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| Name | Class |
|---|---|
| University of New Mexico | OTHER |
| United States Naval Medical Center, San Diego | FED |
| University of Illinois at Chicago | OTHER |
| University of Chicago |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Other | IUD placed 6-8 weeks postpartum (standard of care, interval placement) |
|
| Intervention Group | Experimental | IUD placed 2-4 weeks postpartum (early postpartum placement, EPP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IUD | Device | Postpartum IUD placement |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Averbach, MD, MAS | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | La Jolla | California | 92093 | United States | ||
| Naval Medical Center San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41000085 | Derived | 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. | |
| 36943214 | 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. |
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404 patients enrolled in the study, all of whom met inclusion criteria.
Participants were recruited from inpatient postpartum hospital units of the study sites. The first participant was enrolled on March 26, 2018 and the final participant was enrolled on July 29, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Interval Postpartum IUD Placement | IUD placed 6-8 weeks postpartum (standard of care, interval placement) IUD: Postpartum IUD placement |
| FG001 | Early Postpartum IUD Placement | IUD placed 2-4 weeks postpartum (early postpartum placement, EPP) IUD: Postpartum IUD placement |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interval Postpartum IUD Placement | IUD placed 6-8 weeks postpartum (standard of care, interval placement) IUD: Postpartum IUD placement |
| BG001 | Early Postpartum IUD Placement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period. | Posted | Count of Participants | Participants | 6 months postpartum |
|
6 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interval Postpartum IUD Placement | IUD placed 6-8 weeks postpartum (standard of care, interval placement) IUD: Postpartum IUD placement |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarah Averbach, MD, MAS | University of California, San Diego | 858-329-4464 | familyplanningresearch@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2018 | Mar 20, 2023 | Prot_SAP_000.pdf |
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| OTHER |
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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 |
| San Diego |
| California |
| 92134 |
| United States |
| University of Illinois at Chicago | Chicago | Illinois | 60607 | United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Unsuccessful IUD placement attempt |
|
| Medical contraindication |
|
| Lost to follow-up after IUD placement |
|
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Employment | Count of Participants | Participants |
|
| Type of most recent delivery | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| Type of IUD | All participants who had an IUD placed at any time between randomization and 6-month follow-up. | Count of Participants | Participants |
|
| Ultrasonography used | All participants who had an IUD placed at any time between randomization and 6-month follow-up. | Count of Participants | Participants |
|
| Lactating at time of IUD insertion | Excluding missing values on lactation status. | Count of Participants | Participants |
|
| Clinician performing IUD insertion | Excluding missing values on clinician type. | Count of Participants | Participants |
|
IUD placed 2-4 weeks postpartum (early postpartum placement, EPP) IUD: Postpartum IUD placement |
|
|
| 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 | Percentages based on total study sample rather than MITT analysis. | Posted | Count of Participants | Participants | 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. | Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period. | Posted | Count of Participants | Participants | 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. | Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period. | Posted | Count of Participants | Participants | 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. | Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period. | Posted | Count of Participants | Participants | 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. | Modified intention to treat (MITT) analysis: those who received an IUD within 6 months of delivery whose outcome was known at the end of the study period. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 145 |
| 0 |
| 145 |
| 0 |
| 145 |
| EG001 | Early Postpartum IUD Placement | IUD placed 2-4 weeks postpartum (early postpartum placement, EPP) IUD: Postpartum IUD placement | 0 | 149 | 0 | 149 | 0 | 149 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Graduate degree |
|
| Part time |
|
| Student |
|
| 19.5-mg/13.5-mg levonorgestrel |
|
| None |
|
| Resident physician |
|