Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study

Sponsor
University of Colorado, Denver (Other)
Overall Status
Completed
CT.gov ID
NCT02067663
Collaborator
Society of Family Planning (Other)
123
1
17
7.2

Study Details

Study Description

Brief Summary

The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate postpartum setting offers many advantages and is considered safe, but the risk of expulsion appears to be higher than with interval insertion. Previous studies have shown the rate of expulsion of the copper IUD in the postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While studies related to the copper IUD use ring forceps or the operator's hand for placement of the IUD, the only published study investigating immediate postplacental levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore ask the question, is there a difference in expulsion rates between levonorgestrel and copper IUDs placed post-placentally when all providers undergo a standardized training, use a standardized insertion technique, and when patient level characteristics are controlled by randomization?

The investigators propose to perform a prospective cohort trial comparing the rates of expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the uterus within 10 minutes of the delivery of the placenta, using a standardized technique (placement with a ring forceps or the operator's hand) after all providers undergo a formal didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has a higher rate of expulsion as compared to the copper IUD. Additional objectives include a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the investigators will document the natural history of the location of the IUD within the uterus when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks, and 3 months postpartum, to better understand the relationship between position of the IUD and subsequent expulsion.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
123 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Mirena Group

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Drug: Mirena
The IUD will be placed as part of standard clinical care.
Other Names:
  • LNG-IUS, IUD
  • Paragard Group

    Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

    Device: Paragard
    The IUD will be placed as part of standard clinical care.
    Other Names:
  • T380A IUD
  • Outcome Measures

    Primary Outcome Measures

    1. IUD Expulsion Rate [3 months postpartum]

      The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.

    Secondary Outcome Measures

    1. Pregnancy [6 weeks]

      A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.

    2. Pregnancy [3 months]

      A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.

    3. Complications [3 months]

      A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported.

    4. Satisfaction [3 months]

      A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of >= 8 are reported by percent of participants.

    5. Intrauterine Device Expulsion (Day 1) [Day 1]

      Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound.

    6. Intrauterine Device Expulsion (6 Weeks) [6 weeks]

      Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound.

    7. Intrauterine Device Expulsion by 12 Weeks Postpartum [12 weeks]

      Position of the IUD within the uterus will be documented by ultrasound.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Women age ≥ 18

    • Desire for immediate postpartum IUD or postpartum day #1 after a postplacental IUD placement

    • English or Spanish speaking

    • Willing to attend 2 follow-up visits

    Exclusion Criteria:
    • Multiple gestations

    • Delivery prior to 35 weeks gestational age

    • Allergy or sensitivity to any component of either IUD (including polyethylene, levonorgestrel or copper)

    • Cesarean delivery

    • Postpartum hemorrhage (estimated blood loss > 500 mL)

    • Chorioamnionitis

    • Abnormal uterine anatomy (including uterine anomaly or large fibroids)

    • Treated for Chlamydia or Gonorrhea during pregnancy without a subsequent negative follow-up test

    • Current cervical cancer or carcinoma in situ

    • Current breast cancer

    • Wilson's disease

    • If enrolling postpartum after IUD has already been placed, women will be excluded if the provider used an insertion technique other than using the ring forceps or the operator's hand

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Colorado Denver Aurora Colorado United States 80045

    Sponsors and Collaborators

    • University of Colorado, Denver
    • Society of Family Planning

    Investigators

    • Principal Investigator: Stephanie Teal, MD, University of Colorado, Denver

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT02067663
    Other Study ID Numbers:
    • 13-3264
    First Posted:
    Feb 20, 2014
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jun 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University of Colorado, Denver
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details This prospective cohort trial was conducted at 2 affiliated teaching hospitals: University of Colorado Hospital (UCH) in Aurora, CO, and Denver Health Medical Center (DHMC) in Denver, CO.
    Pre-assignment Detail
    Arm/Group Title Mirena Group Paragard Group
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care.
    Period Title: Overall Study
    STARTED 68 55
    COMPLETED 55 41
    NOT COMPLETED 13 14

