Early vs. Interval Postpartum IUD Insertion

NCT03462758 | Completed Results DMC FDA Device

• 1 other identifier: 172101
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 4

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.

Conditions

Contraception

Keywords

Mirena; ParaGard; Skyla; Liletta; Kyleena; Intrauterine Device; Intrauterine System; Postpartum; Expulsion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Proportion of Participants Using an IUD at 6 Months

  6 months postpartum

• Proportion of Participants With an IUD Expulsion (Partial) at 6 Months

  6 months

• Proportion of Participants With a Pelvic Infection Within 6 Months

  6 months

• Patient Satisfaction With IUD Assessed on a Five-point "Likert" Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement

  6 months

• Proportion of Participants With an IUD Perforation at 6 Months

  6 months

Study Arms (2)

Control Group

OTHER

IUD placed 6-8 weeks postpartum (standard of care, interval placement)

Device: IUD

Intervention Group

EXPERIMENTAL

IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)

Device: IUD

Interventions

IUD DEVICE

Postpartum IUD placement

Also known as: Mirena, Kyleena, Skyla, Liletta, ParaGard

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• th 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

Sponsors & Collaborators

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

Study Sites (4)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (2)

• Berkley HH, Lutgendorf MA, Kully G, Raiciulescu S, Stortz SK, Hinz E, Hofler LG, Averbach S. Pain With Early Postpartum Intrauterine Device Placement. O G Open. 2025 Jun 12;2(3):e088. doi: 10.1097/og9.0000000000000088. eCollection 2025 Jun.

  PMID: 41000085 DERIVED

• Averbach S, Kully G, Hinz E, Dey A, Berkley H, Hildebrand M, Vaida F, Haider S, Hofler LG. Early vs Interval Postpartum Intrauterine Device Placement: A Randomized Clinical Trial. JAMA. 2023 Mar 21;329(11):910-917. doi: 10.1001/jama.2023.1936.

  PMID: 36943214 DERIVED

Results Point of Contact

• Title: Dr. Sarah Averbach, MD, MAS
• Organization: University of California, San Diego

familyplanningresearch@health.ucsd.edu

858-329-4464

Study Officials

• Sarah Averbach, MD, MAS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: March 13, 2018
• Study Start: March 20, 2018
• Primary Completion: August 14, 2022
• Study Completion: December 31, 2022
• Last Updated: April 13, 2023
• Results First Posted: April 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)