of the tissue at half cm intervals to reach the outer half of ring of the internal os. The suture was then tied and knot secured causing squeezing of uterine tissue. From here onwards similar sutures were placed continuously at 1 cm distance till the right corner was reached, where the knot was secured. During suturing it was ensured that internal os remains patent. The continued pull on the suture caused the squeezing of the LUS and arrested bleeding from all sinuses present at the placental site. If the bleeding was seen on the posterior uterine wall, a similar suture was applied. It was started from the outer half of the posterior lip of the ring of the internal os and going up to the highest bleeding point on the posterior wall of the uterus, extending from the left to right end of the uterine incision.

Any left over bleeding points were secured with separate hemostatic sutures, Routine closure of the uterus was performed in two layers as in the lower segment cesarean section.

The hospital stay of the patients was 3-7 days. All patients were reviewed on 7th postoperative day and were inquired about the history of fever, abdominal pain and excessive vaginal bleeding. The character of vaginal discharge / lochia was noted and any urinary complaint recorded. Caesarean section wound was examined and stitches removed. Second follow up visit was at 6 weeks postpartum for similar assessment and record of lactation / menstruation status. Pelvic ultrasound was done on both visits to detect any pelvic organ abnormality and collection of blood or pus.

Eligibility criteria: Inclusion Criteria:

1. All consenting patients at 32 weeks of gestation, with the diagnosis of placenta previa and placenta accreta spectrum without involvement of bladder and other pelvic organs.
2. Woman who wished to conserve the uterus.

Exclusion Criteria:

1. Patients were excluded from the study if an emergency cesarean section was done due to severe antepartum hemorrhage before the plan of surgery.
2. Patients with Placenta accreta spectrum with bladder and/or other pelvic organ involvement.

Primary outcomes:
measure: Peripartum hysterectomy
timeFrame: 24 hours
Secondary outcomes:
measure: Application time of suture in minutes
timeFrame: within 20 minutes
measure: Estimated blood loss
timeFrame: duration of surgery in minutes
measure: Number of units of blood transfusions
timeFrame: First 24 hours
measure: Duration of stay of the participants in hospital in days
timeFrame: 7 days
measure: Number of patients requiring other conservative medical and surgical treatments
timeFrame: Duration of surgery in minutes
measure: Number of patients with urinary bladder trauma and its complication
timeFrame: 6 weeks
measure: Number of patients with secondary postpartum hemorrhage
timeFrame: 6 weeks
measure: Prevalence of maternal mortality
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University
state: Punjab
Study officials:
affiliation: King Edward Medical University, Lahore, Pakistan
name: Muhammad A Chohan, FRCOG, FCPS
role: PRINCIPAL_INVESTIGATOR
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