Study of Self or Clinic Administration of DepoProvera
| Status: | Completed |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/16/2018 |
| Start Date: | March 2010 |
| End Date: | November 2012 |
Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate
Depot medroxyprogesterone acetate (DepoProvera) is an acceptable form of contraception for
many women. However, difficulty in access may cause many women to discontinue use, often
without the use of another effective method of contraception, thereby leaving them vulnerable
to unintended pregnancy. This study will randomly assign women who present for contraceptive
services to two groups: self or clinic administered SC DMPA. The participants will be
followed for one year to compare continuation rates, acceptability, cost effectiveness,
evidence of skin changes, and need for continued support between the two groups.
many women. However, difficulty in access may cause many women to discontinue use, often
without the use of another effective method of contraception, thereby leaving them vulnerable
to unintended pregnancy. This study will randomly assign women who present for contraceptive
services to two groups: self or clinic administered SC DMPA. The participants will be
followed for one year to compare continuation rates, acceptability, cost effectiveness,
evidence of skin changes, and need for continued support between the two groups.
Unintended pregnancy remains a worldwide problem in both developed and developing countries.
In 2001, 49% of pregnancies in the United States were unintended. Moreover, more than 6
million women annually are at high risk of becoming unintentionally pregnant because of a gap
in contraceptive use, and disadvantaged women are more likely to have more difficulty than
others with continuous method use. Multiple strategies have been explored and implemented to
increase the effective usage of contraception, including promoting the use of longer acting
reversible contraceptives.
Difficulty in access to depot medroxyprogesterone acetate (DMPA) remains a problem. With the
advent of a subcutaneous formulation of DMPA, administration outside of the clinical setting
is possible. The acceptability of self administered DMPA has also been reviewed, with
favorable outcomes; however, the actual intervention has not been studied.
This study will recruit women presenting for abortion or contraceptive services at the
Columbia University and New York Presbyterian affiliated Family Planning Clinic and Special
Gynecology Services who desire DMPA for contraception. Women will be randomized to two
groups: self administration of SC DMPA or clinic administration of SC DMPA. The primary
objective of this study is to compare the continuation rates of SC DMPA between the self and
clinic administration groups at 6 months. Secondary outcomes include participant
satisfaction, cost effectiveness of self-injected use of DMPA, baseline predictors of method
continuation or discontinuation, evidence of persistent skin changes following administration
of SC DMPA, and need for continued clinical support.
In 2001, 49% of pregnancies in the United States were unintended. Moreover, more than 6
million women annually are at high risk of becoming unintentionally pregnant because of a gap
in contraceptive use, and disadvantaged women are more likely to have more difficulty than
others with continuous method use. Multiple strategies have been explored and implemented to
increase the effective usage of contraception, including promoting the use of longer acting
reversible contraceptives.
Difficulty in access to depot medroxyprogesterone acetate (DMPA) remains a problem. With the
advent of a subcutaneous formulation of DMPA, administration outside of the clinical setting
is possible. The acceptability of self administered DMPA has also been reviewed, with
favorable outcomes; however, the actual intervention has not been studied.
This study will recruit women presenting for abortion or contraceptive services at the
Columbia University and New York Presbyterian affiliated Family Planning Clinic and Special
Gynecology Services who desire DMPA for contraception. Women will be randomized to two
groups: self administration of SC DMPA or clinic administration of SC DMPA. The primary
objective of this study is to compare the continuation rates of SC DMPA between the self and
clinic administration groups at 6 months. Secondary outcomes include participant
satisfaction, cost effectiveness of self-injected use of DMPA, baseline predictors of method
continuation or discontinuation, evidence of persistent skin changes following administration
of SC DMPA, and need for continued clinical support.
Inclusion Criteria:
1. age greater than or equal to 18 years
2. seeking DMPA for contraception
3. English or Spanish speaking
4. consistent access to a working telephone
5. availability for follow up for one year
Exclusion Criteria:
1. suspected or continuing pregnancy
2. undiagnosed vaginal bleeding
3. known or suspected breast cancer
4. acute liver disease
5. known hypersensitivity to medroxyprogesterone acetate or any other components of DMPA
6. desire for pregnancy within one year
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