the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion

Phase 3CompletedNCT04312048

Cairo University110 enrolled

Overview

The aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

110

Conditions

IUD Insertion Pain

Interventions

Isosorbide mononitrateDRUG

one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion

placeboDRUG

one tablet of placebo vaginally 3 hours prior to copper IUD insertion

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: * nulliparous women requesting copper IUD device insertion Exclusion Criteria: * parous women, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly

Locations (1)

Ahmed Samy

Giza, Egypt

Outcomes

Primary Outcomes

pain during IUD insertion

intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 100 on a 100 mm horizontal straight line, where 'zero' corresponds to no pain at all, and '100' to the worst possible pain imaginable.

Time frame: 5 minutes

Secondary Outcomes

duration of IUD insertion

duration of IUD insertion from speculum in to speculum out

Time frame: 5 minutes

Data from ClinicalTrials.gov

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