Early vs. Interval Postpartum IUD Insertion (EPPIUD)

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Device: IUD

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 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.

• Study Type: Interventional
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego
    • San Diego, California, United States, 92134
      • Naval Medical Center San Diego
  • Illinois
    • Chicago, Illinois, United States, 60607
      • University of Illinois at Chicago
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group; IUD placed 6-8 weeks postpartum (standard of care, interval placement)	Device: IUD; Postpartum IUD placement; Other Names: Mirena, Kyleena, Skyla, Liletta, ParaGard
Experimental: Intervention Group; IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)	Device: IUD; Postpartum IUD placement; Other Names: Mirena, Kyleena, Skyla, Liletta, ParaGard

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With an IUD Expulsion (Complete) at 6 Months	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	6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Using an IUD at 6 Months	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	6 months postpartum
Proportion of Participants With an IUD Expulsion (Partial) at 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.	6 months
Proportion of Participants With a Pelvic Infection Within 6 Months	Pelvic infection requiring antibiotics will be ascertained by patient report and/or medical record review.	6 months
Patient Satisfaction With IUD Assessed on a Five-point "Likert" Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement	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.	6 months
Proportion of Participants With an IUD Perforation at 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.	6 months

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: University of Chicago; University of Illinois at Chicago; United States Naval Medical Center, San Diego; University of New Mexico

Publications and helpful links

General Publications

• Harsini S, Wilson D, Saprunoff H, Allan H, Gleave M, Goldenberg L, Chi KN, Kim-Sing C, Tyldesley S, Benard F. Outcome of patients with biochemical recurrence of prostate cancer after PSMA PET/CT-directed radiotherapy or surgery without systemic therapy. Cancer Imaging. 2023 Mar 17;23(1):27. doi: 10.1186/s40644-023-00543-0.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): August 14, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Postpartum; Intrauterine Device; Mirena; Intrauterine System; ParaGard; Skyla; Liletta; Kyleena; Expulsion
• Other Study ID Numbers: 172101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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