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

Aswan University Hospital

Status and phase: Completed; Phase 4

Conditions: IUCD Complication

Treatments: Drug: INH; Drug: Placebo Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT04500028

aswu/355/3/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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220 participants in 2 patient groups, including a placebo group

INH

Experimental group

Description:

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

Treatment:

Drug: INH

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Comparator