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Cesarean Section Defect Mechanism and Transvaginal Repair

Primary Purpose

Cesarean Scar Defect; Transvaginal Diverticulum Resection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Suture method
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Scar Defect; Transvaginal Diverticulum Resection

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years, premenopausal female; The scar is the transverse incision of the lower segment of the uterus (one or more times); The following abnormal uterine bleeding occurred after cesarean section: prolonged menstruation/endless menstruation ≥ 14 days, menstrual bleeding; Transvaginal three-dimensional ultrasound/pelvic MRI plain scan showed that the thickness of residual muscular layer at the top of diverticulum was less than 3 mm; The effect of drug treatment is poor, and it is difficult to adhere to long-term drug treatment or surgical treatment; HGB > 100g/L before operation; Hysteroscopy excluded endometrial lesions; The patient or family members can understand the study protocol and voluntarily participate in the study, and provide written informed consent. Exclusion Criteria: The data of cesarean section is not complete, and the previous cesarean section method cannot be determined; Abnormal uterine bleeding caused by endocrine disorders (thyroid dysfunction, luteal insufficiency), endometrial lesions, uterine fibroids, gynecological tumors, blood system diseases, pelvic infections, intrauterine devices, etc; Infertility patients caused by female oviduct infertility, intrauterine adhesion infertility, uterine malformation, polycystic ovary syndrome, male infertility, etc; Patients with other serious gynecological diseases and/or serious physical or psychological diseases; Pregnancy (women of childbearing age were positive in pregnancy test at baseline or did not receive pregnancy test), and women in lactation; Patients who are unable to complete the follow-up; The patient or family members could not understand the conditions and objectives of the study and did not agree to participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    One-layered Suture

    Two-layered Suture

    Arm Description

    One-layered Suture in transvaginal diverticulum resection

    Two-layered Suture in transvaginal diverticulum resection

    Outcomes

    Primary Outcome Measures

    Prolongation of menstrual period
    Patients' subject description of the duration of menstrual period, which is defined as the first day of menstruation to the end day

    Secondary Outcome Measures

    fertility outcome
    record the post-operative fertility outcome, including natural pregnancy or assisted reproduction, and the correspondence fertility outcome, such as premature birth, premature rupture of membranes, etc.

    Full Information

    First Posted
    November 29, 2022
    Last Updated
    December 6, 2022
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05643703
    Brief Title
    Cesarean Section Defect Mechanism and Transvaginal Repair
    Official Title
    A Prospective Randomized Controlled Study on the Efficacy and Safety of Different Suture Methods for the Transvaginal Repair of Cesarean Section Defect and the Exploration of the Underlying Molecular Mechanism of the Defect Occurrence
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 20, 2022 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    November 20, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Background and aims: Cesarean section defect (CSD) can cause abnormal uterine bleeding or impaired fertility, which severely impaire the quality of life in women of pregnant age. For women with moderate or severe CSD, surgery can be performed. The objectives of this study is to compare the efficacy and safety of different suture methods in the treatment of transvaginal diverticulum resection, and the underlying mechanism of CSD occurrence. Methods: The patients diagnosed with CSD will be enrolled and randomizely assigned into suture method A and suture method. The fresh isolated tissue and swab of different sites in genital tract will be collected for NGS, microbiome, metabonomics and proteomics analysis. Hypothesis: The menstruation will be analyzed at different following time. The other clinical information will be also collected, including age at surgery, skin-to skin operative time, estimated blood loss (EBL). The perioperative complications, postoperative hopitalization, cost for hospital stay, blasser/intestinal function recovery will also be compared between two gorup. The outcome of fertility will be compared, such as the premature birth, premature rupture of membranes, and rupture of uterus. The clinical manifestation related to CSD and recurrence will be followed. Besides, the underlying mechanism will be analyzed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cesarean Scar Defect; Transvaginal Diverticulum Resection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    One-layered Suture
    Arm Type
    Experimental
    Arm Description
    One-layered Suture in transvaginal diverticulum resection
    Arm Title
    Two-layered Suture
    Arm Type
    Experimental
    Arm Description
    Two-layered Suture in transvaginal diverticulum resection
    Intervention Type
    Procedure
    Intervention Name(s)
    Suture method
    Intervention Description
    One-layered Suture: Single layer intermittent suture; Two-layered Suture:Single layer intermittent suture plus U type reinforcement stitching
    Primary Outcome Measure Information:
    Title
    Prolongation of menstrual period
    Description
    Patients' subject description of the duration of menstrual period, which is defined as the first day of menstruation to the end day
    Time Frame
    3 month after surgery
    Secondary Outcome Measure Information:
    Title
    fertility outcome
    Description
    record the post-operative fertility outcome, including natural pregnancy or assisted reproduction, and the correspondence fertility outcome, such as premature birth, premature rupture of membranes, etc.
    Time Frame
    within 5 years after surgery
    Other Pre-specified Outcome Measures:
    Title
    objective measurement of caesarean scar diverticulum
    Description
    The difference of different diameters of caesarean scar diverticulum before and after surgery
    Time Frame
    within 1 years after surgery

    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: Age ≥ 18 years, premenopausal female; The scar is the transverse incision of the lower segment of the uterus (one or more times); The following abnormal uterine bleeding occurred after cesarean section: prolonged menstruation/endless menstruation ≥ 14 days, menstrual bleeding; Transvaginal three-dimensional ultrasound/pelvic MRI plain scan showed that the thickness of residual muscular layer at the top of diverticulum was less than 3 mm; The effect of drug treatment is poor, and it is difficult to adhere to long-term drug treatment or surgical treatment; HGB > 100g/L before operation; Hysteroscopy excluded endometrial lesions; The patient or family members can understand the study protocol and voluntarily participate in the study, and provide written informed consent. Exclusion Criteria: The data of cesarean section is not complete, and the previous cesarean section method cannot be determined; Abnormal uterine bleeding caused by endocrine disorders (thyroid dysfunction, luteal insufficiency), endometrial lesions, uterine fibroids, gynecological tumors, blood system diseases, pelvic infections, intrauterine devices, etc; Infertility patients caused by female oviduct infertility, intrauterine adhesion infertility, uterine malformation, polycystic ovary syndrome, male infertility, etc; Patients with other serious gynecological diseases and/or serious physical or psychological diseases; Pregnancy (women of childbearing age were positive in pregnancy test at baseline or did not receive pregnancy test), and women in lactation; Patients who are unable to complete the follow-up; The patient or family members could not understand the conditions and objectives of the study and did not agree to participate in the study.

    12. IPD Sharing Statement

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    Cesarean Section Defect Mechanism and Transvaginal Repair

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