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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-08-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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IUCD Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double blind randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

double blind randomized controlled trial

Study Groups

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dinoprostone

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

Group Type EXPERIMENTAL

dinoprostol

Intervention Type DRUG

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

misoprostol

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

Group Type ACTIVE_COMPARATOR

misoprostol

Intervention Type DRUG

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

placebo

Placebo Comparator: placebo 2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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dinoprostol

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

Intervention Type DRUG

misoprostol

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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prostin Misotac placebo comparator

Eligibility Criteria

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Inclusion Criteria

* multi parous women requesting copper IUD insertion
* body mass index more than 25

Exclusion Criteria

* pregnancy,
* null parous women,
* contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion,
* untreated active cervicitis or vaginitis,
* undiagnosed abnormal uterine bleeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No