Dinoprostone vs Misoprostol Before LNG-IUD Insertion

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: IUD Insertion Pain

Treatments: Drug: placebo; Drug: vaginal misoprostol; Drug: vaginal dinoprostone

Study type: Interventional

Funder types: Other

Identifiers

NCT04301349

dinoprostone IUDs

Details and patient eligibility

About

the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain

Enrollment: 200 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• multiparous women requesting IUD insetion

Exclusion criteria

• active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 3 patient groups, including a placebo group

vaginal dinoprostone

Experimental group

Description:

vaginal dinoprostone 6 mg (two tablets) 3 hours prior to IUD insertion

Treatment:

Drug: vaginal dinoprostone

vaginal misoprostol

Active Comparator group

Description:

vaginal misoprostol 400 mcg (two tablets) 3 hours prior to IUD insertion

Treatment:

Drug: vaginal misoprostol

placebo

Placebo Comparator group

Description:

two tablets of placebo similar in shape ,color, odor to the study drugs

Treatment:

Drug: placebo