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Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Phase 4

Conditions

IUD Insertion Pain

Treatments

Drug: placebo
Drug: Dinoprostone

Study type

Interventional

Funder types

Other

Identifiers

NCT04079140
vaginal dinoprostone IUD

Details and patient eligibility

About

To investigate whether vaginal dinoprostone administered before the levonorgestrel-releasing intrauterine system(IUs) 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 22 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 dinoprostone or contraindication to IUD insertion, chronic pelvic pain,pelvic inflammatory disease,analgesic intake 24 hours prior to IUD insertion.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

130 participants in 2 patient groups, including a placebo group

dinoprostone
Experimental group
Description:
1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.
Treatment:
Drug: Dinoprostone
placebo
Placebo Comparator group
Description:
one tablet of placebo self-administered by the patient 12 hours before IUD insertion.
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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