Contraception
Conditions
Keywords
Mirena, ParaGard, Skyla, Liletta, Kyleena, Intrauterine Device, Intrauterine System, Postpartum, Expulsion
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.
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.
Interventions
DEVICEIUD
Postpartum IUD placement
Sponsors
University of New Mexico
United States Naval Medical Center, San Diego
University of Illinois at Chicago
University of Chicago
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With an IUD Expulsion (Complete) at 6 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Using an IUD at 6 Months | 6 months postpartum | 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 |
| Proportion of Participants With an IUD Expulsion (Partial) at 6 Months | 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. |
| Proportion of Participants With a Pelvic Infection Within 6 Months | 6 months | Pelvic infection requiring antibiotics will be ascertained by patient report and/or medical record review. |
| Patient Satisfaction With IUD Assessed on a Five-point Likert Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement | 6 months | 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. |
| Proportion of Participants With an IUD Perforation at 6 Months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
404 patients enrolled in the study, all of whom met inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Interval Postpartum IUD Placement IUD placed 6-8 weeks postpartum (standard of care, interval placement)
IUD: Postpartum IUD placement | 201 |
| Early Postpartum IUD Placement IUD placed 2-4 weeks postpartum (early postpartum placement, EPP)
IUD: Postpartum IUD placement | 203 |
| Total | 404 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Chose no or other method of contraception | 20 | 23 |
| Overall Study | Lost to follow-up after IUD placement | 17 | 14 |
| Overall Study | Lost to follow-up before IUD placement | 14 | 12 |
| Overall Study | Medical contraindication | 2 | 2 |
| Overall Study | Unsuccessful IUD placement attempt | 3 | 3 |
Baseline characteristics
| Characteristic | Early Postpartum IUD Placement | Interval Postpartum IUD Placement | Total |
|---|---|---|---|
| Age, Continuous | 29.8 years STANDARD_DEVIATION 5.2 | 30.0 years STANDARD_DEVIATION 5.5 | 29.9 years STANDARD_DEVIATION 5.4 |
| Clinician performing IUD insertion Advanced practice clinician | 51 Participants | 50 Participants | 101 Participants |
| Clinician performing IUD insertion Faculty physician | 93 Participants | 75 Participants | 168 Participants |
| Clinician performing IUD insertion Resident physician | 18 Participants | 32 Participants | 50 Participants |
| Education College degree | 43 Participants | 38 Participants | 81 Participants |
| Education Graduate degree | 49 Participants | 41 Participants | 90 Participants |
| Education High school degree or less | 111 Participants | 122 Participants | 233 Participants |
| Employment Full time | 100 Participants | 92 Participants | 192 Participants |
| Employment Part time | 22 Participants | 24 Participants | 46 Participants |
| Employment Student | 15 Participants | 16 Participants | 31 Participants |
| Employment Unemployed/Retired | 66 Participants | 69 Participants | 135 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 82 Participants | 93 Participants | 175 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 121 Participants | 108 Participants | 229 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Lactating at time of IUD insertion No | 17 Participants | 24 Participants | 41 Participants |
| Lactating at time of IUD insertion Yes | 139 Participants | 127 Participants | 266 Participants |
| Parity Multiparous | 135 Participants | 130 Participants | 265 Participants |
| Parity Primiparous | 68 Participants | 71 Participants | 139 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 3 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 12 Participants | 22 Participants |
| Race (NIH/OMB) Black or African American | 26 Participants | 20 Participants | 46 Participants |
| Race (NIH/OMB) More than one race | 42 Participants | 48 Participants | 90 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 114 Participants | 114 Participants | 228 Participants |
| Sex: Female, Male Female | 203 Participants | 201 Participants | 404 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of IUD 19.5-mg/13.5-mg levonorgestrel | 6 Participants | 2 Participants | 8 Participants |
| Type of IUD 52-mg levonorgestrel | 101 Participants | 111 Participants | 212 Participants |
| Type of IUD Copper | 56 Participants | 49 Participants | 105 Participants |
| Type of most recent delivery Cesarean | 48 Participants | 49 Participants | 97 Participants |
| Type of most recent delivery Vaginal | 155 Participants | 152 Participants | 307 Participants |
| Ultrasonography used After placement only | 4 Participants | 5 Participants | 9 Participants |
| Ultrasonography used During placement | 31 Participants | 4 Participants | 35 Participants |
| Ultrasonography used None | 128 Participants | 153 Participants | 281 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 145 | 0 / 149 |
| other Total, other adverse events | 0 / 145 | 0 / 149 |
| serious Total, serious adverse events | 0 / 145 | 0 / 149 |
Outcome results
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
Time frame: 6 months postpartum
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interval Postpartum IUD Placement | Proportion of Participants With an IUD Expulsion (Complete) at 6 Months | 0 Participants |
| Early Postpartum IUD Placement | Proportion of Participants With an IUD Expulsion (Complete) at 6 Months | 3 Participants |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interval Postpartum IUD Placement | Patient Satisfaction With IUD Assessed on a Five-point Likert Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement | 116 Participants |
| Early Postpartum IUD Placement | Patient Satisfaction With IUD Assessed on a Five-point Likert Scale for Satisfaction, an Ordinal Scale That Measure Levels of Agreement/Disagreement | 129 Participants |
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
Time frame: 6 months postpartum
Population: Percentages based on total study sample rather than MITT analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interval Postpartum IUD Placement | Proportion of Participants Using an IUD at 6 Months | 139 Participants |
| Early Postpartum IUD Placement | Proportion of Participants Using an IUD at 6 Months | 141 Participants |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interval Postpartum IUD Placement | Proportion of Participants With an IUD Expulsion (Partial) at 6 Months | 11 Participants |
| Early Postpartum IUD Placement | Proportion of Participants With an IUD Expulsion (Partial) at 6 Months | 14 Participants |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interval Postpartum IUD Placement | Proportion of Participants With an IUD Perforation at 6 Months | 0 Participants |
| Early Postpartum IUD Placement | Proportion of Participants With an IUD Perforation at 6 Months | 0 Participants |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Interval Postpartum IUD Placement | Proportion of Participants With a Pelvic Infection Within 6 Months | 0 Participants |
| Early Postpartum IUD Placement | Proportion of Participants With a Pelvic Infection Within 6 Months | 3 Participants |