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Women having abortions are at high risk for subsequent unintended pregnancy and repeat abortion. Clearly, encouraging contraceptive use after abortion is a high priority. Long acting reversible contraceptives (LARCs, Implants and intrauterine contraception) are the most effective methods to help women avoid a repeat unwanted pregnancy and abortion. Studies in surgical abortion patients, show that "quickstart" of a LARC - i.e., inserting it during the surgical procedure - is associated with substantially greater use of that method six months later than requiring women to return later to get the device. However, today a majority of women chose medical abortion. The clinical routine is to insert LARCs at the follow up 2 to 3 weeks after the abortion treatment. Frequently women choose to do part of the abortion treatment at home and do not return for a follow up. Thus, the possibility to quick start a contraceptive method in medical abortion would be a major advantage especially if this could be done at the time of administration of mifepristone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etonorgestrel and mifepristone | Experimental | Quickstart, insertion of Nexplanon on the day of mifepristone in medical abortion |
|
| mifepristone | Active Comparator | Mifepristone on day 1. Nexplanon insertion at 3 weeks FU after the medical abortion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mifepristone | Drug | Day one of medical abortion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete abortions without surgical intervention | Efficacy of the medical abortion treatment | at 3 weeks follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Unplanned pregnancy | Numbers of pregnancies within the first year following the index abortion | during one year FU |
| Number of women with complications | reports and rates of AE/SAE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Gemzell-Danielsson, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska Universitetssjukhuset/Östra | Gothenburg | Sweden | ||||
| Universitetssjukhuset |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27664217 | Derived | Hognert H, Kopp Kallner H, Cameron S, Nyrelli C, Jawad I, Heller R, Aronsson A, Lindh I, Benson L, Gemzell-Danielsson K. Immediate versus delayed insertion of an etonogestrel releasing implant at medical abortion-a randomized controlled equivalence trial. Hum Reprod. 2016 Nov;31(11):2484-2490. doi: 10.1093/humrep/dew238. Epub 2016 Sep 22. |
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| ID | Term |
|---|---|
| D015735 | Mifepristone |
| C044815 | etonogestrel |
| D003270 | Contraceptive Agents |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| etonorgestrel | Drug |
|
|
| evaluated at the 3weeks FU |
| Rate of implant insertion | Compliance, contraceptive usage | up to 1year FU |
| Bleeding | Bleeding will be evaluated with regard to both bleeding during the medical abortion and bleeding patterns during the one year FU | Evaluated at 1 year FU |
| Linköping |
| Sweden |
| Universitetssjukhuset i Örebro | Örebro | Sweden |
| Karolinska Universitetssjukhuset | Stockholm | 17176 | Sweden |
| Danderyds Hospital | Stockholm | Sweden |
| Södersjukhuset | Stockholm | Sweden |
| Chalmers Sexual and Reproductive Health Service | Edinburgh | EH3 9ES | United Kingdom |
| D011083 |
| Polycyclic Compounds |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |