Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion

Phase 4

Completed

• Conditions: IUCD Complication
• Interventions: Drug: Placebo Comparator; Drug: INH

• Registration Number: NCT04500015
• Lead Sponsor: Aswan University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-08-02
• Study First Submitted QC: 2020-08-02
• Study First Posted: 2020-08-05
• Study Start: 2020-09-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo Comparator	3 tablet of placebo self-administered by the patient 12 hours before IUD insertion
INH	INH	3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Provider ease of insertion	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.
duration of IUD insertion	10 minutes	duration of IUD insertion measured in minutes

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt