Misoprostol Prior to Intrauterine Device Insertion

NCT ID: NCT04932382

Last Updated: 2023-05-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-03-01

Brief Summary

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The intrauterine device (IUD) is a reliable, safe, long acting, and effective contraceptive method . In spite of that, the pain associated with IUD insertion can be a cause against its insertion. Many researches have been conducted aiming to decrease the degree of pain during IUD insertion; these studies included medical and also technical methods.

The physicians usually prefer to insert the IUD during women's menses because the women are very unlikely to be pregnant and the insertion is easier and the pain is lower The easiness of IUD insertion is a very important issue that can increase women's satisfaction and decrease insertion pain.

Detailed Description

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Conditions

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IUD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Misoprostol group

400 µg misoprostol vaginally ; these tablets will be introduced by the principal investigator, digitally without using speculum, 3 hours before IUD insertion into the posterior vaginal fornix of the woman while lying in the lithotomy position

Group Type OTHER

Misoprostol

Intervention Type DRUG

will be used 3 h before IUD insertion

IUD

Intervention Type DEVICE

a copper T380A IUD

No misoprostol group

will not receive any pre-insertion medications.

Group Type OTHER

IUD

Intervention Type DEVICE

a copper T380A IUD

Interventions

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Misoprostol

will be used 3 h before IUD insertion

Intervention Type DRUG

IUD

a copper T380A IUD

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women aged 18-45 years
* Non-pregnant women
* Women who will come when there are non-menstruating.

Exclusion Criteria

* Women received any analgesics or misoprostol in the 24 hours prior to insertion
* Women with any contraindications for IUD insertion
* Nulliparous women
* Women refuse to participate.
* Women have any contraindication of misoprostol.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Khairy Ali

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Women Health Hospital - Assiut university

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MISO-IUD

Identifier Type: -

Identifier Source: org_study_id

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