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

Phase 4

Completed

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

• Registration Number: NCT04500028
• Lead Sponsor: Aswan University Hospital

Brief 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.

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 Start: 2020-08-01
• Study First Submitted: 2020-08-02
• Study First Submitted QC: 2020-08-02
• Study First Posted: 2020-08-05
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo Comparator	one tablet of placebo inserted by the study nurse 4 hours before IUD insertion.
INH	INH	3 vaginal tablet of isonicotinic acid hydrazide (900mg) ( inserted by the study nurse 4 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
duration of IUD insertion	10 minutes	duration of IUD insertion measured in minutes

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt