ContraceptionEPPIUDNCT03462758
Early vs. Interval Postpartum IUD Insertion
A study testing IUD in people with Contraception, run by University of California, San Diego at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- IUD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Mar 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of New Mexico
Albuquerque, New Mexico, 87131
University of Illinois at Chicago
Chicago, Illinois, 60607
University of California, San Diego
La Jolla, California, 92093
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: 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.
Read the 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.
- Conditions
- Contraception
- Being tested
- IUD
- Keywords
- Mirena, ParaGard, Skyla, Liletta, Kyleena, Intrauterine Device, Intrauterine System, Postpartum, Expulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUDDevice
Also called Mirena, Kyleena, Skyla, Liletta, ParaGard
Postpartum IUD placement
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | IUD placed 6-8 weeks postpartum (standard of care, interval placement) Receives: Device: IUD |
| Intervention Group | Experimental | IUD placed 2-4 weeks postpartum (early postpartum placement, EPP) Receives: Device: IUD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months postpartum
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start20 Mar 2018
- Primary completion14 Aug 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- University of New Mexico, United States Naval Medical Center, San Diego, University of Illinois at Chicago, University of Chicago
- Responsible party
- Principal investigator, Sarah Averbach, MD MAS, University of California, San Diego
- Investigators
- Sarah Averbach, MD, MAS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462758
- Sponsor's protocol ID
- 172101
- Acronym
- EPPIUD
- Status last verified
- Mar 2023
- First submitted
- 24 Jan 2018
- Last updated
- 13 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 41000085Averbach 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.
PubMed 36943214
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early vs. Interval Postpartum IUD Insertion: A Multi-site Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03462758
- Acronym / sponsor ID
- EPPIUD / 172101
- Conditions
- Contraception
- Keywords
- Mirena, ParaGard, Skyla, Liletta, Kyleena, Intrauterine Device, Intrauterine System, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- University of New Mexico, United States Naval Medical Center, San Diego, University of Illinois at Chicago, University of Chicago
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Posted 13 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Device: IUDIUD placed 6-8 weeks postpartum (standard of care, interval placement) |
| Intervention Group | Experimental | Device: IUDIUD placed 2-4 weeks postpartum (early postpartum placement, EPP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IUDAlso: Mirena, Kyleena, Skyla, Liletta, ParaGardPostpartum IUD placement | Device | Control Group, Intervention Group |
Primary outcome
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
5 secondary outcomes
Proportion of Participants Using an IUD at 6 Months
Time frame: 6 months postpartum
Proportion of Participants With an IUD Expulsion (Partial) at 6 Months
Time frame: 6 months
Proportion of Participants With a Pelvic Infection Within 6 Months
Time frame: 6 months
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
Proportion of Participants With an IUD Perforation at 6 Months
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41000085Berkley 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.
- Derived from this study: PubMed 36943214Averbach 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Averbach, MD, MAS principal investigator
University of California, San Diego
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUD in people with Contraception, run by University of California, San Diego at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With an IUD Expulsion (Complete) at 6 Months (time frame: 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03462758, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.