Training Model on Insertion Techniques for Postplacental Intra Uterine Device

Phase 4

Completed

• Conditions: Intra-uterine Device Complication
• Interventions: Behavioral: Training; Behavioral: No Training

• Registration Number: NCT02054195
• Lead Sponsor: Showa University

Brief Summary

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

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

Study Timeline

• Study Start: 2012-08
• Primary Completion: 2013-09
• Study Completion: 2013-10
• Study First Submitted: 2014-01-25
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-01
• Last Update Submitted: 2014-02-01
• Study First Posted: 2014-02-04
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 230

Inclusion Criteria

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

Exclusion Criteria

• Any bleeding and infection complication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IUD new technique	Training	Training
No Training	No Training	No Training

Primary Outcome Measures

Name	Time	Method
Number of Participants with IUD total or partial expulsion	12 Months	Transabdominal ultrasonography examination was done by researcher right after insertion. Ultrasonography examination was done using longitudinal and transversal scan, with client in supine position using real time convex 2 probe with 3,5 Mhz frequency. While transvaginal ultrasonography examination was done when the client come after 6 weeks, 6 months and 12 months after insertion.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants with retained skill and knowledge	12 Months

Trial Locations

Locations (1)

Central nationalHospital Cipto Mangunkusumo; 🇮🇩 Jakarta, Indonesia