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Incomplete study enrollment prior to depletion of funding
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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead to negative consequences during the subsequent pregnancy. Providers have traditionally delayed starting birth control, especially placement of intrauterine devices (IUDs), post-delivery for a number of reasons. The first postpartum visit after a woman has given birth is typically scheduled for 6 weeks after her delivery, during which she is typically provided with her chosen method of birth control. This study will evaluate two different IUD placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to determine if placement time affects a woman's follow-through obtaining the IUD and keeping it inserted in place. The researchers will also look at bleeding patterns and patient/provider satisfaction with the IUD placement
The goal of this study is to investigate whether early interval placement of a postpartum IUD at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater uptake of the IUD by 3 months after delivery. Many women do not return for a follow up visit. We will investigate whether they are more likely to return and to receive an IUD if the follow up visit is earlier. Measures of 6 month IUD continuation, subject acceptability, safety and efficacy will also be examined. This prospective, randomized, controlled trial will enroll approximately 240 women at our academic tertiary care hospital in the United States. Participants will be recruited from women who deliver a live-born singleton infant at greater than 32 weeks gestation and who have indicated interest in obtaining intrauterine contraception. Subjects will choose to receive either a levonorgestrel-containing IUS (Mirena) or copper T380A IUD (ParaGard). Enrolled subjects will be randomized to IUD placement at either 3 weeks (+/- 3 days) or 6 weeks (+/- 3 days) after their delivery date. Women will be followed by phone contacts at 3 months and 4 months and will have a clinic visit with an ultrasound at 6 months after delivery. The IUD position in the uterus and the uterine size will be assessed at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levonorgestrel IUS insertion at 3 weeks | Experimental | IUD placement at 3 weeks after delivery. |
|
| Levonorgestrel IUS insertion at 6 weeks | Experimental | IUD placement at 6 weeks after delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel IUS | Drug | 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With an IUD at 3 Months Postpartum | Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) . | Three months after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With the Timing of IUD Placement. | Subjects were asked to record their overall satisfaction with the timing of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "very dissatisfied" and "very satisfied." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maureen Baldwin, MD, MPH | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29750924 | Derived | Baldwin MK, Hart KD, Rodriguez MI. Predictors for follow-up among postpartum patients enrolled in a clinical trial. Contraception. 2018 Sep;98(3):228-231. doi: 10.1016/j.contraception.2018.04.016. Epub 2018 May 8. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IUD Insertion at 3 Weeks | IUD placement at 3 weeks after delivery. Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS or Copper T intrauterine device |
| FG001 | IUD Insertion at 6 Weeks | IUD placement at 6 weeks after delivery. Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS or Copper T intrauterine device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Levonorgestrel IUS Insertion at 3 Weeks | IUD placement at 3 weeks after delivery. Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device |
| BG001 | Levonorgestrel IUS Insertion at 6 Weeks |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Subjects With an IUD at 3 Months Postpartum | Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) . | Data analyzed as intent to treat regardless of when they had their IUD placed. This is IUD placed by 3 months in each group. | Posted | Count of Participants | Participants | Three months after delivery |
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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 | IUD Insertion at 3 Weeks | IUD placement at 3 weeks after delivery. Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IUD expulsion | Reproductive system and breast disorders | Systematic Assessment | Partial or complete expulsion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maureen Baldwin, MD MPH | Oregon Health & Science University | (503) 494-9762 | schaum@ohsu.edu |
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| Immediately following IUD placement. |
| Uterine Thickness at the Fundus | Transvaginal ultrasound will be performed immediately following IUD placement. The thickness of the uterine myometrium at the fundus from the endometrium to the outer edge of the serosa will be measured in centimeters using an ultrasound caliper in the sagittal view. | At IUD placement |
| Subjects With an IUD at 6 Months Postpartum | Subjects will return to clinic for an ultrasound and exam at six months after delivery. We will compare the proportion of subjects with an IUD at this time of those randomized to each placement timing. | Six months after delivery |
| Number of Subjects With Adverse Events | Subjects will be followed for 6 months each. Over the 6 month study period, the number and proportion of subjects who experience adverse events including treatment for infection, IUD expulsion or IUD perforation will be assessed. | Six months after delivery |
