Dysfunctional Uterine BleedingNCT04579965
Misotac vs Combined Oral Contraceptive Pill in the Treatment of Symptomatic Isthmocele
A study testing medical treatment of isthmocele in people with Dysfunctional Uterine Bleeding, run by Mansoura University Hospital.
Trial 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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Dysfunctional Uterine Bleeding
- What is being tested?
- medical treatment of isthmocele
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with a previous cesarean section
- who presented with postmenstrual spotting,
- sonohysterography had shown a isthmocele
Who cannot join
- Pregnancy,
- (suspected) malignancies,
- use of any hormonal contraceptives,
- fibroid,
- infection in the genital tract
About this study
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.
Read the 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.
- Conditions
- Dysfunctional Uterine Bleeding
- Being tested
- medical treatment of isthmocele
- Keywords
- Postmenstrual bleeding, Isthmocele, Combined Oral Contraceptive Pill, Misotac
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical treatment of isthmoceleDrug
comparison between different drugs
| Study group | Role | What they receive |
|---|---|---|
| combined contraceptive pills | Other | treat patients with isthmocele with oral contraceptive pills Receives: Drug: medical treatment of isthmocele |
| Misotac | Other | treat patients with isthmocele with misotac. Receives: Drug: medical treatment of isthmocele |
What is being measured
The primary outcome is the main question the study is designed to answer.
postmenstrual spotting.
the effect of the drugs on the number of days with postmenstrual spotting during a menstrual cycle.
Measured: after one month of drug treatment
Secondary outcomes (1)
Quality of life, Satisfaction assessed by the VAS
the effect of the drugs on Quality of life, Satisfaction
Measured: after one month of drug treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dysfunctional Uterine BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Wageh, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579965
- Sponsor's protocol ID
- 1
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30646424Kremer 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.
PubMed 31166450Zhang 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.
PubMed 27473332Florio 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.
PubMed 21204608Tahara 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.
PubMed 16769058Thurmond 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.
PubMed 9952074Wu 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.
PubMed 28490770Tower 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.
PubMed 23680518Vervoort 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.
PubMed 28504857
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misotac vs Combined Oral Contraceptive Pill in the Treatment of Symptomatic Isthmocele
- ClinicalTrials.gov ID
- NCT04579965
- Acronym / sponsor ID
- 1
- Conditions
- Dysfunctional Uterine Bleeding
- Keywords
- Postmenstrual bleeding, Isthmocele, Combined Oral Contraceptive Pill, Misotac
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined contraceptive pills | Other | Drug: medical treatment of isthmoceletreat patients with isthmocele with oral contraceptive pills |
| Misotac | Other | Drug: medical treatment of isthmoceletreat patients with isthmocele with misotac. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women with a previous cesarean section
- who presented with postmenstrual spotting,
- sonohysterography had shown a isthmocele
Key exclusion criteria (5 listed)
- Pregnancy,
- (suspected) malignancies,
- use of any hormonal contraceptives,
- fibroid,
- infection in the genital tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| medical treatment of isthmocelecomparison between different drugs | Drug | Misotac, combined contraceptive pills |
Primary outcome
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.
1 secondary outcome
Quality of life, Satisfaction assessed by the VAS
Time frame: after one month of drug treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 30646424Iannone 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.
- Background: PubMed 31166450Kremer 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.
- Background: PubMed 27473332Zhang 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.
- Background: PubMed 21204608Florio 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.
- Background: PubMed 16769058Tahara 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.
- Background: PubMed 9952074Thurmond 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.
- Background: PubMed 28490770Wu 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.
- Background: PubMed 23680518Tower 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.
- Background: PubMed 28504857Vervoort 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing medical treatment of isthmocele in people with Dysfunctional Uterine Bleeding, run by Mansoura University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postmenstrual spotting. (time frame: after one month of drug treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579965, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.