Status:Recruiting
Keywords:Difficult IUD insertions
IRB Number:00054228
Specialty:OB/Gyn, General
Sub Specialty:General Obstetrics
In currently published literature there are little data regarding effective interventions to reduce IUD insertion failure rates. There are also little data regarding patient characteristics, other than nulliparity, that may predict difficult insertions. In addition, in most IUD studies insertions were performed by experienced physician providers. Non-physicians included in these studies often work in major academic centers and are not necessarily representative of providers in the community. Sessions held at recent national meetings demonstrate that challenging insertions are something providers regularly confront and see as a significant issue.
Currently, advanced practice clinicians (APCs) provide a majority of the contraceptive care at family planning clinics nationwide. However, preliminary data from a study of copper IUDs at Utah family planning clinics shows an insertion failure rate ranging from 15-20%. Currently published failure rates range from <1-10%. Further investigation into this higher failure rate among APCs is necessary, as is development of an effective strategy to manage difficult IUD insertions. This study aims to determine if a training program for APCs, focused on the use of cervical dilation and paracervical blocks for difficult IUD insertions, will improve IUD insertion success. In addition we aim to gather data that might identify patient risk factors for difficult insertions
The study will be a prospective, non-randomized trial and will take place at Planned Parenthood Association of Utah (PPAU) clinics. The study will take place over 3 periods. Period 1 will be a prospective observation of all insertions under the current standard of care at PPAU, which does not involve the use of adjunctive measures. Period 2 will be the intervention, during which providers will receive training in management of difficult insertions, including use of cervical dilation and paracervical block. Period 3 will be an observation of post-intervention IUD insertions. Providers will be recruited from employees at PPAU. Patient subjects will be recruited from among women aged 18-44 presenting for IUD insertion. Projected sample size needed to detect a 7% difference in insertion rates post intervention with 80% power is 512 (256 in each arm). The study is projected to take place over 12 months.
Principle Investigator: Amna Dermish
Principle Department: OB/GYN Research Network
Co Investigator:
Name:Amna Dermish
Phone:801-213-2745
Email:Amna.dermish@hsc.utah.edu
Eligible provider participants must be advanced practice clinicians who have completed their training and are currently employed by PPAU. This includes Physician Assistants, Nurse Practitioners, and Certified Nurse Midwifes.
Eligible patient participants will include any woman aged 18-44 presenting to PPAU for an IUD insertion.
Exclusion criteria for patients include: current pregnancy, intrauterine infection in preceding 3 months, undiagnosed abnormal vaginal bleeding, known Gonorrhea or Chlamydia infection in the last 30 days (unless successfully treated at least 7 days prior to study entry), allergy to LNG (for LNG IUD patients) or allergy to copper or Wilson's disease (for Copper IUD patients) or known abnormalities of the uterus that distort the uterine cavity.
