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1.
Obstet Gynecol ; 128(4): 739-45, 2016 10.
Article in English | MEDLINE | ID: mdl-27607859

ABSTRACT

OBJECTIVE: To evaluate the effects of timing of depot medroxyprogesterone acetate injection on medical abortion outcome and risk of repeat pregnancy within the subsequent 6 months. METHODS: In a multinational randomized trial, we assigned women undergoing medical abortion who wanted depot medroxyprogesterone acetate to administration either with mifepristone (Quickstart group) or after the abortion (Afterstart group). We ascertained abortion outcome, pregnancies, and contraception use over 7 months. RESULTS: From August 2013 to March 2015, we enrolled 461 participants with pregnancy durations of 75 days or less. Of participants included in the abortion outcome analyses, 14 of 220 (6.4%) and 12 of 226 (5.3%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the upper 90% confidence limit on this difference was 4.9%, within our prestipulated 5% noninferiority margin. Ongoing pregnancy after initial abortion treatment was significantly more common in the Quickstart group (8/220 [3.6%]) than in the Afterstart group (2/226 [0.9%]); the difference was 2.7% (90% confidence interval 0.4-5.6%). By 6 months, 5 of 213 (2.3%) and 7 of 217 (3.2%) in the Quickstart and Afterstart groups, respectively, became pregnant (exact log-rank test, P=.64). Use of highly effective contraceptives was significantly more common in the Quickstart group at 31 days (P<.001), but no difference was apparent at 6 months. The Quickstart group was significantly more satisfied with group assignment. CONCLUSION: Depot medroxyprogesterone acetate administration with mifepristone did not appreciably increase the risk of surgery after medical abortion but did increase the risk of ongoing pregnancy. It enhanced patient satisfaction, but we found no evidence that it decreased 6-month risk of repeat pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01902485.


Subject(s)
Abortifacient Agents, Steroidal/administration & dosage , Abortion, Induced , Contraceptive Agents, Female/administration & dosage , Medroxyprogesterone Acetate/administration & dosage , Mifepristone/administration & dosage , Abortion, Induced/adverse effects , Adolescent , Adult , Delayed-Action Preparations/administration & dosage , Female , Humans , Injections, Intramuscular , Patient Satisfaction , Pregnancy , Pregnancy Rate , Time Factors , Treatment Outcome , Young Adult
2.
Obstet Gynecol ; 127(2): 306-12, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26942358

ABSTRACT

OBJECTIVE: To evaluate the effect of insertion of etonogestrel implants with mifepristone compared with after the abortion on the risks of medical abortion failure and repeat pregnancy over the subsequent 6 months. METHODS: In a randomized trial, we assigned patients undergoing medical abortion to receive etonogestrel implants either with the mifepristone (Quickstart group) or after the abortion (Afterstart group). We followed them for 7 months to ascertain abortion outcome, pregnancies, and contraception use. RESULTS: Between September 2013 and August 2014, we enrolled 236 participants in the Quickstart group and 240 in the Afterstart group. To examine abortion failure, we conducted a noninferiority analysis from which we excluded nine participants who had missing outcome data and four with specified protocol violations. Of the rest, 9 of 229 (3.9%) and 9 of 234 (3.8%) in the Quickstart and Afterstart groups, respectively, had surgery to complete the abortion; the difference of 0.08% (90% confidence interval -3.1% to 3.3%) excluded our prestipulated noninferiority margin of 5 percentage points. Among participants with pregnancy follow-up through 6 months, 1 of 213 (0.5%) and 3 of 208 (1.4%) in the Quickstart and Afterstart groups, respectively, became pregnant within that time; 6-month pregnancy rates did not differ significantly by group (exact log-rank test, P=.28). At enrollment, significantly more participants in the Quickstart group than in the Afterstart group were satisfied with their group assignments (187/236 [79%] compared with 129/240 [54%], respectively; P<.001). CONCLUSION: Insertion of etonogestrel implants with mifepristone did not appreciably increase medical abortion failure risk and it enhanced patient satisfaction, but we found no evidence that it decreased repeat pregnancy rates. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01902485.


