Contraception
Conditions
Keywords
Contraception, Birth Control, Levonorgestrel IUD, Mirena IUD
Brief summary
We are studying the effect of placing the levonorgestrel IUD (Mirena) immediately after birth on breastfeeding. Women who wish to have a levonorgestrel IUD placed after their birth, wish to breastfeed, and are willing to participate in the study will be randomly assigned to either get the IUD placed immediately after delivery of the baby and placenta or 4-6 weeks later. We do not believe there will be a difference in breastfeeding 8 weeks after delivery between those who get the IUD placed early or later.
Detailed description
Increasing use of the levonorgestrel intrauterine device (LNG IUD) has become a cornerstone of U.S. efforts to decrease our nation's high rate of unplanned pregnancy. Many women initiate use of this method in the post partum period. The major advantage of immediate postplacental LNG IUD insertion is the prompt initiation of a highly effective contraceptive method at a time that does not interfere with the intense demands of newborn care, but any contraceptive method initiated in the postpartum period must not interfere with breastfeeding. Our long-term goal is to understand the impact of hormonal contraceptives, initiated early in the postpartum period, on breastfeeding. The central hypothesis is that quality of breastfeeding is not negatively affected by progestin-only hormonal contraceptives. We will pursue three specific aims comparing women randomized to immediate post-placental vs. delayed (4-6 week) postpartum LNG IUD insertion: Aim #1: To determine breastfeeding continuation rates at 8 weeks in both groups Aim #2: To determine timing of lactogenesis in both groups Aim #3: To assess breastfeeding continuation, exclusivity, and satisfaction as well as continuation and satisfaction with the LNG IUD at 26 weeks postpartum in both groups This proposal will support a non-inferiority RCT where participants will be randomly assigned to immediate postplacental insertion (within 10 minutes of placental delivery) or delayed postpartum insertion (4-6 weeks postpartum). This project will provide needed evidence on breastfeeding impact of early postpartum initiation of the LNG IUD.
Interventions
Timing of IUD insertion
Sponsors
Society of Family Planning
University of New Mexico
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Healthy, 18-40 year old pregnant women * Intend to breastfeed * Desire the LNG IUD as their method of contraception * Agree to be randomized to early versus standard postpartum insertion * Have delivered a healthy term infant (37 weeks gestation) * Willing to complete all study related procedures, visits and questionnaires
Exclusion criteria
* Chorioamnionitis * Obstetric complications including transfusion * Severe pregnancy induced hypertension * Prolonged hospitalization * Coagulopathy * Liver disease * Undiagnosed genital bleeding, or other relative contraindication to LNG IUD insertion (known or suspected pregnancy, uterine cavity abnormality, known, suspected, or history of breast cancer, or hypersensitivity to any of the components in the LNG IUD).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding Continuation Rates at 8 Weeks Postpartum | 8 weeks postpartum | To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Lactogenesis Stage 2 | First 5 days after birth | To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Early IUD Insertion Group Immediate post-placental placement of the levonorgestrel IUD
Levonorgestrel IUD: Timing of IUD insertion | 147 |
| Standard Postpartum Insertion Group Placement of the levonorgestrel IUD 4-6 weeks postpartum
Levonorgestrel IUD: Timing of IUD insertion | 138 |
| Total | 285 |
Baseline characteristics
| Characteristic | Standard Postpartum Insertion Group | Early IUD Insertion Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 138 Participants | 147 Participants | 285 Participants |
| Age, Continuous | 28.1 Years STANDARD_DEVIATION 5.6 | 28.6 Years STANDARD_DEVIATION 5.4 | 28.4 Years STANDARD_DEVIATION 5.5 |
| Region of Enrollment United States | 138 participants | 147 participants | 285 participants |
| Sex: Female, Male Female | 138 Participants | 147 Participants | 285 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 147 | 0 / 138 |
| serious Total, serious adverse events | 1 / 147 | 0 / 138 |
Outcome results
Primary
Breastfeeding Continuation Rates at 8 Weeks Postpartum
To determine breastfeeding continuation rates at 8 weeks in women randomized to immediate post-placental vs. delayed (4-8 weeks) postpartum levonorgestrel IUD insertion.
Time frame: 8 weeks postpartum
Population: 147 Early IUD Insertion participants at baseline drops to 112 at 8 weeks due to exclusions for medical complications (n=15), inability to provide immediate IUD (n=7) and loss to follow up (n=13). In the Standard Insertion group 138 at baseline drops to 102 at 8 weeks with medical comps (n=11), failure to receive IUD (n=24), and 1 loss to follow up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Early IUD Insertion Group | Breastfeeding Continuation Rates at 8 Weeks Postpartum | 88 Participants |
| Standard Postpartum Insertion Group | Breastfeeding Continuation Rates at 8 Weeks Postpartum | 86 Participants |
Secondary
Time to Lactogenesis Stage 2
To evaluate potential delay in lactogenesis caused by immediate postpartum insertion of the LNG IUD.
Time frame: First 5 days after birth
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Early IUD Insertion Group | Time to Lactogenesis Stage 2 | 65.3 Hours | Standard Deviation 25.7 |
| Standard Postpartum Insertion Group | Time to Lactogenesis Stage 2 | 63.6 Hours | Standard Deviation 21.6 |