• Contraception Clinical Trials

• Contraception
• Obstetrics & Gynecology Clinical Trials
• Obstetrics & Gynecology

The risk of perforation from the use of intrauterine devices (IUDs) is low and similar for levonorgestrel-releasing (LNG) IUDs and copper IUDs. Compared with copper IUDs, however, LNG-IUDs were noted to have a significant reduction in the incidence of pregnancy, including a marked reduction in ectopic pregnancy.

Klaas Heinemann, MD, PhD, MBA, of the Berlin Center for Epidemiology and Health Research, Berlin, Germany, presented the results of the European Active Surveillance Study for Intrauterine Devices (EURAS-IUD; NCT0046/1175), a large, multinational, prospective, controlled, noninterventional study, conducted to compare the risk of perforation during and after insertion of 2 types of IUDs: LNG-IUDs and copper IUDs.

Between 2006 and 2013, more than 60,000 women from 6 European countries were enrolled in the study and divided into 2 cohorts: those using LNG-IUDs (n=43078) and those using copper IUDs (n=18370).

Baseline characteristics between the 2 cohorts were comparable in body mass index, educational level, and medical and gynecological history. When stratified by age (<20 years, 20 to <30 years, 30 to <40 years, and ≥40 years), copper IUDs were used more often in women aged 20 to <30 years old (32% vs 15.9% for LNG-IUDs), and LNG-IUDs were used more often in women ≥40 years (43.6% vs 23.6% for copper IUDs). Women using copper IUDs also had higher rates of delivery at 12 months prior to IUD insertion (28.7% vs 19.8% for LNG-IUDs) and of breastfeeding at the time of insertion (14.6% vs 9.2% for LNG-IUDs).

To compare the perforation risk between the 2 cohorts, women and their attending physicians were asked to complete a questionnaire at 12 months following IUD insertion. Along with documenting perforation or expulsion rates, the questionnaire also required documentation of IUD removal; adverse events, including pregnancy; and breastfeeding status.

At 12-month follow-up, the study found a total of 81 perforations in both cohorts with a comparable rate of perforations between the 2 cohorts. Women with the LNG-IUDs had 61 perforations (1.4 per 1000 insertions), and those with copper IUDs had 20 perforations (1.4 per 1000 insertions). After adjusting for risk factors (eg, age, body mass index, parity, time of last delivery), the incidence rates of perforations were 1.42 for LNG-IUD users and 1.09 for copper IUD users, representing a relative risk of 1.61 (95% CI, 0.96 to 2.70).

Dr. Heinemann emphasized that all perforations had benign outcomes, and none led to serious side effects.

Although the study showed no clinically relevant risk of perforations with either IUD type, Dr. Heinemann emphasized that drawing conclusions on the magnitude of the differences between the 2 IUD types in terms of perforation rates was difficult based on the observational design of the trial.

He did, however, highlight further findings of the study that showed that the use of LNG-IUDs was associated with a 10-fold reduction in the incidence of pregnancy as well as a marked reduction in ectopic pregnancy, compared with copper IUDs. Additional findings showed breastfeeding as a significant risk factor for perforation.

• © 2014 MD Conference Express®