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Trial Outcomes & Findings for Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens (NCT NCT00433004)

NCT ID: NCT00433004

Last Updated: 2017-09-15

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

1 year

Results posted on

2017-09-15

Participant Flow

Participant milestones

Participant milestones
Measure
No Advance EC
No advance supply of emergency contraception
Advance EC Given
Advance supply of emergency contraception is given Plan B (Levonorgestrel): 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.
Overall Study
STARTED
27
23
Overall Study
COMPLETED
22
16
Overall Study
NOT COMPLETED
5
7

Reasons for withdrawal

Reasons for withdrawal
Measure
No Advance EC
No advance supply of emergency contraception
Advance EC Given
Advance supply of emergency contraception is given Plan B (Levonorgestrel): 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.
Overall Study
Lost to Follow-up
5
7

Baseline Characteristics

Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
No Advance EC
n=27 Participants
No advance supply of emergency contraception
Advance EC Given
n=23 Participants
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.
Total
n=50 Participants
Total of all reporting groups
Age, Continuous
17.6 years
n=5 Participants
17.6 years
n=7 Participants
17.6 years
n=5 Participants
Sex: Female, Male
Female
27 Participants
n=5 Participants
23 Participants
n=7 Participants
50 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure
No Advance EC
n=27 Participants
No advance supply of emergency contraception
Advance EC Given
n=23 Participants
Advance supply of emergency contraception is given Plan B (Levonorgestrel): 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.
ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.
22 Participants
16 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure
No Advance EC
n=27 Participants
No advance supply of emergency contraception
Advance EC Given
n=23 Participants
Advance supply of emergency contraception is given Plan B (Levonorgestrel): 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.
PREGNANCY RATES
8 Participants
3 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure
No Advance EC
n=27 Participants
No advance supply of emergency contraception
Advance EC Given
n=23 Participants
Advance supply of emergency contraception is given Plan B (Levonorgestrel): 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.
PLAN B USE
8 Participants
12 Participants

Adverse Events

No Advance EC

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Advance EC Given

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arden McAllister

University of Pennsylvania

Phone: 215-662-3532

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place