Lara C. Pullen, PhD

May 02, 2014

CHICAGO — Perforation rates are low with both levonorgestrel and copper intrauterine devices (IUDs), according to the European Active Surveillance Study for Intrauterine Devices (EURAS-IUD).

"The health benefits of IUDs outweigh the rare risk of perforation, even for women postpartum and those who are breast-feeding," said Klaas Heinemann, MD, PhD, MSc, MBA, from ZEG-Berlin in Germany.

Dr. Heinemann received a standing ovation when he presented EURAS-IUD results here at the American Congress of Obstetricians and Gynecologists (ACOG) 2014 Annual Clinical Meeting. The study won second prize at the meeting and was highlighted during a plenary session.

Uterine perforation is a potentially serious complication of IUD use. Previous studies have reported conflicting findings on the risk.

The EURAS-IUD is the largest study to date to document all potential risk factors for uterine perforation, as well as all serious adverse events. Patients were recruited from a network of approximately 2000 gynecologists.

The noninterventional study involved the active surveillance of 61,448 women from Austria, Finland, Germany, Poland, Sweden, and the United Kingdom. Levonorgestrel IUDs were used by 46% of the women and copper IUDs were used by 54%.

 
The health benefits of IUDs outweigh the rare risk of perforation.
 

The primary outcome was uterine perforation. Secondary outcomes included time between IUD insertion and uterine perforation, proportion of uterine perforations associated with IUD, and incidence of medically relevant adverse events associated with IUD use. Adjustments were made for age, body mass index, parity, time since last delivery, and experience of the healthcare provider.

The study participants — first-time and repeat users of IUDs — were 18 years or older and received a newly inserted IUD from 2006 to 2013. "The most striking difference was the age distribution," Dr. Heinemann explained; younger women favored the levonorgestrel IUD.

A year after enrolment, women and their physicians completed follow-up questionnaires. Outcomes of interest were validated by the treating physician. Because of a multifaceted 4-level follow-up procedure, loss to follow-up was low.

There were 61 perforations with the levonorgestrel IUD and 20 with the copper IUD; none of them resulted in serious sequelae.

Breast-feeding at the time of insertion was associated with a 6-fold increase in total perforation risk (relative risk, 6.1; 95% confidence interval, 3.6 - 10.1). There was no difference between the levonorgestrel and copper IUDs.

"Breast-feeding is a risk factor, as is time since last delivery," Dr. Heinemann reported.

Table. IUD Status at 1 Year

Outcome Levonorgestrel IUD Copper IUD
Retained, % 92.9 87.5
Expulsion, % 1.0 1.2
Perforations/1000 IUDs 1.4 1.1

 

"This is a huge study," said Caela Miller, MD, from the San Antonio Military Medical Center and a member of the ACOG Committee on Scientific Program.

"Both types of IUDs are safe, effective, long-term contraception options for patients," she told Medscape Medical News.

This study was governed by an independent Advisory Council to maintain independence. The study was funded by an unrestricted grant from Bayer Pharma AG. Dr. Heinemann reports financial relationships with Bayer. Dr. Miller has disclosed no relevant financial relationships.

American Congress of Obstetricians and Gynecologists (ACOG) 2014 Annual Clinical Meeting: Abstract 3S. Presented April 29, 2014.

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