Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A Intrauterine Device Insertion
NCT ID: NCT04499989
Last Updated: 2021-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
220 participants
INTERVENTIONAL
2020-09-01
2021-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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INH
3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
INH
3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.
Placebo Comparator
3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion.
Placebo Comparator
3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion
Interventions
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INH
3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.
Placebo Comparator
3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women that did not receive any analgesics or Dinoprostone in the 24 hours prior to insertion
* Women who delivered only by cesarean section
Exclusion Criteria
* Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
* Allergy to isonicotinic acid hydrazide .
* Women refuse to participate in the study
18 Years
45 Years
FEMALE
No
Sponsors
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Aswan University Hospital
OTHER
Responsible Party
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hany farouk
A Professor
Principal Investigators
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nahla w Shady, md
Role: STUDY_CHAIR
Aswan universirty
Locations
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Aswan University Hospital
Aswān, , Egypt
Countries
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Other Identifiers
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aswu/353/4/19
Identifier Type: -
Identifier Source: org_study_id
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