Postpartum Contraception
Conditions
Brief summary
This will be a randomized clinical trial of 190 women aged 18-45 who plan to breastfeed their infant for at least 6 months and desire to use the LNG-IUS as their primary contraceptive method postpartum. The investigators will compare the frequency of breastfeeding among women receiving the levonorgestrel-releasing intrauterine system (LNG-IUS) immediately after vaginal delivery compared to 4-8 weeks later. The investigators hypothesize there will be no difference in breastfeeding prevalence between the two groups.
Interventions
Placement within 48 hours of delivery
Sponsors
Society of Family Planning
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Women ages 18-45 2. Pregnant and equal to or more than 24 weeks of estimated gestational age 3. States an intent to breastfeed for at least 6 months 4. States a plan to use the LNG-IUS postpartum 5. Anticipates a vaginal delivery 6. HIV negative 7. Intend to stay in the Chapel Hill area for at least 6 months after birth 8. No medical or personal conditions which in the judgment of study staff preclude participation in the study 9. Have no allergies to any component of the LNG-IUS 10. No known uterine anomalies 11. Fluent in English 12. No history of ectopic pregnancy 13. No known or suspected carcinoma of the breast 14. No known acute liver disease or liver tumor (benign or malignant) 15. No known or suspected uterine or cervical neoplasia or unresolved abnormal pap smear 16. No active pelvic inflammatory disease 17. No known hypersensitivity to any component of the LNG-IUS 18. No genital bleeding of unknown etiology 19. No history of solid organ transplantation Additional eligibility criteria for entry into the randomized trial, as assessed postpartum 1. No endometritis or chorioamnionitis 2. Membranes ruptured for less than 24 hours prior to delivery (O'Hanley, Hayes) 3. No fever greater than or equal to 38°C during the intrapartum or postpartum period 4. Did not receive medications other than pitocin and/or misoprostol to control postpartum bleeding 5. Did not have a documented estimated blood loss of greater than 750mL intrapartum 6. Did not receive a blood transfusion for a diagnosis of postpartum hemorrhage 7. Did not have a third or fourth degree laceration at delivery. 8. The infant must be greater than 35 weeks EGA at birth as determined by physical exam at birth 9. The infant must weigh at least 2727 grams 10. Must have been a singleton birth 11. Infant not in the intensive care nursery 12. The infant has not been diagnosed with a condition which would preclude long term feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breastfeeding | 6 months | Reported any breastfeeding at the final 6 month visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LNG-IUS Expulsion or Removal | up to 6 months | Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study |
Countries
United States
Participant flow
Pre-assignment details
26 women failed entry criteria after delivery. Therefore although 61 were enrolled in the original study cohort, only 35 were randomized and allocated to one of the two treatment arms.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Placement within 48 hours of delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery | 17 |
| Control Placement 4-8 weeks after delivery
Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery | 18 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 5 |
Baseline characteristics
| Characteristic | Immediate | Control | Total |
|---|---|---|---|
| Age, Continuous | 28 years | 27 years | 27 years |
| Race/Ethnicity, Customized Black, non-Hispanic | 5 participants | 2 participants | 7 participants |
| Race/Ethnicity, Customized Hispanic or Latina | 3 participants | 5 participants | 8 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White, non-Hispanic | 8 participants | 10 participants | 18 participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 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 | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 |
Outcome results
Primary
Breastfeeding
Reported any breastfeeding at the final 6 month visit
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate | Breastfeeding | 10 participants |
| Control | Breastfeeding | 9 participants |
Secondary
LNG-IUS Expulsion or Removal
Expulsion or indicated removal of the originally placed LNG-IUS at any point during the study
Time frame: up to 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate | LNG-IUS Expulsion or Removal | 8 participants |
| Control | LNG-IUS Expulsion or Removal | 0 participants |