    Baseline Characteristics

    Arm/Group Title Mirena Group Paragard Group Total
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care. Total of all reporting groups
    Overall Participants 68 55 123
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    26.2
    (5.3)
    27.4
    (5.4)
    26.72
    (5.35)
    Sex: Female, Male (Count of Participants)
    Female
    68
    100%
    55
    100%
    123
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    26
    38.2%
    36
    65.5%
    62
    50.4%
    Not Hispanic or Latino
    42
    61.8%
    19
    34.5%
    61
    49.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    19
    27.9%
    9
    16.4%
    28
    22.8%
    White
    38
    55.9%
    36
    65.5%
    74
    60.2%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    11
    16.2%
    10
    18.2%
    21
    17.1%
    Region of Enrollment (participants) [Number]
    United States
    68
    100%
    55
    100%
    123
    100%

    Outcome Measures

    1. Primary Outcome
    Title IUD Expulsion Rate
    Description The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.
    Time Frame 3 months postpartum

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mirena Group Paragard Group
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care.
    Measure Participants 55 41
    Count of Participants [Participants]
    20
    29.4%
    7
    12.7%
    2. Secondary Outcome
    Title Pregnancy
    Description A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.
    Time Frame 6 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mirena Group Paragard Group
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care.
    Measure Participants 56 45
    Count of Participants [Participants]
    0
    0%
    0
    0%
    3. Secondary Outcome
    Title Pregnancy
    Description A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mirena Group Paragard Group
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care.
    Measure Participants 56 45
    Count of Participants [Participants]
    0
    0%
    0
    0%
    4. Secondary Outcome
    Title Complications
    Description A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mirena Group Paragard Group
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care.
    Measure Participants 55 41
    Count of Participants [Participants]
    0
    0%
    0
    0%
    5. Secondary Outcome
    Title Satisfaction
    Description A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of >= 8 are reported by percent of participants.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mirena Group Paragard Group
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care.
    Measure Participants 35 34
    Number [percent of participants]
    91.4
    134.4%
    94.2
    171.3%
    6. Secondary Outcome
    Title Intrauterine Device Expulsion (Day 1)
    Description Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound.
    Time Frame Day 1

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mirena Group Paragard Group
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care.
    Measure Participants 56 45
    Number [participants]
    0
    0%
    0
    0%
    7. Secondary Outcome
    Title Intrauterine Device Expulsion (6 Weeks)
    Description Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound.
    Time Frame 6 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mirena Group Paragard Group
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care.
    Measure Participants 56 45
    Number [participants]
    18
    26.5%
    6
    10.9%
    8. Secondary Outcome
    Title Intrauterine Device Expulsion by 12 Weeks Postpartum
    Description Position of the IUD within the uterus will be documented by ultrasound.
    Time Frame 12 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mirena Group Paragard Group
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care.
    Measure Participants 55 41
    Count of Participants [Participants]
    21
    30.9%
    8
    14.5%

    Adverse Events

    Time Frame Adverse event information was collected from the time of consent until completion of participation (12 weeks).
    Adverse Event Reporting Description
    Arm/Group Title Mirena Group Paragard Group
    Arm/Group Description Women who have a postplacental Mirena IUD placed. (LNG-IUS) Mirena: The IUD will be placed as part of standard clinical care. Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A) Paragard: The IUD will be placed as part of standard clinical care.
    All Cause Mortality
    Mirena Group Paragard Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Mirena Group Paragard Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/68 (0%) 0/55 (0%)
    Other (Not Including Serious) Adverse Events
    Mirena Group Paragard Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/68 (0%) 0/55 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Lisa Goldthwaite
    Organization Stanford University School of Medicine
    Phone 541-515-1825
    Email lgoldthw@stanford.edu
    Responsible Party:
    University of Colorado, Denver
    ClinicalTrials.gov Identifier:
    NCT02067663
    Other Study ID Numbers:
    • 13-3264
    First Posted:
    Feb 20, 2014
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jun 1, 2019