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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dysfunctional Uterine Bleeding

Intervention / Treatment
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* Drug: medical treatment of isthmocele


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: combined contraceptive pills<br>treat patients with isthmocele with oral contraceptive pills | Drug: medical treatment of isthmocele<br>* comparison between different drugs<br>|
| Other: Misotac<br>treat patients with isthmocele with misotac. | Drug: medical treatment of isthmocele<br>* comparison between different drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postmenstrual spotting. | the effect of the drugs on the number of days with postmenstrual spotting during a menstrual cycle. | after one month of drug treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, Satisfaction assessed by the VAS | the effect of the drugs on Quality of life, Satisfaction | after one month of drug treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenstrual bleeding, Isthmocele, Combined Oral Contraceptive Pill, Misotac