Contraception
Conditions
Keywords
Postpartum, Contraception, Intrauterine device, Intrauterine system, Mirena, Paragard, Uterine involution
Brief summary
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
Detailed description
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.
Interventions
20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
Sponsors
Society of Family Planning
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * 18 years or older * Voluntarily requesting either copper T380A or levonorgestrel IUD placement for postpartum contraception * Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the time of enrollment * English or Spanish speaking * Able to give consent and agree to terms of the study * No contraindications to use of either intrauterine device
Exclusion criteria
* Preterm delivery prior to 32 weeks gestation * Recent pregnancy with multiple gestation * Current incarceration * Known congenital or acquired uterine anomaly, including fibroids that distort the uterine cavity * Current or recent pelvic infection (chorioamnionitis treated for fever in labor only is not an exclusion) * Suspected hypersensitivity or contraindication to the chosen IUD * No insurance coverage for postpartum care, including Citizen Alien Waived Emergent Medical (CAWEM)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjects With an IUD at 3 Months Postpartum | Three months after delivery | 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) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With the Timing of IUD Placement. | Immediately following 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. |
| Uterine Thickness at the Fundus | At IUD placement | 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 With an IUD at 6 Months Postpartum | Six months after delivery | 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. |
| Number of Subjects With Adverse Events | Six months after delivery | 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. |
| Pain With IUD Placement | At the time of 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 100 |
| Levonorgestrel IUS 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 | 97 |
| Total | 197 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 3 |
Baseline characteristics
| Characteristic | Levonorgestrel IUS Insertion at 3 Weeks | Total | Levonorgestrel IUS Insertion at 6 Weeks |
|---|---|---|---|
| Age, Continuous | 27.8 years STANDARD_DEVIATION 5.7 | 28.6 years STANDARD_DEVIATION 6.4 | 29.0 years STANDARD_DEVIATION 5.8 |
| Delivery type Cesarean | 25 Participants | 51 Participants | 26 Participants |
| Delivery type Vaginal | 75 Participants | 146 Participants | 71 Participants |
| Education High school/GED or less | 31 Participants | 54 Participants | 23 Participants |
| Education More than high school | 69 Participants | 143 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 27 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 86 Participants | 170 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Insurance type Private insurance | 52 Participants | 102 Participants | 50 Participants |
| Insurance type Public insurance | 48 Participants | 95 Participants | 47 Participants |
| Planned pregnancy Planned | 51 Participants | 100 Participants | 49 Participants |
| Planned pregnancy Unplanned | 49 Participants | 97 Participants | 48 Participants |
| Sex: Female, Male Female | 100 Participants | 197 Participants | 97 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Snyder Hope Scale Agency subscale score | 23.8 units on a scale STANDARD_DEVIATION 3 | 23.4 units on a scale STANDARD_DEVIATION 3.6 | 22.9 units on a scale STANDARD_DEVIATION 4.1 |
| Snyder Hope Scale Future Scale total score | 47.2 units on a scale STANDARD_DEVIATION 5.4 | 46.5 units on a scale STANDARD_DEVIATION 6.1 | 45.9 units on a scale STANDARD_DEVIATION 6.7 |
| Snyder Hope Scale Pathway subscale score | 23.4 units on a scale STANDARD_DEVIATION 3.2 | 23.1 units on a scale STANDARD_DEVIATION 3.5 | 22.8 units on a scale STANDARD_DEVIATION 3.8 |
| Social-Support Scale Family subscale score | 22.0 units on a scale STANDARD_DEVIATION 3.6 | 21.2 units on a scale STANDARD_DEVIATION 4.7 | 20.4 units on a scale STANDARD_DEVIATION 5.6 |
| Social-Support Scale Friends subscale score | 21.3 units on a scale STANDARD_DEVIATION 4.2 | 20.9 units on a scale STANDARD_DEVIATION 4.7 | 20.5 units on a scale STANDARD_DEVIATION 5.2 |
| Social-Support Scale MDSS total score | 65.8 units on a scale STANDARD_DEVIATION 9 | 64.7 units on a scale STANDARD_DEVIATION 9.8 | 63.5 units on a scale STANDARD_DEVIATION 10.7 |
| Social-Support Scale Significant other subscale score | 23.0 units on a scale STANDARD_DEVIATION 2 | 22.7 units on a scale STANDARD_DEVIATION 2.7 | 22.4 units on a scale STANDARD_DEVIATION 3.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 100 | 0 / 97 |
| serious Total, serious adverse events | 0 / 100 | 0 / 97 |
Outcome results
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) .
