Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion

Cairo University (CU)

Status and phase: Unknown; Phase 3

Conditions: Contraception

Treatments: Drug: placebo; Drug: vaginal dinoprostone; Drug: Lidocaine-prilocaine Cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04340778

dinoprostone vs LP cream

Details and patient eligibility

About

the aim of the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial

Enrollment: 210 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• nulliparous women requesting copper IUD insertion

Exclusion criteria

• multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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210 participants in 3 patient groups, including a placebo group

vaginal dinoprostone

Experimental group

Description:

vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion.

Treatment:

Drug: vaginal dinoprostone

lidocaine prilocaine cream

Active Comparator group

Description:

Lidocaine-prilocaine Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion

Treatment:

Drug: Lidocaine-prilocaine Cream

placebo

Placebo Comparator group

Description:

inert placebo Cream will be applied on the cervix at the time of copper IUD insertion plus vaginal placebo tablet 3 hours before IUD insertion

Treatment:

Drug: placebo