Study Results
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View full resultsBasic Information
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COMPLETED
NA
148 participants
INTERVENTIONAL
2014-06-30
2017-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Immediate Nexplanon Insertion
An etonogestrel rod will be placed within 15 minutes following the abortion procedure.
Immediate Nexplanon Insertion
Patient will have a Nexplanon inserted within 15 minutes of her abortion
Post-op Nexplanon Insertion
Participants in the "delayed" placement group will be asked to return to Magee-Womens Hospital for a post-abortion visit 2-4 weeks following the procedure. Participants in the delayed group will be offered a method of contraception to use in the interim between their procedure and their insertion appointment. At this time an etonogestrel rod will be placed in her arm using standard procedure.
Post-op Nexplanon Insertion
Place Nexplanon at post operative visit rather than at surgery
Interventions
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Immediate Nexplanon Insertion
Patient will have a Nexplanon inserted within 15 minutes of her abortion
Post-op Nexplanon Insertion
Place Nexplanon at post operative visit rather than at surgery
Eligibility Criteria
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Inclusion Criteria
* an intrauterine pregnancy \> 14 weeks and \<23 6/7 weeks gestation and desire termination of pregnancy
* desire a Nexplanon for contraception
* able to give informed consent in English
* no contraindications to Nexplanon (based on U.S. CDC Medical Eligibility Criteria for Contraception) or D\&E
Exclusion Criteria
* have any of the following medical conditions: active venous thromboembolism, known or suspected sex-steroid sensitive malignancies, current hepatic disease with abnormal liver function tests, undiagnosed vaginal bleeding, hypersensitivity to any of the ingredients in Nexplanon.
* non-surgical management of pregnancy
* prior participation in this study
* breast cancer or a history of breast cancer
18 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
The Cleveland Clinic
OTHER
Family Planning Associates Medical Group, LTD
OTHER
Responsible Party
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Allison Cowett, MD MPH
Associate Medical Director
Principal Investigators
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Miriam Cremer, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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Family Planning Associates Medical Grooup, LTD
Chicago, Illinois, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IIS#50302: Women's Health MISP
Identifier Type: -
Identifier Source: org_study_id
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