Subject(s)
Abortion, Therapeutic/methods , Contraceptive Agents, Female/therapeutic use , Desogestrel/therapeutic use , Intrauterine Devices, Medicated/statistics & numerical data , Mifepristone/therapeutic use , Adolescent , Adult , Chi-Square Distribution , Confidence Intervals , Drug Therapy, Combination , Female , Follow-Up Studies , Humans , Patient Satisfaction/statistics & numerical data , Pregnancy , Pregnancy Rate/trends , Risk Assessment , Time Factors , Treatment Failure , Treatment Outcome , Young Adult
3.
Contraception ; 81(2): 123-7, 2010 Feb.
Article in English | MEDLINE | ID: mdl-20103449

ABSTRACT

BACKGROUND: Intrauterine contraception can provide adolescents with effective, long-term contraception as well as with other health benefits. In adult populations, intrauterine contraception rates highly in patient satisfaction and safety. It is rarely prescribed to adolescents because of limited data. STUDY DESIGN: Multicenter, randomized, controlled, participant-blinded pilot study of 14-18-year-old females assigned to the Copper T 380A intrauterine device or the Levonorgestrel Intrauterine System. Participants were followed up for 6 months following insertion. RESULTS: We enrolled 23 participants; 12 received the Levonorgestrel Intrauterine System, and 11 received the Copper T 380A. At 6 months, the continuation rates were 75% for the Levonorgestrel Intrauterine System users and 45% for the Copper T 380A users (p=.15). Two Copper T 380A users experienced partial expulsion. Heavy bleeding and pelvic pain were the most commonly reported side effects. Participants rated both methods favorably. CONCLUSIONS: This study shows that at 6 months, though not statistically significant, adolescent continuation rates trended towards being greater with the Levonorgestrel Intrauterine System compared to the Copper T 380A. These pilot data will be helpful in the design of a larger trial of intrauterine contraception use among adolescents.


Subject(s)
Intrauterine Devices, Copper/adverse effects , Intrauterine Devices, Medicated/adverse effects , Levonorgestrel/administration & dosage , Levonorgestrel/adverse effects , Patient Satisfaction , Adolescent , Contraception/methods , Contraceptive Agents, Female/adverse effects , Female , Humans , Intention to Treat Analysis , Pilot Projects , Single-Blind Method
4.
Contraception ; 73(4): 372-5, 2006 Apr.
Article in English | MEDLINE | ID: mdl-16531170

ABSTRACT

OBJECTIVE: The purpose of this study is to measure the accessibility to purchase oral and transdermal contraceptives over the Internet for low- and high-risk individuals. METHODS: The Internet was used to search for and order both oral and transdermal contraceptives. Using the "Google" search engine to locate online pharmacies by entering the term "purchase contraception," we proceeded to purchase either oral contraceptives or contraceptive patches without a prescription. We first posed as a healthy 25-year-old woman, then as a 35-year-old woman who was obese and a heavy tobacco user, and finally, as a 35-year-old smoker on an antihypertensive medication. RESULTS: Our attempts to order both combination oral contraceptives, as well as contraceptive patches, over the Internet without a prescription were successful for all three risk profiles. We ordered from three different Web sites, two within the United States and one international site. The two U.S. Web sites required us to complete a medical questionnaire to obtain a prescription from the site provider, but the foreign site had no questionnaire or risk information posted on the Web site. Despite entering known risk factors for estrogen use, we received all the medications. There was no medical follow-up to these sales except for offers to sell more products. CONCLUSIONS: Both oral and transdermal contraceptives are easy to obtain over the Internet without a physical appointment with a health care provider to obtain a prescription.


Subject(s)
Contraceptive Agents, Female/adverse effects , Drug Prescriptions , Internet , Administration, Cutaneous , Contraceptives, Oral, Hormonal/adverse effects , Female , Humans , Pharmacies , Physical Examination , Risk Factors
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