Trial Outcomes & Findings for Trial of Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion (NCT NCT00235547)
NCT ID: NCT00235547
Last Updated: 2019-08-29
Results Overview
we will also describe what participants were using two months post-abortion
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
298 participants
Primary outcome timeframe
six months after enrollment/abortion
Results posted on
2019-08-29
Participant Flow
Participant milestones
| Measure |
Contraception-Immediate Start
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
|
Contraception-Delayed Start
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
|
|---|---|---|
|
2 Month Follow-up Survey
STARTED
|
154
|
144
|
|
2 Month Follow-up Survey
COMPLETED
|
108
|
104
|
|
2 Month Follow-up Survey
NOT COMPLETED
|
46
|
40
|
|
6 Month Follow-up Survey
STARTED
|
154
|
144
|
|
6 Month Follow-up Survey
COMPLETED
|
83
|
76
|
|
6 Month Follow-up Survey
NOT COMPLETED
|
71
|
68
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trial of Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion
Baseline characteristics by cohort
| Measure |
Contraception-Immediate Start
n=154 Participants
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
|
Contraception-Delayed Start
n=144 Participants
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
n=298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.9 years
STANDARD_DEVIATION 5.3 • n=99 Participants
|
22.5 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
22.2 years
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=99 Participants
|
144 Participants
n=107 Participants
|
298 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Latina
|
53 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African-American
|
46 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian/PI
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Multiracial/Other
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Insurance
Medi-Cal/Emergency Medi-CAl
|
124 Participants
n=99 Participants
|
118 Participants
n=107 Participants
|
242 Participants
n=206 Participants
|
|
Insurance
Private or HMO
|
11 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Insurance
Self-pay
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
BMI
|
25.0 BMI
STANDARD_DEVIATION 4.5 • n=99 Participants
|
24.9 BMI
STANDARD_DEVIATION 4.0 • n=107 Participants
|
24.9 BMI
STANDARD_DEVIATION 4.3 • n=206 Participants
|
|
Prior patch use
|
53 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: six months after enrollment/abortionPopulation: randomized subjects who completed the six month survey
we will also describe what participants were using two months post-abortion
Outcome measures
| Measure |
Contraception-Immediate Start
n=83 Participants
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
|
Contraception-Delayed Start
n=76 Participants
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
|
|---|---|---|
|
Number of Participants Who Use Patch After Abortion, by Study Arm
|
36 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: six months post enrollmentAn effective method is defined as a hormonal method or intra-uterine device
Outcome measures
| Measure |
Contraception-Immediate Start
n=83 Participants
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
|
Contraception-Delayed Start
n=76 Participants
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
|
|---|---|---|
|
Number of Participants Who Were Using Effective Method at 6 Months Post-enrollment
|
46 Participants
|
49 Participants
|
Adverse Events
Contraception-Immediate Start
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Contraception-Delayed Start
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place