Immediate Versus Delayed Intrauterine Device (IUD) Insertion Following First Trimester Suction Aspiration Procedures - Full Text View

Sponsored by:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00562276

Purpose

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.

Condition	Intervention	Phase
Contraception	Procedure: Immediate IUD insertion	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	Immediate Versus Delayed IUD Insertion Following Suction Aspiration Between 5 and 12 Weeks Gestation: a Randomized Trial

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

IUD expulsion [ Time Frame: 1, 3 and 6 months after insertion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IUD continuation [ Time Frame: 1, 3 and 6 months after insertion ] [ Designated as safety issue: No ]

Enrollment:	578
Study Start Date:	May 2007
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Immediate IUD insertion following suction aspiration between 5 and 12 weeks gestation	Procedure: Immediate IUD insertion Insertion of either Paraguard or Mirena IUD within minutes of completing suction aspiration procedure between 5 and 12 weeks gestation
2: No Intervention Delayed IUD insertion 2-6 weeks following suction aspiration between 5 and 12 weeks gestation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562276

Locations

United States, Georgia
Emory University
Atlanta, Georgia, United States
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States
United States, Pennsylvania
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:

Paula H Bednarek, MD

Oregon Health and Science University

More Information

No publications provided

Responsible Party:	OHSU ( Paula Bednarek, MD, MPH )
Study ID Numbers:	OHSU FAMPLAN 2535
Study First Received:	November 21, 2007
Last Updated:	August 21, 2009
ClinicalTrials.gov Identifier:	NCT00562276 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

IUD
insertion timing

Study placed in the following topic categories:

Levonorgestrel

ClinicalTrials.gov processed this record on September 10, 2009