Trial Outcomes & Findings for Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II (NCT NCT02411357)
NCT ID: NCT02411357
Last Updated: 2023-02-10
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
138 participants
Primary outcome timeframe
6 months after randomization
Results posted on
2023-02-10
Participant Flow
Participant milestones
| Measure |
Usual Care
The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities.
|
Contraceptive Services
The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction.
|
Contraceptive Services + Incentives
The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits.
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
42
|
|
Overall Study
COMPLETED
|
48
|
48
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
Baseline characteristics by cohort
| Measure |
Usual Care
n=48 Participants
The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities.
|
Contraceptive Services
n=48 Participants
The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction.
|
Contraceptive Services + Incentives
n=42 Participants
The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits.
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
30.6 years
STANDARD_DEVIATION 6.0 • n=99 Participants
|
32.0 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
31.6 years
STANDARD_DEVIATION 4.9 • n=206 Participants
|
31.4 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
138 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
138 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
128 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
One or more unintended pregnancies in lifetime
|
41 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
122 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 months after randomizationOutcome measures
| Measure |
Usual Care
n=48 Participants
The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities.
|
Contraceptive Services
n=48 Participants
The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction.
|
Contraceptive Services + Incentives
n=42 Participants
The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits.
|
|---|---|---|---|
|
Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment
|
5 Participants
|
14 Participants
|
23 Participants
|
Adverse Events
Usual Care
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Contraceptive Services
Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths
Contraceptive Services + Incentives
Serious events: 1 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=48 participants at risk
The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities.
|
Contraceptive Services
n=48 participants at risk
The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction.
|
Contraceptive Services + Incentives
n=42 participants at risk
The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Ruptured ectopic pregnancy
|
2.1%
1/48 • 6 months
|
0.00%
0/48 • 6 months
|
0.00%
0/42 • 6 months
|
|
Surgical and medical procedures
Infection secondary to surgical incision
|
2.1%
1/48 • 6 months
|
0.00%
0/48 • 6 months
|
0.00%
0/42 • 6 months
|
|
Psychiatric disorders
Opioid overdose
|
0.00%
0/48 • 6 months
|
2.1%
1/48 • 6 months
|
0.00%
0/42 • 6 months
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/48 • 6 months
|
2.1%
1/48 • 6 months
|
0.00%
0/42 • 6 months
|
|
Psychiatric disorders
Cardiac arrest secondary to probable bupropion overdose
|
0.00%
0/48 • 6 months
|
2.1%
1/48 • 6 months
|
0.00%
0/42 • 6 months
|
|
Psychiatric disorders
Hospitalization for depression/suicidality
|
0.00%
0/48 • 6 months
|
0.00%
0/48 • 6 months
|
2.4%
1/42 • 6 months
|
Other adverse events
| Measure |
Usual Care
n=48 participants at risk
The usual care condition received usual care consisting of a general information brochure about contraceptive methods and contact information for community contraceptive service facilities.
|
Contraceptive Services
n=48 participants at risk
The contraceptive services condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visits to assess method satisfaction.
|
Contraceptive Services + Incentives
n=42 participants at risk
The contraceptive services + incentives condition were offered onsite contraceptive services adapted from the World Health Organization including 6 months of follow-up visit to assess method satisfaction plus financial incentives for attending follow-up visits.
|
|---|---|---|---|
|
General disorders
Adverse events not categorized by organ system
|
54.2%
26/48 • Number of events 46 • 6 months
|
87.5%
42/48 • Number of events 176 • 6 months
|
85.7%
36/42 • Number of events 230 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place