IUD at Cesarean Delivery (PIXIE): a study comparing Mirena® IUD insertion at delivery versus 4-8 weeks following delivery

IRB #: 15148A
Summary: The IUD is an excellent method of contraception and is appealing for use in the post-partum period. Yet, the current standard of care is to wait to insert the IUD until the post-partum check-up or even later. Unfortunately, many women do not return for this visit and therefore do not get the IUD inserted. Immediate postplacental IUD insertion, i.e. insertion of the IUD within 10 minutes of delivery of the placenta, has the potential to address this problem and to increase IUD use in the post-partum period. This research study will compare the use of a type of intrauterine device (IUD), the levonorgestrel-releasing intrauterine system (Mirena® IUD or LNG-IUS) inserted immediately after delivery of the placenta during cesarean delivery versus the use of the Mirena® IUD placed 4-8 weeks following your cesarean section. The study will also examine differences in overall satisfaction with the method, expulsion (when the IUD comes out of the uterus on its own), menstrual periods and bleeding, other side effects and complications, pregnancy, and quality of life.
Women involved in this trial must be 18 years and older.  Participants will be randomly assigned to either insertion of the IUD at the time of delivery or insertion 4-8 weeks later at their regular postpartum visit. Women are required to follow up at the University of Chicago clinic four times after their delivery (1, 3, 6, and 12 months after delivery) and receive up to $120 for the completion of all study visits and questionnaires.

If you are interested in this study and would like more information, please call our Family Planning Research Line: 773-834-7727

Principle Investigator:
Amy Whitaker MD,MS
Co-Investigators:
Melissa Gilliam MD MPH
Katie Sisco MD
Sigrid Tristan MD

Predictors of Complications of Second Trimester
Surgical Abortion From 14-18 Weeks Gestation

IRB #: 16907A
Summary: The aim of this study is to improve our understanding of the complications of D&E procedures.  Using a retrospective review of approximately 1500 charts, we will collect data on all complications that have occurred over a two-year period at two Planned Parenthood sites and one hospital-based clinic and collect data on those factors that are associated with an increased risk of complication. We aim to describe the frequency and predictors of complication at abortion. Better understanding of those factors that place women at risk for abortion complications may provide insight for future improvement in safety and quality.

Principle Investigator
Melissa Gilliam MD MPH
Co-Investigator
Sigrid Tristan, MD