Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.

Cairo University160 enrolled

Overview

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.

Women may experience pain and technical difﬁculties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

160

Conditions

IUD Insertion

Interventions

DinoprostoneDRUG

1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by participants 3 hours before scheduled IUD insertion appointment.

placeboDRUG

one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * multiparous women aged over 18 years of age requesting an IUD for contraception, had a negative pregnancy test. Exclusion Criteria: * currently pregnant or were pregnant within 6 weeks of study entry * had a prior attempted or successful IUD insertion * had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy * any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD * active vaginitis or cervicitis * undiagnosed abnormal uterine bleeding * pelvic inﬂammatory disease within the last 3 months * ﬁbroids or other uterine abnormalities distorting the uterine cavity * contraindication or allergy to dinoprostone.

Locations (1)

faculty of medicine Cairo university

Giza, Egypt

Outcomes

Primary Outcomes

the difference in the pain intensity scores between the study groups

the difference in the pain intensity scores between the study groups by visual analog scale score which ranges from zero to 10.where zero represents no pain and 10 represents the most worst pain

Time frame: 5 minutes

Data from ClinicalTrials.gov

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