Time frame: Three months after delivery
Population: Data analyzed as intent to treat regardless of when they had their IUD placed. This is IUD placed by 3 months in each group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IUD Insertion at 3 Weeks | Subjects With an IUD at 3 Months Postpartum | 66 Participants |
| IUD Insertion at 6 Weeks | Subjects With an IUD at 3 Months Postpartum | 73 Participants |
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.
Time frame: Six months after delivery
Population: All subjects analyzed. This includes all subjects enrolled on protocol and allocated. There were no adverse events in the subjects excluded after allocation.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IUD Insertion at 3 Weeks | Number of Subjects With Adverse Events | IUD perforation | 0 Participants |
| IUD Insertion at 3 Weeks | Number of Subjects With Adverse Events | Infection with IUD in place | 0 Participants |
| IUD Insertion at 3 Weeks | Number of Subjects With Adverse Events | Pregnancy with IUD in place | 0 Participants |
| IUD Insertion at 3 Weeks | Number of Subjects With Adverse Events | No known adverse events | 98 Participants |
| IUD Insertion at 3 Weeks | Number of Subjects With Adverse Events | IUD expulsion | 2 Participants |
| IUD Insertion at 6 Weeks | Number of Subjects With Adverse Events | No known adverse events | 97 Participants |
| IUD Insertion at 6 Weeks | Number of Subjects With Adverse Events | IUD expulsion | 0 Participants |
| IUD Insertion at 6 Weeks | Number of Subjects With Adverse Events | IUD perforation | 0 Participants |
| IUD Insertion at 6 Weeks | Number of Subjects With Adverse Events | Pregnancy with IUD in place | 0 Participants |
| IUD Insertion at 6 Weeks | Number of Subjects With Adverse Events | Infection with IUD in place | 0 Participants |
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.
Time frame: At the time of IUD placement.
Population: Subjects analyzed by actual timing of IUD insertion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IUD Insertion at 3 Weeks | Pain With IUD Placement | 15.7 mm | Standard Deviation 16.4 |
| IUD Insertion at 6 Weeks | Pain With IUD Placement | 23.0 mm | Standard Deviation 21 |
| 18-24 Days After Cesarean Delivery | Pain With IUD Placement | 30.9 mm | Standard Deviation 27.3 |
| 39-45 Days After Cesarean Delivery | Pain With IUD Placement | 32.1 mm | Standard Deviation 27.9 |
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.
Time frame: Immediately following IUD placement.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IUD Insertion at 3 Weeks | Satisfaction With the Timing of IUD Placement. | 90.6 mm on VAS | Standard Deviation 17.2 |
| IUD Insertion at 6 Weeks | Satisfaction With the Timing of IUD Placement. | 93.5 mm on VAS | Standard Deviation 12 |
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.
Time frame: Six months after delivery
Population: Population is subject randomization groups.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IUD Insertion at 3 Weeks | Subjects With an IUD at 6 Months Postpartum | 53 Participants |
| IUD Insertion at 6 Weeks | Subjects With an IUD at 6 Months Postpartum | 53 Participants |
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.
Time frame: At IUD placement
Population: Subjects who had their IUD placed at the allocated timing of 18-24 days versus 39-45 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IUD Insertion at 3 Weeks | Uterine Thickness at the Fundus | 2.3 cm | Standard Deviation 0.8 |
| IUD Insertion at 6 Weeks | Uterine Thickness at the Fundus | 1.7 cm | Standard Deviation 0.4 |