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Darwish Test in Women Using Minipills

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ClinicalTrials.gov Identifier: NCT04368104
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Professor Atef Darwish, Woman's Health University Hospital, Egypt

Brief Summary:
One of the mechanisms of action of progesterone-only contraceptive pills (minipills) is increased tubal peristalsis without any scientific documentation. We succeeded to document visualization of peristalsis of the proximal part of the Fallopian tubes and anatomic tubal patency as well (Darwish test) via hysteroscopy. This study will test status of proximal tubal peristalsis in women using minipills.

Condition or disease Intervention/treatment
Fallopian Tube Peristalsis and Patency Diagnostic Test: Darwish test (office hysteroscopic bubble suction and tubal peristalsis)

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Study Type : Observational
Estimated Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Darwish Test (Office Hysteroscopic Bubble Suction and Tubal Peristalsis) in Women Using Minipills
Estimated Study Start Date : May 29, 2020
Estimated Primary Completion Date : May 5, 2021
Estimated Study Completion Date : May 9, 2021

Group/Cohort Intervention/treatment
Group A
women using any form of minipills
Diagnostic Test: Darwish test (office hysteroscopic bubble suction and tubal peristalsis)
Testing Darwish test (office hysteroscopic bubble suction test and proximal tubal peristalsis) in women using minipills versus other cases not using hormones..

Group B
women subjected to office hysteroscopy for different indications but not using any form of hormones or systemic or local hormonal contraception.
Diagnostic Test: Darwish test (office hysteroscopic bubble suction and tubal peristalsis)
Testing Darwish test (office hysteroscopic bubble suction test and proximal tubal peristalsis) in women using minipills versus other cases not using hormones..




Primary Outcome Measures :
  1. office hysteroscopic bubble suction test and proximal tubal peristalsis in women using minipills versus non users of any hormones.. [ Time Frame: 1 month ]
    case control



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
women using any form of minipills (Desogestrel 75 µg, or Norethisterone 350 µg) asigned as group A and women subjected to office hysteroscopy for other indications (group B).
Criteria

Inclusion Criteria:

  • women using minipills.
  • women planned for office hysteroscopy for other indication.

Exclusion Criteria:

  • A suspected pregnancy.
  • heavy vaginal bleeding.
  • active pelvic inflammatory disease (PID).
  • severe co-morbidity, e.g., severe cardiac, neurologic, or chest disease
  • Other medical contraindications to pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368104


Locations
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Egypt
Woman's Health University Hospital Recruiting
Assiut, Egypt, 71111
Contact: Atef MM Darwish, MD PhD    0201001572723    atef_darwish@yahoo.com   
Woman's Health University Hospital Recruiting
Assiut, Egypt, 71111
Contact: Atef MM Darwisjh, MD PhD    0201001572723    atef_darwish@yahoo.com   
Sponsors and Collaborators
Woman's Health University Hospital, Egypt
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Responsible Party: Professor Atef Darwish, Professor of Obstetrics and Gynecology, Woman's Health University Hospital, Egypt
ClinicalTrials.gov Identifier: NCT04368104    
Other Study ID Numbers: Darwish test and minipills
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 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 Professor Atef Darwish, Woman's Health University Hospital, Egypt:
hysteroscopy
tubal patency
bubble suction test
tubal peristalsis
minipills