Contraception
Conditions
Brief summary
This a randomized control trial to identify if patients who desire LARC are more likely to have success receiving the desired form of contraception if it is placed a) during the postpartum hospital stay, either in the immediate or early postpartum period, versus b) during the interval postpartum period as previously done.
Detailed description
Randomized control trial with control group receiving LARC at 6 weeks postpartum and the study group receiving LARC in the immediate or early postpartum period. Outcomes will be measured by those who receive or do not receive LARC either in the hospital after delivery versus 6 weeks postpartum in accordance with the study subjects' randomized designation. Secondary outcomes of bleeding profile and satisfaction will also be assessed.
Interventions
DEVICELevonorgestrel IUD, copper IUD, etonorgestrel implant
Long-acting reversible contraception
Sponsors
Tulane University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant, desires LARC postpartum
Exclusion criteria
* Medical contraindication to desired LARC, vaginal delivery complicated by fourth degree perineal laceration, history of pelvic inflammatory disease, uterine infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Women With Placement of LARC | 6 months | The outcome will be measured by the number of participants with LARC placement. The total number of women who expressed a desire to have postpartum contraception placed and randomized to the appropriate arm will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With Method of LARC Using LARC Survey | 6 Weeks, 12 weeks postpartum, 6 months postpartum | Number of patients satisfied with LARC obtained by LARC survey at 6-weeks, 12-weeks postpartum, and 6 months postpartum. Patients identify Yes/No response via telephone survey asking, Are you satisfied with this form of contraception?. Satisfaction determined if subject answers Yes. A single value was calculated at the end of the study by summation at all three time points. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate or Early Placement Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception | 25 |
| Interval Placement Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant
Levonorgestrel IUD, copper IUD, etonorgestrel implant: Long-acting reversible contraception | 20 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 15 |
Baseline characteristics
| Characteristic | Immediate or Early Placement | Interval Placement | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 19 Participants | 42 Participants |
| Patients Presenting to the Office or Hospital | 25 Participants | 20 Participants | 45 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 25 participants | 20 participants | 45 participants |
| Sex: Female, Male Female | 25 Participants | 20 Participants | 45 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 / 25 | 0 / 20 |
| serious Total, serious adverse events | 0 / 25 | 0 / 20 |
Outcome results
Primary
Number of Women With Placement of LARC
The outcome will be measured by the number of participants with LARC placement. The total number of women who expressed a desire to have postpartum contraception placed and randomized to the appropriate arm will be assessed.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate or Early Placement | Number of Women With Placement of LARC | 10 Participants |
| Interval Placement | Number of Women With Placement of LARC | 2 Participants |
Secondary
Patient Satisfaction With Method of LARC Using LARC Survey
Number of patients satisfied with LARC obtained by LARC survey at 6-weeks, 12-weeks postpartum, and 6 months postpartum. Patients identify Yes/No response via telephone survey asking, Are you satisfied with this form of contraception?. Satisfaction determined if subject answers Yes. A single value was calculated at the end of the study by summation at all three time points.
Time frame: 6 Weeks, 12 weeks postpartum, 6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate or Early Placement | Patient Satisfaction With Method of LARC Using LARC Survey | 10 Participants |
| Interval Placement | Patient Satisfaction With Method of LARC Using LARC Survey | 2 Participants |