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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04500028

Enrollment

220

Registered

2020-08-05

Start date

2020-08-01

Completion date

2021-12-01

Last updated

2022-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUCD Complication

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.

Interventions

DRUGINH

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

DRUGPlacebo Comparator

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

double blind randomized controlled trial

Intervention model description

double blind randomized controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
duration of IUD insertion	10 minutes	duration of IUD insertion measured in minutes

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026