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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: IUD Insertion Complication

Treatments: Drug: Dinoprostone; Drug: placebo; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04080336

dinoprostone misoprostol IUD

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 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: 129 patients

Sex: Female

Ages: 18+ 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: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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129 participants in 3 patient groups, including a placebo group

dinoprostone

Experimental group

Description:

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

Treatment:

Drug: Dinoprostone

misoprostol

Active Comparator group

Description:

1 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:

one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Treatment:

Drug: placebo