Vaginal Isonicotinic Acid Hydrazide (INH) Administration Prior to T380A 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

NCT04499989

aswu/353/4/19

Details and patient eligibility

About

To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery.

Full description

Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device is attempted through a narrow cervical canal. intrauterine device insertion- related complications and side effects are more common among women who had never delivered vaginally.

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 as congenital anomalies, endometrial lesions, adenomyosis, 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 .
• 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 self-inserted by the patient 12 hours before IUD insertion.

Treatment:

Drug: INH

Placebo Comparator

Placebo Comparator group

Description:

3 vaginal tablet of Placebo Comparator self-inserted by the patient 12 hours before IUD insertion.

Treatment:

Drug: Placebo Comparator