NCT02114476

Brief Summary

The purpose of this study is to determine the effect of implantable contraception on the incidence of diabetes mellitus in women with history of gestational diabetes mellitus comparing with those using nonhormonal contraceptives.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

April 11, 2014

Last Update Submit

August 20, 2018

Conditions

Diabetes MellitusMetabolic Syndrome

Keywords

GDMimplantdiabetes mellitusmetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • Diabetes mellitus

    Incidence of type-2 DM in women with history of gestational diabetes using implantable contraception.

    5 years

Secondary Outcomes (1)

  • metabolic syndrome

    5 years

Study Arms (2)

nonhormonal contraception

PLACEBO COMPARATOR

nonhormonal intrauterine device tubal sterilization

Device: Placebo

progestin implant

EXPERIMENTAL

Jadelle

Device: progestin implant

Interventions

progestin implantDEVICE

two small (2.5 mm × 43 mm) silicone rods each containing 75 mg of levonorgestrel in a polymer matrix

Also known as: Jadelle
progestin implant
PlaceboDEVICE
nonhormonal contraception

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Postpartum women with diagnosis of gestational diabetes mellitus
  • Want to use implant contraception or nonhormonal contraceptions such as IUD or tubal sterilization

You may not qualify if:

  • Age less than 18 years old
  • Diagnosis of diabetes mellitus at post partum period
  • Cardiovascular disease, Liver disease, autoimmune disease
  • The women that reject to continue in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Diabetes MellitusMetabolic Syndrome

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

  • Manee Rattanachaiyanont, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital

Study Record Dates

First Submitted

April 11, 2014

First Posted

April 15, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2017

Study Completion

June 1, 2022

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations

TH(1)