Effect of Implantable Contraception on Type-2 DM and Metabolic Syndrome in Women With History of Gestational DM

Not Applicable

• Conditions: Metabolic Syndrome; Diabetes Mellitus
• Interventions: Device: progestin implant; Device: Placebo

• Registration Number: NCT02114476
• Lead Sponsor: Mahidol University

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.

Detailed Description

Gestational diabetes mellitus (GDM) was defined as abnormal glucose tolerance detected for the first time in pregnancy. GDM is a well-known risk factor for developing overt diabetes later in life, especially type 2 diabetes. About 50-60% of woman with prior GDM will develop type 2 diabetes during their lifetime. Recent studies show that women with previous GDM exhibit a markedly increased prevalence of the metabolic syndrome, even when glucose tolerance is normal. For both maternal and future offspring, women with prior GDM need safe, efficient, and acceptable choices for contraceptive methods that do not enhance their already substantial risk to develop either overt diabetes or metabolic syndrome and associated sequelae. The intrauterine device (IUD) is a very effective and reversible contraceptive method without metabolic disturbances and therefore is an ideal contraceptive for women with prior GDM. Progestins do not increase globulin production; thus, they do not increase coagulation factors or blood pressure. A nonrandomized open-label prospective trial of healthy obese, reproductive-age women in California were studied about the metabolic effects of progestin-only long-acting reversible contraception levonorgestrel-releasing intrauterine system (LNG-IUS) and etonogestrel implant (ENG-I)\] comparing with nonhormonal contraception (NHC). The changes in fasting glucose and insulin sensitivity were seen among obese at 3 months.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-11
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-15
• Primary Completion: 2017-03
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
progestin implant	progestin implant	Jadelle
nonhormonal contraception	Placebo	nonhormonal intrauterine device tubal sterilization

Primary Outcome Measures

Name	Time	Method
Diabetes mellitus	5 years	Incidence of type-2 DM in women with history of gestational diabetes using implantable contraception.

Secondary Outcome Measures

Name	Time	Method
metabolic syndrome	5 years	Prevalence of metabolic syndrome in women with history of gestational diabetes using implantable contraception.

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand