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

September 12, 2012 updated by: Paula Bednarek, Oregon Health and Science University

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

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:

  1. the expulsion rates measured at 1, 3 and 6 months will be clinically equivalent with immediate insertion compared with delayed insertion,
  2. satisfaction and tolerance of side effects will be higher with immediate IUD insertion compared with delayed insertion, and
  3. overall IUD use/continuation rates measured at 1, 3 and 6 months will be higher with immediate IUD insertion compared with delayed insertion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

578

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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
No Intervention: 2
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
Time Frame
IUD expulsion
Time Frame: 1, 3 and 6 months after insertion
1, 3 and 6 months after insertion

Secondary Outcome Measures

Outcome Measure
Time Frame
IUD continuation
Time Frame: 1, 3 and 6 months after insertion
1, 3 and 6 months after insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Paula H Bednarek, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 21, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Estimate)

September 14, 2012

Last Update Submitted That Met QC Criteria

September 12, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OHSU FAMPLAN 2535

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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