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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 306-312 |
| Number of pages | 7 |
| Journal | Obstetrics and Gynecology |
| Volume | 127 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 1 2016 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Obstetrics and Gynecology
Cite this
Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy. / Raymond, Elizabeth G.; Weaver, Mark A.; Tan, Yi Ling; Louie, Karmen S.; Bousiéguez, Manuel; Lugo-Hernández, Elba M.; Aranguré-Peraza, Ana Gabriela; Sanhueza, Patricio; Kaplan, Clair; Sonalkar, Sarita; Goldberg, Alisa B.; Culwell, Kelly R.; Memmel, Lisa; Jamshidi, Roxanne; Winikoff, Beverly.
In: Obstetrics and Gynecology, Vol. 127, No. 2, 01.02.2016, p. 306-312.Research output: Contribution to journal › Article
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TY - JOUR
T1 - Effect of Immediate Compared With Delayed Insertion of Etonogestrel Implants on Medical Abortion Efficacy and Repeat Pregnancy
AU - Raymond, Elizabeth G.
AU - Weaver, Mark A.
AU - Tan, Yi Ling
AU - Louie, Karmen S.
AU - Bousiéguez, Manuel
AU - Lugo-Hernández, Elba M.
AU - Aranguré-Peraza, Ana Gabriela
AU - Sanhueza, Patricio
AU - Kaplan, Clair
AU - Sonalkar, Sarita
AU - Goldberg, Alisa B.
AU - Culwell, Kelly R.
AU - Memmel, Lisa
AU - Jamshidi, Roxanne
AU - Winikoff, Beverly
PY - 2016/2/1
Y1 - 2016/2/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84955448254&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84955448254&partnerID=8YFLogxK
U2 - 10.1097/AOG.0000000000001274
DO - 10.1097/AOG.0000000000001274
M3 - Article
C2 - 26942358
AN - SCOPUS:84955448254
VL - 127
SP - 306
EP - 312
JO - Obstetrics and Gynecology
JF - Obstetrics and Gynecology
SN - 0029-7844
IS - 2
ER -