Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00433004
Recruitment Status : Completed
First Posted : February 9, 2007
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Post Partum
Intervention Drug: Plan B (Levonorgestrel)
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title No Advance EC Advance EC Given
Hide Arm/Group Description No advance supply of emergency contraception

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.

Period Title: Overall Study
Started 27 23
Completed 22 16
Not Completed 5 7
Reason Not Completed
Lost to Follow-up             5             7
Arm/Group Title No Advance EC Advance EC Given Total
Hide Arm/Group Description No advance supply of emergency contraception

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 of all reporting groups
Overall Number of Baseline Participants 27 23 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 27 participants 23 participants 50 participants
17.6
(14 to 19)
17.6
(14 to 19)
17.6
(14 to 19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 23 participants 50 participants
Female
27
 100.0%
23
 100.0%
50
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Advance EC Advance EC Given
Hide Arm/Group Description:
No advance supply of emergency contraception

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 Number of Participants Analyzed 27 23
Measure Type: Count of Participants
Unit of Measure: Participants
22
  81.5%
16
  69.6%
2.Primary Outcome
Title PREGNANCY RATES
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Advance EC Advance EC Given
Hide Arm/Group Description:
No advance supply of emergency contraception

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 Number of Participants Analyzed 27 23
Measure Type: Count of Participants
Unit of Measure: Participants
8
  29.6%
3
  13.0%
3.Primary Outcome
Title PLAN B USE
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No Advance EC Advance EC Given
Hide Arm/Group Description:
No advance supply of emergency contraception

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 Number of Participants Analyzed 27 23
Measure Type: Count of Participants
Unit of Measure: Participants
8
  29.6%
12
  52.2%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No Advance EC Advance EC Given
Hide Arm/Group Description No advance supply of emergency contraception

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.

All-Cause Mortality
No Advance EC Advance EC Given
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
No Advance EC Advance EC Given
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/23 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
No Advance EC Advance EC Given
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/23 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Arden McAllister
Organization: University of Pennsylvania
Phone: 215-662-3532 ext 267
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00433004     History of Changes
Other Study ID Numbers: 805358
First Submitted: February 8, 2007
First Posted: February 9, 2007
Results First Submitted: May 11, 2017
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017