Post Partum
Conditions
Keywords
Teen, Plan B, Post Partum, Emergency Contraception
Brief summary
This is a pilot randomized controlled trial to assess the effects of advanced supply of emergency contraception versus routine care in a teen postpartum population. The goals are to assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.
Interventions
PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female 2. English speaking 3. Aged 14-19 at enrollment 4. Immediately postpartum of a live infant 5. Planning to parent the baby 6. Desiring to delay another pregnancy for at least one year 7. General good health 8. Willing and able to follow the study protocol
Exclusion criteria
1. Allergy to levonorgestrel 2. Current substance abuse 3. Plans for relocation outside of Philadelphia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. | 1 year |
| PREGNANCY RATES | 1 year |
| PLAN B USE | 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Advance EC No advance supply of emergency contraception | 27 |
| Advance EC Given Advance supply of emergency contraception is given
Plan B (Levonorgestrel): Postpartum TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRAPCETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS. | 23 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 7 |
Baseline characteristics
| Characteristic | No Advance EC | Advance EC Given | Total |
|---|---|---|---|
| Age, Continuous | 17.6 years | 17.6 years | 17.6 years |
| Sex: Female, Male Female | 27 Participants | 23 Participants | 50 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 | 0 / 27 | 0 / 23 |
| other Total, other adverse events | 0 / 27 | 0 / 23 |
| serious Total, serious adverse events | 0 / 27 | 0 / 23 |
Outcome results
Primary
ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Advance EC | ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. | 22 Participants |
| Advance EC Given | ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. | 16 Participants |
Primary
PLAN B USE
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Advance EC | PLAN B USE | 8 Participants |
| Advance EC Given | PLAN B USE | 12 Participants |
Primary
PREGNANCY RATES
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Advance EC | PREGNANCY RATES | 8 Participants |
| Advance EC Given | PREGNANCY RATES | 3 Participants |