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OpenTrials
Completed

NCT Number: NCT04500015

Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion

To investigate whether vaginal isonicotinic acid hydrazide administered before the levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.

Completed

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Key information

Conditions

IUCD Complication

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Aswan University Hospital

Aswān, 81528, Egypt

About this study

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device

Exclusion criteria

  • pregnancy and
  • contraindication or allergy to or contraindication to IUD insertion,
  • chronic pelvic pain,
  • pelvic inflammatory disease,
  • analgesic intake 24 hours prior to IUD insertion.

Treatment and study plan

INH

Drug

3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.

placebo comparator

Drug

3 tablet of placebo self-inserted by the patient 12 hours before IUD insertion.

Primary outcomes

  1. The difference in pain scores during intrauterine device insertion

    Time frame: 10 minutes

    The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

Secondary outcomes

  1. duration of IUD insertion

    Time frame: 10 minutes

    duration of IUD insertion measured in minutes

  2. Provider ease of insertion

    Time frame: 10 minutes

    Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion.

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

Benefits of Self-administered Vaginal Isonicotinic Acid Hydrazide (INH) Administration 12 Hours Prior to Intrauterine Device Insertion in Adolescent and Young Women: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2020
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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