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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

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
Contraception Device: Paragard Drug: Mirena

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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 : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Group/Cohort 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 Name: 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 Name: T380A IUD




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pregnancy [ Time Frame: 6 weeks ]
    A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.

  2. Pregnancy [ Time Frame: 3 months ]
    A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.

  3. 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.

  4. 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.

  5. 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.

  6. Intrauterine Device Expulsion (6 Weeks) [ Time Frame: 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 [ Time Frame: 12 weeks ]
    Position of the IUD within the uterus will be documented by ultrasound.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067663


Locations
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United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Society of Family Planning
Investigators
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Principal Investigator: Stephanie Teal, MD University of Colorado, Denver

Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02067663     History of Changes
Other Study ID Numbers: 13-3264
First Posted: February 20, 2014    Key Record Dates
Results First Posted: July 4, 2019
Last Update Posted: July 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Colorado, Denver:
Postplacental IUD placement
LNG-IUS
Additional relevant MeSH terms:
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Levonorgestrel
Copper
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Trace Elements
Micronutrients
Nutrients
Growth Substances