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
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
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
NCT ID
NCT04579965
First Posted
September 28, 2020
Last Updated
October 4, 2020
Sponsor
Mansoura University Hospital
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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