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

NCT ID: NCT02114476

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2022-06-30

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.

Conditions

Diabetes Mellitus; Metabolic Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

nonhormonal contraception

nonhormonal intrauterine device tubal sterilization

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

progestin implant

Jadelle

Group Type: EXPERIMENTAL

progestin implant

Intervention Type: DEVICE

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

Interventions

progestin implant

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

Intervention Type: DEVICE

Placebo

Intervention Type: DEVICE

Other Intervention Names

Jadelle

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Manee Rattanachaiyanont

Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Manee Rattanachaiyanont, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

GDM-Imp

Identifier Type: -

Identifier Source: org_study_id