CompletedPhase 4

Vaginal Isonicotinic Acid Hydrazide Administration Prior to Insertion Levonorgestrel-releasing Intrauterine System

Egypt220 participantsStarted 2020-08-01

Plain-language summary

To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion Criteria: * Non-pregnant women * 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: * Women with any uterine abnormalities such as congenital anomalies, endometrial lesions, adenomyosis, or fibroids. * 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 * known psychiatric disorders ( anxiety and depression) and chronic use of medications that could interfere with pain perception (antidepressants and anticonvulsants) * Women refuse to participate in the study

What they're measuring

The difference in pain scores during intrauterine device insertion

Timeframe: 10 minutes

Trial details

NCT IDNCT04500028

SponsorAswan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-31

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