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

IUCD Complication Clinical Trial

Official title:

Clinical Outcomes of Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to Levonorgestrel Releasing Intrauterine System Insertion in Women Delivered Only by Elective Cesarean Section: a Randomized Double Blinded Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500028
• Other study ID #: aswu/355/3/19
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2022
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: 220
• Est. completion date: December 1, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• IUCD Complication

Intervention

Drug:
• INH
3 vaginal tablet of isonicotinic acid hydrazide (900mg) inserted by the study nurse 4 hours before IUD insertion.
• Placebo Comparator
3 tablet of placebo inserted by the study nurse 4 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