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

NCT04579965 | Unknown

• 1 other identifier: 1
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dysfunctional Uterine Bleeding

Keywords

Postmenstrual bleeding; Isthmocele; Combined Oral Contraceptive Pill; Misotac

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life, Satisfaction assessed by the VAS

  after one month of drug treatment

Study Arms (2)

combined contraceptive pills

OTHER

treat patients with isthmocele with oral contraceptive pills

Drug: medical treatment of isthmocele

Misotac

OTHER

treat patients with isthmocele with misotac.

Drug: medical treatment of isthmocele

Interventions

medical treatment of isthmocele DRUG

comparison between different drugs

Misotac; combined contraceptive pills

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University Hospital: lead

Related Publications (9)

• 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.

  PMID: 30646424 BACKGROUND

• 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.

  PMID: 31166450 BACKGROUND

• 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.

  PMID: 27473332 BACKGROUND

• 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.

  PMID: 21204608 BACKGROUND

• 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.

  PMID: 16769058 BACKGROUND

• 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.

  PMID: 9952074 BACKGROUND

• 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.

  PMID: 28490770 BACKGROUND

• 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.

  PMID: 23680518 BACKGROUND

• 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.

  PMID: 28504857 BACKGROUND

MeSH Terms

Conditions

Metrorrhagia

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alaa Wageh Associate Professor Obstetrics and gynecology

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 8, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share