Early vs. Interval Postpartum IUD Insertion

Contraception Clinical Trial

— EPPIUD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462758
• Other study ID #: 172101
• Status: Completed
• Phase: N/A
• Start date: March 20, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: December 31, 2022
• Est. primary completion date: August 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• IUD
Postpartum IUD placement

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of California, San Diego	La Jolla	California
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Diego	United States Naval Medical Center, San Diego, University of Chicago, University of Illinois at Chicago, University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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