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

Cairo University210 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

210

Conditions

Contraception

Interventions

vaginal misoprostolDRUG

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

Lidocaine-Prilocaine Topical creamDRUG

Lidocaine-Prilocaine cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion

placeboDRUG

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

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ahmedsamy

Giza, Egypt

Outcomes

Primary Outcomes

pain during LNG-IUD insertion

pain during LNG-IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst imaginable pain

Time frame: 5 minutes

Secondary Outcomes

duration of insertion

duration of LNG-IUD insertion from speculum in to speculum out

Time frame: 5 minutes

Data from ClinicalTrials.gov

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