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Continuation of Subcutaneous and Intramuscular Depot Medroxyprogesterone Acetate in Post-abortion Patients

Continuation Rates of Self-administered Subcutaneous Depot Medroxyprogesterone Acetate and Provider-administered Intramuscular Depot Medroxyprogesterone Acetate in Patients Seeking Post-abortion Contraception

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05505435
Enrollment
263
Registered
2022-08-17
Start date
2022-08-01
Completion date
2024-03-30
Last updated
2026-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contraception

Brief summary

Multiple prior studies have compared self-administered Subcutaneous Depot Medroxyprogesterone Acetate(DMPA-SC) to both provider-administered DMPA-SC and Intramuscular Depot Medroxyprogesterone Acetate (DMPA-IM) and found that continuation rates for self-administered DMPA-SC are higher. Thus far, studies investigating self-administered DMPA-SC have focused on patients presenting for contraception. Self-administered DMPA-SC has not been widely studied in patients seeking abortion and has been more extensively studied in international settings than in the US. The project will be a prospective cohort study of patients at a large, free-standing abortion clinic in Chicago, Illinois. Patients who indicate that they desire DMPA for post-abortion contraception will be recruited. They will choose either provider-administered DMPA-IM or self-administered DMPA-SC. Patients in both groups will complete a baseline survey that will collect demographic and clinical characteristics. Patients who choose self-administered DMPA-SC will receive self-injection teaching from study staff and will self-inject their first dose of DMPA-SC in the clinic. Patients who choose provider-administered DMPA-IM will receive their first dose of DMPA-IM in the clinic. Both groups will receive a prescription for three additional doses of DMPA and will receive an injection calendar. Study participants will receive a reminder prior to the start of the injection window for their second and third doses. After the injection window for the second and third doses closes, participants will complete follow up surveys. These surveys will assess whether patients received the subsequent doses of DMPA, reasons for discontinuing DMPA for patients who did not receive a dose, pregnancy status, and patient satisfaction with DMPA use. Follow up will be primarily via secure text messaging application with phone calls, email, and mail reserved for patients who cannot or prefer not to be contacted via text message. The primary outcome is continuation rates of DMPA-IM and DMPA-SC at 3 and 6 months after initiation. Secondary outcome measures include pregnancy, adverse effects, and patient satisfaction. We will also determine associations between patients' demographic and clinical characteristics and continuation of DMPA. This project will generate evidence that will support expanding access to DMPA-SC and providing patient education on self-injection, allowing for increased patient contraceptive autonomy.

Interventions

subcutaneous depot medroxyprogesterone acetate

Sponsors

Northwestern University
Lead SponsorOTHER
Society of Family Planning
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patient planning DMPA for post-abortion contraception.

Exclusion criteria

* Patient cannot speak and read English.

Design outcomes

Primary

MeasureTime frameDescription
DMPA Continuation Rate6 monthsContinuation rates of DMPA-SC and DMPA-IM at 6 months via patient report

Secondary

MeasureTime frameDescription
DMPA Continuation Rate3 monthsContinuation rate of DMPA-SC and DMPA-IM at 3 months by patient report
Patient Satisfaction and Ease of Use6 monthsParticipants were given a study-bespoke questionnaire with 2 items each scored from 0 to 4 to gauge satisfaction and ease of use. Min score 0, max score 8 with higher scores indicating greater ease of use and satisfaction.

Countries

United States

Participant flow

Recruitment details

Of the 274 consented participants, 263 enrolled in the study and were included in the study.

Pre-assignment details

Of the 274 consented participants, 11 were not enrolled because they did not receive DMPA according to study protocol

Baseline characteristics

Characteristic—
Age, Continuous27.7 Years
STANDARD_DEVIATION 5.3
Annual Household Income30000 U.S. Dollars
Employment Status
Full Time
43 Participants
Employment Status
In School
9 Participants
Employment Status
Not Employed
47 Participants
Employment Status
Part Time
29 Participants
Employment Status
Unknown/missing
3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
44 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
216 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Gravidity4 Number of total pregnancies
Highest level of education
Associate's
21 Participants
Highest level of education
Bachelor's
5 Participants
Highest level of education
Doctorate
0 Participants
Highest level of education
High school diploma/GED
123 Participants
Highest level of education
Less than high school
7 Participants
Highest level of education
Master's
0 Participants
Highest level of education
Some College
49 Participants
Highest level of education
Unknown/missing
1 Participants
Insurance Type
Medicaid
112 Participants
Insurance Type
Medicare
19 Participants
Insurance Type
None
20 Participants
Insurance Type
Other
6 Participants
Insurance Type
Private
3 Participants
Insurance Type
Unknown/missing
8 Participants
Parity2 Number of births
Prior abortions1 Number of prior abortions
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
200 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
28 Participants
Relationship Status
Divorced
4 Participants
Relationship Status
Long term relationship
15 Participants
Relationship Status
Married
5 Participants
Relationship Status
Other
5 Participants
Relationship Status
Separated
4 Participants
Relationship Status
Single
212 Participants
Relationship Status
Unknown/missing
1 Participants
Relationship Status
Widowed
0 Participants
Sex: Female, Male
Female
157 Participants
Sex: Female, Male
Male
0 Participants
Sexuality
Bisexual
9 Participants
Sexuality
Gay/Lesbian
0 Participants
Sexuality
Other
0 Participants
Sexuality
Straight
95 Participants
Sexuality
Unknown/Missing
0 Participants
Type of Abortion
Medication
52 Participants
Type of Abortion
Procedural
82 Participants
Type of Abortion
Unknown/Missing
1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1060 / 157
other
Total, other adverse events
0 / 1060 / 157
serious
Total, serious adverse events
0 / 1060 / 157

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 16, 2026