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Misotac vs Combined Oral Contraceptive Pill in the Treatment of Symptomatic Isthmocele

Primary Purpose

Dysfunctional Uterine Bleeding

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
medical treatment of isthmocele
Sponsored by
Mansoura University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysfunctional Uterine Bleeding focused on measuring Postmenstrual bleeding, Isthmocele, Combined Oral Contraceptive Pill, Misotac

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women with a previous cesarean section
  • who presented with postmenstrual spotting,
  • sonohysterography had shown a isthmocele

Exclusion Criteria:

  • Pregnancy,
  • (suspected) malignancies,
  • use of any hormonal contraceptives,
  • fibroid,
  • infection in the genital tract

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    combined contraceptive pills

    Misotac

    Arm Description

    treat patients with isthmocele with oral contraceptive pills

    treat patients with isthmocele with misotac.

    Outcomes

    Primary Outcome Measures

    postmenstrual spotting.
    the effect of the drugs on the number of days with postmenstrual spotting during a menstrual cycle.

    Secondary Outcome Measures

    Quality of life, Satisfaction assessed by the VAS
    the effect of the drugs on Quality of life, Satisfaction

    Full Information

    First Posted
    September 28, 2020
    Last Updated
    October 4, 2020
    Sponsor
    Mansoura University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04579965
    Brief Title
    Misotac vs Combined Oral Contraceptive Pill in the Treatment of Symptomatic Isthmocele
    Official Title
    Misotac vs Combined Oral Contraceptive Pill in the Treatment of Symptomatic Isthmocele
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2020 (Anticipated)
    Primary Completion Date
    October 1, 2021 (Anticipated)
    Study Completion Date
    December 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

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

    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
    Isthmocele is a growing concern as a cause of abnormal uterine bleeding, especially post menstrual bleeding which may be present in up to 82% of these cases (Iannone et al 2019). our trial is a randomized clinical trial in which women will be randomly allocated to either medical treatment by oral contraceptive or to medical treatment by misotac.
    Detailed Description
    Isthmocele is a growing concern as a cause of abnormal uterine bleeding, especially post menstrual bleeding which may be present in up to 82% of these cases There is no universal standard definition of isthmocele but most of the authors agree that isthmocele as a myometrial discontinuity in the myometrium of the anterior uterine wall of >2mm at the site of a cesarean scar in non-pregnant women. Treatment should be offered only to the symptomatic patient. Surgery, by hysteroscopy, laparoscopy, laparotomy, or vaginal routes, is the most common treatment of choice even in the small defect Surgery is not without complications and many women reject it as a treatment option so it is reasonable to look for medical methods of management. The pathogenesis of AUB following the development of isthmocele remains unexplained. Oral contraceptive pills might represent a valid option due to a regulatory effect on the endometrium. Several authors describe the effectiveness of oral contraceptives in reducing bleeding disorders correlated to isthmocele. Another theory of AUB following the development of isthmocele is that menstrual blood can be collected in the defect so that it seeps slowly over the days following menstruation. This mechanism is added by impaired uterine contractility at the scar area. Misoprostol is a synthetic analog of prostaglandin E1, which increases myometrial contractions so it can be used for various other indications in obstetrics and gynecology the aim is to examine two different methods of medical treatment in cases of symptomatic isthmocele; first regulatory effect on the endometrium (Oral contraceptive pills) and second contraction of myometrium (misotac) Patient and methods: Women with a previous cesarean section who presented with postmenstrual spotting, and in whom sonohysterography had shown a isthmocele were eligible. A isthmocele was defined as an indentation in the anterior uterine wall at the site of the caesarean scar with at least 2 mm depth, measured during sonohysterography. Postmenstrual spotting needed to be present for at least three consecutive months after the last cesarean section. Postmenstrual spotting was defined as two or more days of brownish discharge at the end of menstrual bleeding when the total period of menstrual bleeding exceeds 7 days Exclusion criteria included any organic condition that will be the cause of that bleeding; Pregnancy, (suspected) malignancies, use of any hormonal contraceptives, fibroid, infection in the genital tract, etc. Randomization After written informed consent was given, women were randomly allocated to either medical treatment by oral contraceptive or to medical treatment by misotac.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysfunctional Uterine Bleeding
    Keywords
    Postmenstrual bleeding, Isthmocele, Combined Oral Contraceptive Pill, Misotac

