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

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ClinicalTrials.gov Identifier: NCT02067663
Recruitment Status : Completed
First Posted : February 20, 2014
Results First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date February 11, 2014
First Posted Date February 20, 2014
Results First Submitted Date May 25, 2018
Results First Posted Date July 4, 2019
Last Update Posted Date July 4, 2019
Study Start Date April 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 21, 2014)
IUD Expulsion Rate [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: February 18, 2014)
  • Expulsion of levonorgestrel intrauterine system (LNG-IUS) [ Time Frame: 1 day ]
    The primary outcome of the study will be the comparison of the proportion of participants with partial, full, or unrecognized expulsions of the LNG-IUS as compared to the copper IUD when placed within 10 minutes of the delivery of the placenta. A pelvic exam and/or transvaginal ultrasound may be done to confirm any suspected expulsion.
  • Expulsion of levonorgestrel intrauterine system (LNG-IUS) [ Time Frame: 6 weeks ]
    The primary outcome of the study will be the comparison of the proportion of participants with partial, full, or unrecognized expulsions of the LNG-IUS as compared to the copper IUD when placed within 10 minutes of the delivery of the placenta. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.
  • Expulsion of levonorgestrel intrauterine system (LNG-IUS) [ Time Frame: 3 months ]
    The primary outcome of the study will be the comparison of the proportion of participants with partial, full, or unrecognized expulsions of the LNG-IUS as compared to the copper IUD when placed within 10 minutes of the delivery of the placenta. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.
Change History Complete list of historical versions of study NCT02067663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 27, 2019)
  • Pregnancy [ Time Frame: 6 weeks ]
    A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.
  • Pregnancy [ Time Frame: 3 months ]
    A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.
  • Complications [ Time Frame: 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.
  • Satisfaction [ Time Frame: 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.
  • Intrauterine Device Expulsion (Day 1) [ Time Frame: Day 1 ]
    Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound.
  • Intrauterine Device Expulsion (6 Weeks) [ Time Frame: 6 weeks ]
    Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound.
  • Intrauterine Device Expulsion by 12 Weeks Postpartum [ Time Frame: 12 weeks ]
    Position of the IUD within the uterus will be documented by ultrasound.
Original Secondary Outcome Measures
 (submitted: February 18, 2014)
  • Complications [ Time Frame: Day 1 ]
    A questionnaire will be administered to determine if the participant has had any complications since placement.
  • Pregnancy [ Time Frame: 6 weeks ]
    A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.
  • Satisfaction [ Time Frame: Day 1 ]
    A questionnaire will be administered to determine the participant's satisfaction level with the IUD.
  • Pregnancy [ Time Frame: 3 months ]
    A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.
  • Complications [ Time Frame: 6 weeks ]
    A questionnaire will be administered to determine if the participant has had any complications since placement.
  • Complications [ Time Frame: 3 months ]
    A questionnaire will be administered to determine if the participant has had any complications since placement.
  • Satisfaction [ Time Frame: 6 weeks ]
    A questionnaire will be administered to determine the participant's satisfaction level with the IUD.
  • Satisfaction [ Time Frame: 3 months ]
    A questionnaire will be administered to determine the participant's satisfaction level with the IUD.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study
Official Title Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women interested in an immediate postpartum IUD, or those who recently had one placed, who are willing to be followed postpartum.
Condition Contraception
Intervention
  • Device: Paragard
    The IUD will be placed as part of standard clinical care.
    Other Name: T380A IUD
  • Drug: Mirena
    The IUD will be placed as part of standard clinical care.
    Other Name: LNG-IUS, IUD
Study Groups/Cohorts
  • Mirena Group
    Women who have a postplacental Mirena IUD placed. (LNG-IUS)
    Intervention: Drug: Mirena
  • Paragard Group
    Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
    Intervention: Device: Paragard
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 8, 2015)
123
Original Estimated Enrollment
 (submitted: February 18, 2014)
300
Actual Study Completion Date September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02067663
Other Study ID Numbers 13-3264
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor University of Colorado, Denver
Collaborators Society of Family Planning
Investigators
Principal Investigator: Stephanie Teal, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date June 2019