| Pain With IUD Placement | Subjects were asked to record their current pain immediate at the time of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "no pain" and "worst pain in my life." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher pain. The distance from the left side of the 10 cm line to the mark will be measured in millimeters and compared between randomization groups if they received an IUD at the allocated timing of 18-24 or 39-45 days. | At the time of IUD placement. |
IUD placement at 6 weeks after delivery. Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Insurance type | Count of Participants | Participants |
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| Planned pregnancy | Count of Participants | Participants |
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| Delivery type | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Snyder Hope Scale | The Snyder Hope Scale (Future Scale) is a 12-question validated survey that includes four questions that reflect agency, four that reflect pathways, and four that are distracters. Responses to this scale correlate well with other psychological tests designed to assess optimism, expectancy for attaining goals, and self-esteem. The distracter questions are not scored. The maximum total score is 64 (range 0-64; max 8 points per 8 questions scored and added). Each subscale has a maximum total score of 32 (range 0-32). Higher total score and subscale scores indicate better agency and pathways. | Mean | Standard Deviation | units on a scale |
|
| Social-Support Scale | The Multidimensional Scale of Perceived Social Support (MDSS) is a 12-question validated survey to assess perceived social support, another possible indicator for the ability to carry out a plan. The scores can be separated into 3 subscale domains for perceived support from family, friends, and significant other. Maximum total score is 84 (range 0-84), which included added subscale scores of maximum 28 (0-28) for 4 questions each. Higher scores indicate more perceived social support. | Mean | Standard Deviation | units on a scale |
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IUD placement at 6 weeks after delivery. Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device |
|
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| Secondary | Satisfaction With the Timing of IUD Placement. | Subjects were asked to record their overall satisfaction with the timing of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "very dissatisfied" and "very satisfied." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher satisfaction. | Includes all subjects enrolled on protocol who underwent IUD placement at a study visit at any timing prior to 3 months postpartum. Comparison is based on randomization timing but actual timing of placement may have differed. Numbers differ from primary outcome due to removals and expulsion prior to 3 months, and placement outside study visits. | Posted | Mean | Standard Deviation | mm on VAS | Immediately following IUD placement. |
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| Secondary | Uterine Thickness at the Fundus | Transvaginal ultrasound will be performed immediately following IUD placement. The thickness of the uterine myometrium at the fundus from the endometrium to the outer edge of the serosa will be measured in centimeters using an ultrasound caliper in the sagittal view. | Subjects who had their IUD placed at the allocated timing of 18-24 days versus 39-45 days | Posted | Mean | Standard Deviation | cm | At IUD placement |
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| Secondary | Subjects With an IUD at 6 Months Postpartum | Subjects will return to clinic for an ultrasound and exam at six months after delivery. We will compare the proportion of subjects with an IUD at this time of those randomized to each placement timing. | Population is subject randomization groups. | Posted | Count of Participants | Participants | Six months after delivery |
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| Secondary | Number of Subjects With Adverse Events | Subjects will be followed for 6 months each. Over the 6 month study period, the number and proportion of subjects who experience adverse events including treatment for infection, IUD expulsion or IUD perforation will be assessed. | All subjects analyzed. This includes all subjects enrolled on protocol and allocated. There were no adverse events in the subjects excluded after allocation. | Posted | Count of Participants | Participants | Six months after delivery |
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| Secondary | Pain With IUD Placement | Subjects were asked to record their current pain immediate at the time of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "no pain" and "worst pain in my life." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher pain. The distance from the left side of the 10 cm line to the mark will be measured in millimeters and compared between randomization groups if they received an IUD at the allocated timing of 18-24 or 39-45 days. | Subjects analyzed by actual timing of IUD insertion | Posted | Mean | Standard Deviation | mm | At the time of IUD placement. |
|
|
|
| 0 |
| 100 |
| 2 |
| 100 |
| EG001 | IUD Insertion at 6 Weeks | IUD placement at 6 weeks after delivery. Levonorgestrel IUS: 20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device | 0 | 97 | 0 | 97 |
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| Pregnancy with IUD in place |
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| Infection with IUD in place |
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| No known adverse events |
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