Training Model on Insertion Techniques for Postplacental Intra Uterine Device

NCT ID: NCT02054195

Last Updated: 2014-02-04

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

PHASE4

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-10-31

Brief Summary

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This study aimed to compare special guided training model with standard procedure on insertion technique for post-placental intra uterine device that provides IUD location close enough to fundal part of uterus to prevent expulsion

Detailed Description

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The standard of insertion IUD postplacental can not provide prevention of expulsion. Special techniques on insertion IUD is needed for preventing expulsion. This training model is consisted of the special techniques to provide intra uterine device post placental close enough to fundal part of uterus to prevent expulsion

Conditions

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Intra-uterine Device Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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IUD new technique

Training

Group Type EXPERIMENTAL

Training

Intervention Type BEHAVIORAL

Training model is consist of effort to provide intra uterine device post placental by organising a special guided training model for post-placental IUD insertion by pushing the head of IUD using index and middle finger close enough to fundal part of uterus to prevent expulsion.

No Training

No Training

Group Type EXPERIMENTAL

No Training

Intervention Type BEHAVIORAL

Control of Training model is without training on effort of pushing the head of IUD using index and middle finger to uterine fundus.

Interventions

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Training

Training model is consist of effort to provide intra uterine device post placental by organising a special guided training model for post-placental IUD insertion by pushing the head of IUD using index and middle finger close enough to fundal part of uterus to prevent expulsion.

Intervention Type BEHAVIORAL

No Training

Control of Training model is without training on effort of pushing the head of IUD using index and middle finger to uterine fundus.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 37-42 weeks gestation pregnancy women in delivery, singleton pregnancy, without any uterine anomaly

Exclusion Criteria

* Any bleeding and infection complication
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Showa University

OTHER

Sponsor Role lead

Responsible Party

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Yuditiya Purwosunu

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seno Adjie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Central nationalHospital Cipto Mangunkusumo

Jakarta, Jakarta Special Capital Region, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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jm1

Identifier Type: -

Identifier Source: org_study_id

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