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Early vs. Interval Postpartum IUD Insertion (EPPIUD)

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ClinicalTrials.gov Identifier: NCT03462758
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
University of New Mexico
United States Naval Medical Center, San Diego
Information provided by (Responsible Party):
Sarah Averbach, MD MAS, University of California, San Diego

Brief Summary:
Intrauterine devices (IUDs) are historically placed at a six-week postpartum visit for women who desire intrauterine contraception after delivery. A two-week postpartum visit could be a convenient time for women to receive contraception, including IUDs. Offering women IUDs at two-weeks postpartum may decrease the risk of undesired pregnancy and rapid repeat pregnancy. This study will compare IUD insertion at two different times after delivery: two-weeks and six-weeks postpartum. This will allow researchers to assess whether the timing of IUD placement affects whether an IUD is expelled, or pushed out of it's ideal location.

Condition or disease Intervention/treatment Phase
Contraception Device: IUD Not Applicable

Detailed Description:

The purpose of this study is to determine the proportion of IUDs inserted in the Early Postpartum (EPP) period that are expelled at 6 months postpartum. This prospective, multi-site randomized trial will enroll approximately 424 women at three large academic hospitals in the United States.

Women will be recruited who are interested in receiving a levonorgestrel-IUD or a copper-IUD after delivery. Postpartum women who desire an IUD will be randomized to EPP IUD insertion (between 14-28 days PP) or interval postpartum IUD insertion (42-56 days PP) and the proportion of IUDs expelled will be compared between groups at 6 months postpartum. All women will be seen in clinic at 6-8 weeks and 6 months postpartum. Women randomized to EPP IUD placement will be seen at 2-3 weeks postpartum.

Provider perspectives of EPP IUD placement will also be evaluated, as will whether these attitudes change after 6 to 9 months of providing early postpartum IUDs.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Early vs. Interval Postpartum IUD Insertion: A Multi-site Randomized Controlled Trial
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Control Group
IUD placed 6-8 weeks postpartum (standard of care, interval placement)
Device: IUD
Postpartum IUD placement
Other Name: Mirena, Kyleena, Skyla, Liletta, ParaGard

Experimental: Intervention Group
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
Device: IUD
Postpartum IUD placement
Other Name: Mirena, Kyleena, Skyla, Liletta, ParaGard




Primary Outcome Measures :
  1. Proportion of participants using an IUD at 6 months [ Time Frame: 6 months postpartum ]
    IUD utilization will be defined as intrauterine use of an IUD at 6 months postpartum. A speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use


Secondary Outcome Measures :
  1. Proportion of participants with an IUD expulsion (complete) at 6 months [ Time Frame: 6 months postpartum ]
    Complete IUD expulsion will be defined as an IUD which no longer in the uterus on transvaginal ultrasound and not found in the abdomen or pelvis on x-ray. A speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum. If expulsion has occurred, the participant will have an abdominal x-ray to confirm expulsion (and rule out perforation).

  2. Proportion of participants with an IUD expulsion (partial) at 6 months [ Time Frame: 6 months ]
    Partial IUD expulsions will be diagnosed in any participant found to have an IUD in which part of the body of the IUD is noted to be coming through the external cervical os on speculum exam.

  3. Proportion of participants with a Pelvic infection within 6 months [ Time Frame: 6 months ]
    Pelvic infection requiring antibiotics will be ascertained by patient report and/or medical record review.

  4. Patient satisfaction with IUD assessed on a five-point Likert scale [ Time Frame: 6 months ]
    Participant's asked how much they agree with the statement "I am satisfied with using this IUD." Possible answers are: Strongly Agree, Agree, Neutral, Disagree, Strongly Disagree.

  5. Provider perceptions of early postpartum IUD placement [ Time Frame: 6 months ]
    Provider perceptions of early postpartum IUD placement will be ascertained by qualitative interviews with providers and by surveys of providers before and after experience with early postpartum IUD placement.

  6. Proprotion of participants with an IUD perforation at 6 months [ Time Frame: 6 months ]
    IUD perforations through the uterus will be diagnosed when an IUD visible is not visible on transvaginal ultrasound of the uterus but is visible on x-ray of the abdomen or pelvis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gave birth less than or equal to 10 days ago
  • Desires to use an IUD for Contraception (either copper or levonorgestrel)
  • Willing and able to sign an informed consent
  • Willing to comply with the study protocol
  • Age greater than or equal to 18 years
  • English or Spanish speaking

Exclusion Criteria:

  • Uterine anomaly or leiomyomata which would not allow placement of an IUD
  • Desire for repeat pregnancy in less than 6 months
  • Evidence of intrauterine infection (chorioamnionitis or postpartum endometritis) treated with antibiotics
  • Ruptured uterus at the time of delivery
  • Received a postpartum tubal ligation or immediate postpartum IUD or implant at delivery
  • Incarcerated women or women with significant cognitive impairment
  • 4th degree perineal laceration sustained at delivery
  • Any medical contraindication to IUD per the US Centers for Disease Control (CDC) Medical Eligibility Criteria
  • Suspicion for new pregnancy

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): NCT03462758


Contacts
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Contact: Marisa Hildebrand, MPH 8583294464 familyplanningresearch@ucsd.edu
Contact: Sarah Averbach, MD, MAS 8582491205 saverbach@ucsd.edu

Locations
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United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Marisa Hildebrand, MPH       familyplanningresearch@ucsd.edu   
Principal Investigator: Sarah Averbach, MD, MAS         
Naval Medical Center San Diego Not yet recruiting
San Diego, California, United States, 92134
Contact: Sharon Stortz, MD    619-807-6551    Sharon.k.stortz@mil.mail.mil   
Principal Investigator: Antoinette Marengo-Barbick, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Lisa Hofler, MD, MPH, MBA    505-205-4118    HSC-FamilyPlanningResearch@salud.unm.edu   
Principal Investigator: Lisa Hofler, MD, MPH, MBA         
Sub-Investigator: Regan Riley, DO         
Sponsors and Collaborators
University of California, San Diego
University of New Mexico
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Sarah Averbach, MD, MAS University of California, San Diego

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Responsible Party: Sarah Averbach, MD MAS, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03462758     History of Changes
Other Study ID Numbers: 172101
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Sarah Averbach, MD MAS, University of California, San Diego:
Mirena
ParaGard
Skyla
Liletta
Kyleena
Intrauterine Device
Intrauterine System
Postpartum
Expulsion