Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women

Cairo University129 enrolled

Overview

To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

129

Conditions

IUD Insertion Complication

Interventions

DinoprostoneDRUG

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 3hours before IUD insertion.

MisoprostolDRUG

1 vaginal tablet of misoprostol (200mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.

placeboDRUG

one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * nulliparous women requesting copper IUD insertion Exclusion Criteria: * pregnancy, Parous women, contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion, untreated active cervicitis or vaginitis, undiagnosed abnormal uterine bleeding

Locations (1)

Ahmed Samy

Giza, Egypt

Outcomes

Primary Outcomes

The difference in pain scores during intrauterine device insertion

The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10

Time frame: 10 minutes

Secondary Outcomes

the difference in pain scores during tenaculum application

The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10

Time frame: 10 minutes

the difference in pain scores during sound insertion

The difference in pain scores during sound insertion using a visual analog scale from 0 to 10

Time frame: 10 minutes

the ease of IUD insertion

the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion)

Time frame: 10 minutes

women's satisfaction level

women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction

Time frame: 10 minutes

Data from ClinicalTrials.gov

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