Skip to content

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

Effect of Implantable Progestin-only Contraception on the Incidence of Type 2 Diabetes and Metabolic Syndrome in Thai Women With History of Gestational Diabetes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02114476
Enrollment
260
Registered
2014-04-15
Start date
2014-03-31
Completion date
2022-06-30
Last updated
2018-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Metabolic Syndrome

Keywords

GDM, implant, diabetes mellitus, metabolic syndrome

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.

Interventions

DEVICEprogestin implant

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

DEVICEPlacebo

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Diabetes mellitus5 yearsIncidence of type-2 DM in women with history of gestational diabetes using implantable contraception.

Secondary

MeasureTime frameDescription
metabolic syndrome5 yearsPrevalence of metabolic syndrome in women with history of gestational diabetes using implantable contraception.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026