NCT02054195

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

1.1 years

First QC Date

January 25, 2014

Last Update Submit

February 1, 2014

Conditions

Intra-uterine Device Complication

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with IUD total or partial expulsion

    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.

    12 Months

Secondary Outcomes (1)

  • Percentage of Participants with retained skill and knowledge

    12 Months

Study Arms (2)

IUD new technique

EXPERIMENTAL

Training

Behavioral: Training

No Training

EXPERIMENTAL

No Training

Behavioral: No Training

Interventions

TrainingBEHAVIORAL

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.

IUD new technique
No TrainingBEHAVIORAL

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

No Training

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Any bleeding and infection complication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central nationalHospital Cipto Mangunkusumo

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

Location

Study Officials

  • Seno Adjie, MD, PhD

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 25, 2014

First Posted

February 4, 2014

Study Start

August 1, 2012

Primary Completion

September 1, 2013

Study Completion

October 1, 2013

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

ID(1)