Early vs. Interval Postpartum IUD Insertion (EPPIUD)

• ClinicalTrials.gov Identifier: NCT03462758
• Recruitment Status: Active, not recruiting
• First Posted: March 13, 2018
• Last Update Posted: October 6, 2021
• Sponsor: University of California, San Diego
• Collaborators: University of New Mexico; United States Naval Medical Center, San Diego; University of Illinois at Chicago; University of Chicago
• Information provided by (Responsible Party): Sarah Averbach, MD MAS, University of California, San Diego

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 404 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 1, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

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

Outcome Measures

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 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.
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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, California

University of California, San Diego

La Jolla, California, United States, 92093

Naval Medical Center San Diego

San Diego, California, United States, 92134

United States, Illinois

University of Illinois at Chicago

Chicago, Illinois, United States, 60607

United States, New Mexico

University of New Mexico

Albuquerque, New Mexico, United States, 87131

Sponsors and Collaborators

University of California, San Diego

University of New Mexico

United States Naval Medical Center, San Diego

University of Illinois at Chicago

University of Chicago

Investigators

• Principal Investigator: Sarah Averbach, MD, MAS; University of California, San Diego

More Information

• Responsible Party: Sarah Averbach, MD MAS, Associate Professor, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03462758
• Other Study ID Numbers: 172101
• First Posted: March 13, 2018
• Last Update Posted: October 6, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• 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