Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion

IUCD Complication Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500015
• Other study ID #: aswu/354/4/19
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: September 2021
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: August 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• IUCD Complication

Intervention

Drug:
• INH
3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
• Placebo Comparator
3 tablet of placebo self-inserted by the patient 12 hours before IUD insertion.

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in pain scores during intrauterine device insertion	The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10	10 minutes
Secondary	duration of IUD insertion	duration of IUD insertion measured in minutes	10 minutes
Secondary	Provider ease of insertion	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.	10 minutes