Four-week delay feasible for DMPA reinjection — will protocols change?
Four-week delay feasible for DMPA reinjection — will protocols change?
Study leads to extension of international reinjection grace period
Extending the current grace period for reinjection of the contraceptive shot depot medroxyprogesterone acetate (DMPA, Depo-Provera, Pfizer) from two to four weeks does not increase pregnancy risk and could increase contraceptive continuation, indicate findings from a newly published study.1
This new research has led the World Health Organization (WHO) Expert Working Group On Family Guidance to reconsider the issue of the timing of repeat injections of DMPA, take a fresh look at the body of evidence on the issue, and change its recommendations, says Catherine d'Arcangues, PhD, MD, coordinator of the Director's Office and acting coordinator of the Family Planning Department of Reproductive Health and Research at WHO.
The international agency's updated recommendations are included in the 2008 publication, Family Planning: A Global Handbook for Providers, published with the Johns Hopkins Bloomberg School of Public Health/ Center for Communication Programs' INFO Project. (Editor's note: To access the handbook, visit the INFO Project web site, www.infoforhealth.org. Under "Featured Links," click on"Family Planning: A Global Handbook for Providers.")
The new WHO guidance states "a woman may have an injection of the progestin-only depot-medroxyprogesterone acetate (DMPA) up to four weeks late. There is no need for other indications that she is not pregnant. Her next appointment still should be planned for three months. (Previous guidance said that she could have her DMPA reinjection up to two weeks late.)"2
This change in policy will provide women around the world improved access to this widely used method, says Markus Steiner, PhD, senior epidemiologist at Family Health International and lead author of the research. "We are optimistic that U.S. guidance will be changed soon to be in line with this WHO guidance," he says.
Review the research
The new research was derived from a recently completed prospective cohort study, the "Hormonal Contraception and the Risk of HIV Acquisition Study," which evaluated the association between hormonal contraceptive methods and HIV acquisition.3 This large cohort study followed women for up to 24 months, which offered researchers a unique opportunity to evaluate the risk of pregnancy among DMPA users returning late for reinjections.
To conduct the current analysis, scientists constructed a prospective cohort study in Uganda, Zimbabwe, and Thailand to follow DMPA users for up to 24 months. Users were tested for pregnancy at every reinjection, which allowed analysis of pregnancy risk among those late for reinjection.
Researchers looked at 2,290 participants contributing 13,608 DMPA intervals. The pregnancy risks per 100 women-years for "on-time" patients [0.6; 95% confidence interval (CI), 0.33-0.92], "two-week grace" patients (0.0; 95% CI, 0.0-1.88), and "four-week grace" (0.4; 95% CI, 0.01-2.29) injections were low and virtually identical, researchers report.
What do you do?
When a woman using DMPA is past 13 weeks for her shot, what steps are required by your clinic's protocol before she can receive her reinjection?
For years now, family planning programs have encouraged women to return for a DMPA injection each 11 or 12 weeks, notes Robert Hatcher, MD, MPH, professor of gynecology and obstetrics at Emory University School of Medicine in Atlanta. If women exceed 12 weeks, or in some programs 13 weeks, by as much as a day, the clinic must "jump through hoops" to give a woman her next injection, he notes. Such "hoops" might include:
- a pregnancy test;
- returning to the clinic in seven days, 10 days, or 14 days following the use of condoms during that period of time;
- repeating the pregnancy test in seven days, 10 days, or 14 days prior to giving an injection.
In many instances, by the time those women have completed the process of evaluation or have decided not to take the steps a specific clinic requires, they have become pregnant or discontinued the use of the method, Hatcher observes.
According to the package insert for DMPA, the recommended dose for the drug is 150 mg DMPA every three months (13 weeks) administered by deep, IM injection in the gluteal or deltoid muscle. If the time interval between injections is greater than 13 weeks, the provider should determine that the patient is not pregnant before administering the drug, the package insert states.4
Hatcher notes previous WHO guidance on reinjection stated that repeat injection for DMPA could be given up to two weeks late without requiring additional contraceptive protection.5 Despite that previous guidance, which had been in place for several years, family planning programs in the United States have been extremely slow to respond to the WHO guidelines, he notes.
"Given the impact of DMPA for U.S. teens, it is important that the instructions in the packaging of DMPA and the protocol in family planning clinics and obstetric/gynecology offices be changed to reflect this new information," states Hatcher.
While DMPA remains an extremely effective form of contraception, a recent analysis of the 2002 National Survey of Family Growth found an increase from 5.4% to 6.7% occurred between 1995 and 2002 in the first year probability of failure for the injectable contraceptive.6 While the increase is not statistically significant, it might be due in part to a shift in the composition of the population of women using the method, researchers note.
The greatest increases in the proportion of women using injectables between 1995 and 2002 occurred among Hispanic and non-Hispanic black women, research indicates.7 While researchers found that black women face an elevated risk of failure relative to non-Hispanic white and other contraceptive users when considering all methods combined, they did not have a sufficient number of observations to examine whether the difference holds among DMPA users alone.7
The new research reports findings from developing countries, where the prevalence of lactation is high and the availability of pregnancy tests is low, compared with U.S. contraceptive practice, notes Andrew Kaunitz, MD, professor and associate chair in the Obstetrics and Gynecology Department at the University of Florida College of Medicine–Jacksonville.
For developing countries when pregnancy testing is not available, broadening the "grace period" for reinjections to more than two weeks indeed makes sense, he says.
However, in the U.S. context, the following strategies seem prudent, Kaunitz advises:
- DMPA users returning late for reinjections should not be sent away without their reinjection based on being late.
- DMPA users should be encouraged to return for repeat injections each three months/12 weeks.
- When DMPA users return more than 14 weeks following their last injection, perform a urine pregnancy test in the office, and then perform reinjection if the test is negative.
Clinicians considering use of DMPA should employ use of the "Depo Now" strategy,8,9 which involves providing DMPA at an initial reproductive health visit following a negative in-office pregnancy test, says Kaunitz. This approach facilitates initiation of effective, long-acting injectable contraception, he notes.
References
- Steiner MJ, Kwok C, Stanback J, et al. Injectable contraception: What should the longest interval be for reinjections? Contraception 2008; 77:410-444.
- World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), INFO Project. Family Planning: A Global Handbook for Providers (2008 update). Baltimore and Geneva: CCP and WHO; 2008.
- Morrison CS, Richardson BA, Mmiro F, et al. Hormonal contraception and the risk of HIV acquisition. AIDS 2007; 21:85-95.
- Pfizer. Depo-Provera contraceptive injection. New York City; May 2006.
- World Health Organization [WHO]. Department of Reproductive Health and Research. Selected Practice Recommendations For Contraceptive Use. 2nd ed. Geneva: WHO, Department of Reproductive Health and Research; 2004.
- Kost K, Singh S, Vaughan B, et al. Estimates of contraceptive failure from the 2002 National Survey of Family Growth. Contraception 2008; 77:10-21.
- Frost JJ, Singh S, Finer LB. U.S. women's one-year contraceptive use patterns, 2004. Perspect Sex Reprod Health 2007; 39:48-55.
- Rickert VI, Tiezzi L, Lipshutz J, et al. Depo Now: Preventing unintended pregnancies among adolescents and young adults. J Adolesc Health 2007; 40:22-28.
- Nelson AL, Katz T. Initiation and continuation rates seen in 2-year experience with Same Day injections of DMPA. Contraception 2007; 75:84-87.
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