Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion

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

2021-09-30

Brief Summary

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

randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

randomized controlled trial

Study Groups

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isonicotinic acid hydrazide

2vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.

Group Type EXPERIMENTAL

Isonicotinic Acid Hydrazide

Intervention Type DRUG

2 vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.

dinoprostone

2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) inserted by the study nurse 12 hours before IUD insertion.

Group Type ACTIVE_COMPARATOR

dinoprostine

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 12hours 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

Interventions

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Isonicotinic Acid Hydrazide

2 vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.

Intervention Type DRUG

dinoprostine

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

Other Intervention Names

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INH prostin Misotac

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No