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

Z

Zagazig University

Status

Not yet enrolling

Conditions

Cervical IO Plasty in Management of Placenta Previa

Treatments

Combination Product: cervical internal os plasty

Study type

Interventional

Funder types

Other

Identifiers

NCT05560984
Cervix IO in placenta previa

Details and patient eligibility

About

Aim of the work:

Better management & reducing hemorrhage and complication in patients placenta previa and focal accreta .

Full 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.

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

study population
Experimental group
Description:
Women with previous one or more cesarean sections with placenta previa and focal accrete
Treatment:
Combination Product: cervical internal os plasty

Trial contacts and locations

0

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Central trial contact

Al Shymaa Mohamed; Basem Hamed

Data sourced from clinicaltrials.gov

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