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

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ClinicalTrials.gov Identifier: NCT04579965
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Alaa Wageh, Mansoura University Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Dysfunctional Uterine Bleeding Drug: medical treatment of isthmocele Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Misotac vs Combined Oral Contraceptive Pill in the Treatment of Symptomatic Isthmocele
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : December 1, 2021
Arms and Interventions
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Arm Intervention/treatment
combined contraceptive pills
treat patients with isthmocele with oral contraceptive pills
 Drug: medical treatment of isthmocele
comparison between different drugs
Misotac
treat patients with isthmocele with misotac.
 Drug: medical treatment of isthmocele
comparison between different drugs


Outcome Measures
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Primary Outcome Measures :
  1. postmenstrual spotting. [ Time Frame: after one month of drug treatment ]
    the effect of the drugs on the number of days with postmenstrual spotting during a menstrual cycle.


Secondary Outcome Measures :
  1. Quality of life, Satisfaction assessed by the VAS [ Time Frame: after one month of drug treatment ]
    the effect of the drugs on Quality of life, Satisfaction


Eligibility Criteria
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Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: Alaa Wageh, Alaa Wageh Associate Professor Obstetrics and gynecology, Mansoura University Hospital
ClinicalTrials.gov Identifier: NCT04579965    
Other Study ID Numbers: 1
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alaa Wageh, Mansoura University Hospital:
Postmenstrual bleeding
Isthmocele
Combined Oral Contraceptive Pill
Misotac
Additional relevant MeSH terms:
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Uterine Hemorrhage
Metrorrhagia
Hemorrhage
Pathologic Processes
Uterine Diseases