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Trial of Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion

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ClinicalTrials.gov Identifier: NCT00235547
Recruitment Status : Completed
First Posted : October 10, 2005
Results First Posted : June 10, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Abortion
Intervention Behavioral: timing of initiation of transdermal patch after an abortion
Enrollment 298
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Contraception-Immediate Start Contraception-Delayed Start
Hide Arm/Group Description

contraception after abortion and before leaving the clinic, observed by clinic staff

timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic

instructed to begin contraception the first Sunday after leaving the clinic

timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic

Period Title: 2 Month Follow-up Survey
Started 154 144
Completed 108 104
Not Completed 46 40
Period Title: 6 Month Follow-up Survey
Started 154 144
Completed 83 76
Not Completed 71 68
Arm/Group Title Contraception-Immediate Start Contraception-Delayed Start Total
Hide Arm/Group Description

contraception after abortion and before leaving the clinic, observed by clinic staff

timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic

instructed to begin contraception the first Sunday after leaving the clinic

timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic

Total of all reporting groups
Overall Number of Baseline Participants 154 144 298
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants 144 participants 298 participants
21.9  (5.3) 22.5  (5.2) 22.2  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 144 participants 298 participants
Female
154
 100.0%
144
 100.0%
298
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 154 participants 144 participants 298 participants
Latina
53
  34.4%
47
  32.6%
100
  33.6%
African-American
46
  29.9%
45
  31.3%
91
  30.5%
White
25
  16.2%
26
  18.1%
51
  17.1%
Asian/PI
24
  15.6%
24
  16.7%
48
  16.1%
Multiracial/Other
6
   3.9%
2
   1.4%
8
   2.7%
Insurance  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 144 participants 298 participants
Medi-Cal/Emergency Medi-CAl
124
  80.5%
118
  81.9%
242
  81.2%
Private or HMO
11
   7.1%
5
   3.5%
16
   5.4%
Self-pay
19
  12.3%
21
  14.6%
40
  13.4%
BMI  
Mean (Standard Deviation)
Unit of measure:  BMI
Number Analyzed 154 participants 144 participants 298 participants
25.0  (4.5) 24.9  (4.0) 24.9  (4.3)
Prior patch use  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 144 participants 298 participants
53
  34.4%
54
  37.5%
107
  35.9%
1.Primary Outcome
Title Number of Participants Who Use Patch After Abortion, by Study Arm
Hide Description we will also describe what participants were using two months post-abortion
Time Frame six months after enrollment/abortion
Hide Outcome Measure Data
Hide Analysis Population Description
randomized subjects who completed the six month survey
Arm/Group Title Contraception-Immediate Start Contraception-Delayed Start
Hide Arm/Group Description:

contraception after abortion and before leaving the clinic, observed by clinic staff

timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic

instructed to begin contraception the first Sunday after leaving the clinic

timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic

Overall Number of Participants Analyzed 83 76
Measure Type: Count of Participants
Unit of Measure: Participants
36
  43.4%
42
  55.3%
2.Secondary Outcome
Title Number of Participants Who Were Using Effective Method at 6 Months Post-enrollment
Hide Description An effective method is defined as a hormonal method or intra-uterine device
Time Frame six months post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Contraception-Immediate Start Contraception-Delayed Start
Hide Arm/Group Description:

contraception after abortion and before leaving the clinic, observed by clinic staff

timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic

instructed to begin contraception the first Sunday after leaving the clinic

timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic

Overall Number of Participants Analyzed 83 76
Measure Type: Count of Participants
Unit of Measure: Participants
46
  55.4%
49
  64.5%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Contraception-Immediate Start Contraception-Delayed Start
Hide Arm/Group Description

contraception after abortion and before leaving the clinic, observed by clinic staff

timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic

instructed to begin contraception the first Sunday after leaving the clinic

timing of initiation of transdermal patch after an abortion: the initiation of the patch after abortion is dictated by the study as opposed to offering several options (i.e. first Sunday of period). For this arm it is to place the patch in the clinic with clinic staff before leaving the clinic

All-Cause Mortality
Contraception-Immediate Start Contraception-Delayed Start
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Contraception-Immediate Start Contraception-Delayed Start
Affected / at Risk (%) Affected / at Risk (%)
Total   0/154 (0.00%)   0/144 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Contraception-Immediate Start Contraception-Delayed Start
Affected / at Risk (%) Affected / at Risk (%)
Total   0/154 (0.00%)   0/144 (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
Layout table for Results Point of Contact information
Name/Title: Dr. Sarah Prager
Organization: University of Washington
Phone: 415-206-8715
EMail: pragers@uw.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00235547     History of Changes
Other Study ID Numbers: H11779-2703-01
First Submitted: October 6, 2005
First Posted: October 10, 2005
Results First Submitted: March 6, 2019
Results First Posted: June 10, 2019
Last Update Posted: August 29, 2019