Dinoprostone vs Misoprostol Before LNG-IUD Insertion

Cairo University200 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

IUD Insertion Pain

Interventions

vaginal dinoprostoneDRUG

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

vaginal misoprostolDRUG

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

placeboDRUG

two tablets of placebo given 3 hours prior to IUD insertion

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * multiparous women requesting IUD insetion Exclusion Criteria: * active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol

Outcomes

Primary Outcomes

pain during IUD insertion: visual analog scale

pain during IUD insertion assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable

Time frame: 2 minutes

Secondary Outcomes

duration of IUD insertion

duration of IUD insertion measured in minutes

Time frame: 5 minutes

Central Contacts

AHMED SAMY, MD

CONTACT

+201100681167 ahmedsamy8233@gmail.com

Data from ClinicalTrials.gov

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