Vaginal Isonicotinic Acid Hydrazide Administration Prior to Intrauterine Device Insertion

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

NCT04500015

aswu/354/4/19

Details and patient eligibility

About

To investigate whether vaginal isonicotinic acid hydrazide administered before the levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.

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: 130 patients

Sex: Female

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• nulliparous adolescent and young women requesting levonorgestrel-releasing intrauterine device

Exclusion criteria

• pregnancy and
• contraindication or allergy to or contraindication to IUD insertion,
• chronic pelvic pain,
• pelvic inflammatory disease,
• analgesic intake 24 hours prior to IUD insertion.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 2 patient groups, including a placebo group

INH

Experimental group

Description:

3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.

Treatment:

Drug: INH

Placebo Comparator

Placebo Comparator group

Description:

3 tablet of placebo self-administered by the patient 12 hours before IUD insertion

Treatment:

Drug: Placebo Comparator