Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of this multi-center clinical trial is to evaluate the safety and effectiveness of inserting an intrauterine device (IUD) immediately after a suction aspiration procedure compared to inserting the IUD 2-6 weeks after the procedure. This study will also evaluate how satisfied women are with the timing of their IUD placement. Subjects will be able to choose between the Paraguard IUD or the Mirena IUD. The researchers hypothesize that: the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with immediate insertion compared with delayed insertion, satisfaction and tolerance of side effects will be higher with immediate IUD insertion compared with delayed insertion, and overall IUD use/continuation rates measured at 1, 3 and 6 months will be higher with immediate IUD insertion compared with delayed insertion.

Official Title
-----------------
Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial

Conditions
-----------------
Contraception

Intervention / Treatment
-----------------
* Procedure: Immediate IUD insertion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 18 years or older Requesting suction aspiration for spontaneous or elective abortion Intrauterine pregnancy documented with ultrasound. For women with a gestational sac, the gestational age (EGA) must be ≥ 5 weeks 0 days but ≤ 12 weeks 0 days based on the following criteria: If no embryonic pole present: EGA (days) = mean sac diameter (mm) + 30 (Mean sac diameter =[length+width+depth]/3) If embryonic pole is present: EGA (days) determined by Hadlock scale for measured crown-rump length Desiring intrauterine contraception In general good health Willing and able to undergo informed consent Willing to comply with randomization and study follow-up schedule Exclusion Criteria: Pelvic exam with evidence of active cervicitis or PID (eg. purulent discharge, adnexal mass, significant cervical or uterine tenderness) PID or sexually transmitted infection within the previous three months History of pelvic Actinomyces Unexplained vaginal bleeding Uterine anomaly (eg. bicornuate uterus) Leiomyomata that distort the uterine cavity Known or suspected complete molar pregnancy Current confirmed or possible ectopic pregnancy AIDS without treatment (individuals with HIV/AIDS who are clinically well are not excluded) Any prior surgical aspiration during this current pregnancy Use of osmotic dilators (eg. laminaria) or misoprostol for cervical preparation during the aspiration procedure Allergy to polyethylene Allergy to levonorgestrel (for levonorgestrel-containing IUS only) Allergy to copper (for copper T380A IUD only) Wilson's disease (for copper T380A IUD only) Current participation in another research study which would interfere with the conduct of this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Immediate IUD insertion following suction aspiration between 5 and 12 weeks gestation | Procedure: Immediate IUD insertion<br>* Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation<br>|
| No Intervention: 2<br>Delayed IUD insertion 2-6 weeks following suction aspiration between 5 and 12 weeks gestation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IUD expulsion |  | 1, 3 and 6 months after insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IUD continuation |  | 1, 3 and 6 months after insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IUD, insertion timing