Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Lidocaine-Prilocaine Topical cream; Drug: placebo; Drug: vaginal misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04339348

misoprostol vs LP cream

Details and patient eligibility

About

the aim of the present study is to compare the safety and Efficacy of vaginal misoprostol versus Lidocaine-prilocaine cream in reducing pain during levonorgestrel IUD Insertion in women delivered only by cesarean deliveries

Enrollment: 210 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• women who delivered only by previous cesarean delivery and requesting LNG-IUD insertion

Exclusion criteria

• women who delivered vaginally, active vaginal or cervical infections and contraindications to IUD insertion or study drugs

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 misoprostol

Experimental group

Description:

vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus vaginal inert placebo cream at the time of IUD insertion

Treatment:

Drug: vaginal misoprostol

lidocaine prilocaine cream

Active Comparator group

Description:

Lidocaine-prilocaine anesthetic cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo will be given 3 hours before LNG-IUD insertion

Treatment:

Drug: Lidocaine-Prilocaine Topical cream

placebo

Placebo Comparator group

Description:

inert vaginal placebo cream will be placed on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours before LNG-IUD insertion

Treatment:

Drug: placebo