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

Primary Purpose

Cervical IO Plasty in Management of Placenta Previa

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cervical internal os plasty
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical IO Plasty in Management of Placenta Previa

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    study population

    Arm Description

    Women with previous one or more cesarean sections with placenta previa and focal accrete

    Outcomes

    Primary Outcome Measures

    amount of intra-operative blood loss (mL)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 24, 2022
    Last Updated
    October 5, 2022
    Sponsor
    Zagazig University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05560984
    Brief Title
    Cervical Internal os Plasty in Management of Placenta Previa and Focal Accreta
    Official Title
    Cervical Internal os Plasty in Management of Placenta Previa and Focal Accreta
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    January 2023 (Anticipated)
    Study Completion Date
    February 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Zagazig University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical IO Plasty in Management of Placenta Previa

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study population
    Arm Type
    Experimental
    Arm Description
    Women with previous one or more cesarean sections with placenta previa and focal accrete
    Intervention Type
    Combination Product
    Intervention Name(s)
    cervical internal os plasty
    Intervention Description
    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 .
    Primary Outcome Measure Information:
    Title
    amount of intra-operative blood loss (mL)
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    Number of patients develop postpartum hemorrhage (500 mL or greater).
    Time Frame
    5 months
    Title
    Number of patients need blood transfusion
    Time Frame
    5 months
    Title
    Number of patients need hysterectomy
    Time Frame
    5 months
    Title
    Mean duration of postoperative hospital stay (days).
    Time Frame
    5 months
    Title
    Time needed to perform the technique (minutes).
    Time Frame
    5 months
    Title
    Number ot participants develop complications: •Urinary bladder injury •Wound infection •Postoperative fever.
    Time Frame
    5 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Al Shymaa Mohamed
    Phone
    01098721121
    Email
    obgyns90@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Basem Hamed
    Phone
    01004132040

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29405321
    Citation
    Jauniaux E, Chantraine F, Silver RM, Langhoff-Roos J; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Epidemiology. Int J Gynaecol Obstet. 2018 Mar;140(3):265-273. doi: 10.1002/ijgo.12407. No abstract available.
    Results Reference
    background
    PubMed Identifier
    35036541
    Citation
    Kondoh E. Expectant Management of Placenta Accreta Spectrum Disorders. Surg J (N Y). 2021 Jun 3;7(Suppl 1):S2-S6. doi: 10.1055/s-0040-1722240. eCollection 2021 Dec.
    Results Reference
    background

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

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