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

Aswan University Hospital220 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

220

Conditions

IUCD Complication

Interventions

INHDRUG

3 vaginal tablet of isonicotinic acid hydrazide (900mg) inserted by the study nurse 4 hours before IUD insertion.

Placebo ComparatorDRUG

3 tablet of placebo inserted by the study nurse 4 hours before IUD insertion.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Aswan University Hospital

Aswān, Egypt

Outcomes

Primary Outcomes

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

Time frame: 10 minutes

Secondary Outcomes

duration of IUD insertion

duration of IUD insertion measured in minutes

Time frame: 10 minutes

Data from ClinicalTrials.gov

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