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

Cairo University210 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

210

Conditions

Contraception

Interventions

vaginal dinoprostoneDRUG

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

Lidocaine-prilocaine CreamDRUG

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

placeboDRUG

inert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * nulliparous women requesting copper IUD insertion Exclusion Criteria: * multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.

Outcomes

Primary Outcomes

pain during IUD insertion: visual analog scale

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

Time frame: 5 minutes

Secondary Outcomes

duration of insertion

duration of insertion from speculum in to speculum out

Time frame: 5 minutes

Central Contacts

AHMED SAMY

CONTACT

+201100681167 ahmedsamy8233@gmail.com

Data from ClinicalTrials.gov

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