NCT03140800

Brief Summary

Intrauterine contraceptive device is one of the most efficient and reversible methods of birth control with low cost and long duration of use However, in the first year after insertion, between 5 and 15% of women will have their Intrauterine contraceptive device removed because of irregular uterine bleeding which have been attributed to the effect of contact between the device and the endometrium and even the pressure on the uterine muscle . The disharmonious relationship between the Intrauterine contraceptive device and the uterus is the cause of most of the bleeding complaints, so bleeding is related to improper position rather than the contraceptive method itself which should be excluded before abandoning the Intrauterine contraceptive device for any other method of birth control

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Status
unknown

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

First Submitted

Initial submission to the registry

May 3, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 4, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

May 3, 2017

Last Update Submit

May 3, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • The intrauterine device-Endometrial distance

    3 months

Interventions

a method of contraception inserted in the uterus

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients using intrauterine contraceptive device complaining of bleeding

You may qualify if:

  • patients using intrauterine contraceptive device complaining of bleeding

You may not qualify if:

  • a-Associated uterine, cervical,or adenexal pathology b-Associated pelvic infection c-Generalized bleeding disorders d-Medications causing coagulation defects e-Medical disorders causing bleeding e.g hypertention f-Endocrine disorder as thyroid dysfunction g-Who refuse to share in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Intrauterine Devices

Intervention Hierarchy (Ancestors)

Contraceptive Devices, FemaleContraceptive DevicesEquipment and Supplies

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 4, 2017

Study Start

June 1, 2017

Primary Completion

August 1, 2018

Study Completion

March 1, 2019

Last Updated

May 4, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share