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Completed

NCT Number: NCT03462758

Early vs. Interval Postpartum IUD Insertion

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.

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Key information

Conditions

Contraception

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego, La Jolla, California, United States

Loading trial locations.

About this study

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 404 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IUD

Device

Postpartum IUD placement

Other names: Mirena, Kyleena, Skyla, Liletta, ParaGard

Primary outcomes

  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 speculum exam and transvaginal ultrasound will be performed on all patients at 6 months postpartum to confirm IUD use

Secondary outcomes

  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

  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 for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement

    Time frame: 6 months

    Participants are asked how much they agree with the statement "I am satisfied with using this IUD." Answers are valued 1-5, with 1 Strongly Agree, 2 Agree, 3 Neutral, 4 Disagree, and 5 Strongly Disagree. 1=Strongly Agree is considered the best outcome, 5=Strongly disagree is considered the worst outcome. Outcome reported is those who were very satisfied or satisfied.

  5. Proportion 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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • United States Naval Medical Center, San Diego
  • University of Chicago
  • University of Illinois at Chicago
  • University of New Mexico

Registry information

Official study title

Early vs. Interval Postpartum IUD Insertion: A Multi-site Randomized Controlled Trial

Acronym: EPPIUD

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2018
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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