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

Overview

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.

Full Title of Study: “Effect of Implantable Progestin-only Contraception on the Incidence of Type 2 Diabetes and Metabolic Syndrome in Thai Women With History of Gestational Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2017

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.

Interventions

  • Device: progestin implant
    • two small (2.5 mm × 43 mm) silicone rods each containing 75 mg of levonorgestrel in a polymer matrix
  • Device: Placebo

Arms, Groups and Cohorts

  • Placebo Comparator: nonhormonal contraception
    • nonhormonal intrauterine device tubal sterilization
  • Experimental: progestin implant
    • Jadelle

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • metabolic syndrome
    • Time Frame: 5 years
    • Prevalence of metabolic syndrome in women with history of gestational diabetes using implantable contraception.

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mahidol University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Manee Rattanachaiyanont, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital – Mahidol University
  • Overall Official(s)
    • Manee Rattanachaiyanont, MD, Principal Investigator, Mahidol University

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