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    combined contraceptive pills
    Arm Type
    Other
    Arm Description
    treat patients with isthmocele with oral contraceptive pills
    Arm Title
    Misotac
    Arm Type
    Other
    Arm Description
    treat patients with isthmocele with misotac.
    Intervention Type
    Drug
    Intervention Name(s)
    medical treatment of isthmocele
    Intervention Description
    comparison between different drugs
    Primary Outcome Measure Information:
    Title
    postmenstrual spotting.
    Description
    the effect of the drugs on the number of days with postmenstrual spotting during a menstrual cycle.
    Time Frame
    after one month of drug treatment
    Secondary Outcome Measure Information:
    Title
    Quality of life, Satisfaction assessed by the VAS
    Description
    the effect of the drugs on Quality of life, Satisfaction
    Time Frame
    after one month of drug treatment

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women with a previous cesarean section who presented with postmenstrual spotting, sonohysterography had shown a isthmocele Exclusion Criteria: Pregnancy, (suspected) malignancies, use of any hormonal contraceptives, fibroid, infection in the genital tract

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30646424
    Citation
    Iannone P, Nencini G, Bonaccorsi G, Martinello R, Pontrelli G, Scioscia M, Nappi L, Greco P, Scutiero G. Isthmocele: From Risk Factors to Management. Rev Bras Ginecol Obstet. 2019 Jan;41(1):44-52. doi: 10.1055/s-0038-1676109. Epub 2019 Jan 15.
    Results Reference
    background
    PubMed Identifier
    31166450
    Citation
    Kremer TG, Ghiorzi IB, Dibi RP. Isthmocele: an overview of diagnosis and treatment. Rev Assoc Med Bras (1992). 2019 Jun 3;65(5):714-721. doi: 10.1590/1806-9282.65.5.714.
    Results Reference
    background
    PubMed Identifier
    27473332
    Citation
    Zhang X, Yang M, Wang Q, Chen J, Ding J, Hua K. Prospective evaluation of five methods used to treat cesarean scar defects. Int J Gynaecol Obstet. 2016 Sep;134(3):336-9. doi: 10.1016/j.ijgo.2016.04.011. Epub 2016 Jun 30.
    Results Reference
    background
    PubMed Identifier
    21204608
    Citation
    Florio P, Gubbini G, Marra E, Dores D, Nascetti D, Bruni L, Battista R, Moncini I, Filippeschi M, Petraglia F. A retrospective case-control study comparing hysteroscopic resection versus hormonal modulation in treating menstrual disorders due to isthmocele. Gynecol Endocrinol. 2011 Jun;27(6):434-8. doi: 10.3109/09513590.2010.495431. Epub 2011 Jan 4.
    Results Reference
    background
    PubMed Identifier
    16769058
    Citation
    Tahara M, Shimizu T, Shimoura H. Preliminary report of treatment with oral contraceptive pills for intermenstrual vaginal bleeding secondary to a cesarean section scar. Fertil Steril. 2006 Aug;86(2):477-9. doi: 10.1016/j.fertnstert.2006.01.020. Epub 2006 Jun 12.
    Results Reference
    background
    PubMed Identifier
    9952074
    Citation
    Thurmond AS, Harvey WJ, Smith SA. Cesarean section scar as a cause of abnormal vaginal bleeding: diagnosis by sonohysterography. J Ultrasound Med. 1999 Jan;18(1):13-6; quiz 17-8. doi: 10.7863/jum.1999.18.1.13.
    Results Reference
    background
    PubMed Identifier
    28490770
    Citation
    Wu HL, Marwah S, Wang P, Wang QM, Chen XW. Misoprostol for medical treatment of missed abortion: a systematic review and network meta-analysis. Sci Rep. 2017 May 10;7(1):1664. doi: 10.1038/s41598-017-01892-0.
    Results Reference
    background
    PubMed Identifier
    23680518
    Citation
    Tower AM, Frishman GN. Cesarean scar defects: an underrecognized cause of abnormal uterine bleeding and other gynecologic complications. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):562-72. doi: 10.1016/j.jmig.2013.03.008. Epub 2013 May 14.
    Results Reference
    background
    PubMed Identifier
    28504857
    Citation
    Vervoort A, van der Voet LF, Hehenkamp W, Thurkow AL, van Kesteren P, Quartero H, Kuchenbecker W, Bongers M, Geomini P, de Vleeschouwer L, van Hooff M, van Vliet H, Veersema S, Renes WB, Oude Rengerink K, Zwolsman SE, Brolmann H, Mol B, Huirne J. Hysteroscopic resection of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial. BJOG. 2018 Feb;125(3):326-334. doi: 10.1111/1471-0528.14733. Epub 2017 Jul 5.
    Results Reference
    background

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    Misotac vs Combined Oral Contraceptive Pill in the Treatment of Symptomatic Isthmocele

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