Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion

Aswan University Hospital

Status: Unknown

Conditions: IUCD Complication

Treatments: Drug: misoprostol; Drug: dinoprostine; Drug: Isonicotinic Acid Hydrazide

Study type: Interventional

Funder types: Other

Identifiers

NCT04505943

aswu/352/5/19

Details and patient eligibility

About

To compare the effect of vaginal dinoprostone versus vaginal misoprostol and Isonicotinic Acid Hydrazide administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous 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: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• nulliparous women requesting copper IUD insertion

Exclusion criteria

• pregnancy,
• Parous women,
• contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
• untreated active cervicitis or vaginitis,
• undiagnosed abnormal uterine bleeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 3 patient groups

isonicotinic acid hydrazide

Experimental group

Description:

2vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.

Treatment:

Drug: Isonicotinic Acid Hydrazide

dinoprostone

Active Comparator group

Description:

2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 12 hours before IUD insertion.

Treatment:

Drug: dinoprostine

misoprostol

Active Comparator group

Description:

2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 12hours before IUD insertion.

Treatment:

Drug: misoprostol