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Cervical Internal os Plasty in Management of Placenta Previa and Focal Accreta

Cervical Internal os Plasty in Management of Placenta Previa and Focal Accreta

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05560984
Enrollment
40
Registered
2022-09-30
Start date
2022-10-31
Completion date
2023-02-28
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical IO Plasty in Management of Placenta Previa

Brief summary

Aim of the work: Better management & reducing hemorrhage and complication in patients placenta previa and focal accreta .

Detailed description

Placenta accrete spectrum (PAS) is one of the major causes of massive obstetric hemorrhage and life-threatening complication of pregnancy. Patients with placenta previa may develop severe postpartum hemorrhage especially when coinciding with placenta accreta, it may be associated with potentially life-threatening maternal hemorrhage after removal of the placenta due to its incomplete separation and massive bleeding from the placental attachment site. Normally, the placenta adheres only to the decidua basalis, thus it separates smoothly from the wall of the uterus after delivery. Placenta accreta (PA) exists when the chorionic villi penetrate through the decidua basalis into the myometrium . The steady rise of cesarean section (CS) delivery rates in recent years combined with increasing maternal age, multiparity, placenta previa, prior uterine surgeries or curettage, and Asherman syndrome is associated with increasing incidence of PAS. In a systematic review, the rate of placenta accreta spectrum (PAS) increase from 0.3% in women with one previous cesarean delivery to 6.74% for women with five or more cesarean deliveries . In the setting of a placenta previa and one or more previous cesarean deliveries, the risk of PAS dramatically increases. For women with placenta previa, the risk of placenta accrete is 3%, 11%, 40%, 61%, 67%, for the first, second, third, fourth, and fifth or more cesareans, respectively. Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. The maternal mortality in women with PA may reach as high as 7-10 % . Acute torrential bleeding, massive blood transfusion, hysterectomy, and even the death of the woman can occur during cesarean delivery because of placenta previa increta. As intraoperative bleeding from PASin the lower uterine segment is often vast, massive, dramatically quick and difficult to stop after removal of the placenta resulting in severe maternal morbidity and mortality it is of outmost importance to have a pre-planned approach to this surgical challenge that is effective and swift. The differences between the lower and upper segments of the uterus are the main cause for postpartum hemorrhage associated with placenta accreta spectrum. The lower uterine segment is highly vascular and slower to retract than upper segment. Surgical intervention is indicated when uterotonic medications fail to control blood loss . The optimal management of PAS remains controversial. However, in practice, the conservative methods sometimes are incapable of stopping the bleeding from the placental attachment site. Moreover, the success of some surgical techniques, such as blood vessel ligation, has been associated with the experience and proficiency of the obstetricians, and in many hospitals, the conditions do not exist for performing perioperative temporary balloon occlusion of the internal iliac arteries and uterine arterial embolization. If these procedures prove invalid, hysterectomy is performed to ensure maternal survival. Currentseveral clinical hemostatic techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections, including uterine packing with gauze , balloon tamponades,superposition sutures,hemostatic multiple square suturing, insertion of parallel vertical compression sutures , and so on when the bleeding is not so severe. If necessary, obstetricians often attempt to employ B-Lynch sutures, and embolization or ligation of the uterine and internal iliac arteries ,but there is a wide variation in the success rate of these maneuvers . There is lack of consensus on the optimal uterine sparing surgical approach to reduce intraoperative bleeding if the placenta is partially separated. Whilst electing for timely hysterectomy may be recommended and lifesaving, this may not be ideal for women wishing to preserve their fertility and uterine sparing alternative interventions are highly needed.

Interventions

COMBINATION_PRODUCTcervical internal os plasty

A long Allis forceps will be passed through the uterine incision and used to grasp the anterior lip of the cervix, pulling the cervix upwards into the uterine cavity. An assistant sometimes needs to elevate the cervix upwards from the vaginal aspect. The anterior lip of the cervix will be sutured to the anterior wall of the lower uterine segment using two or three simple interrupted absorbable stitches (Vicryl or Vicryl rapid no. 0). This aids to compress the bleeding sites of the placental bed and support the very thin lower uterine segment. If the placenta was implanted posteriorly and the bleeding areas will be mainly from the posterior wall of the uterus, the same procedure could be repeated using the posterior lip of the cervix. A Hegar dilator (size 12) will be inserted in a retrograde manner from the abdominal aspect toensure patency of the cervical canal .

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* All the participants with placent aprevia and focal accreta will be diagnosed by ultrasound and color Doppler. * One or more previous cesarean section. * Gestational age of 32 - 38 weeks. * Desire to preserve the uterus

Exclusion criteria

* Diffuse placenta accreta. * Placenta percreta. * Presence of uncontrollable hemorrhage

Design outcomes

Primary

MeasureTime frame
amount of intra-operative blood loss (mL)5 months

Secondary

MeasureTime frame
Number of patients need blood transfusion5 months
Number of patients need hysterectomy5 months
Number of patients develop postpartum hemorrhage (500 mL or greater).5 months
Time needed to perform the technique (minutes).5 months
Number ot participants develop complications: •Urinary bladder injury •Wound infection •Postoperative fever.5 months
Mean duration of postoperative hospital stay (days).5 months

Contacts

Primary ContactAl Shymaa Mohamed
obgyns90@gmail.com01098721121
Backup ContactBasem Hamed
01004132040

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026