Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women

Aswan University Hospital

Status: Unknown

Conditions: IUCD Complication

Treatments: Drug: placebo; Drug: misoprostol; Drug: dinoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04505917

aswu/352/4/19

Details and patient eligibility

About

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in multiparous overweight and obese 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

• multi parous women requesting copper IUD insertion
• body mass index more than 25

Exclusion criteria

• pregnancy,
• null 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: Quadruple Blind

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200 participants in 3 patient groups, including a placebo group

dinoprostone

Experimental group

Description:

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

Treatment:

Drug: dinoprostol

misoprostol

Active Comparator group

Description:

2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

Treatment:

Drug: misoprostol

placebo

Placebo Comparator group

Description:

Placebo Comparator: placebo 2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Treatment:

Drug: placebo