Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| The Cleveland Clinic | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Women who receive Nexplanon immediately post abortion will be significantly more likely to be using the device 6 months after the procedure than those assigned to receive the device 2-4 weeks after the procedure.
Women will be contacted 6 months after their abortion to ask about contraception use and side effects.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Nexplanon Insertion | Experimental | An etonogestrel rod will be placed within 15 minutes following the abortion procedure. |
|
| Post-op Nexplanon Insertion | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Nexplanon Insertion | Other | Patient will have a Nexplanon inserted within 15 minutes of her abortion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intention-to-treat Analysis of Etonogestrel Implant Use | Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with all entire sample used in calculations. | 6 months |
| Per-protocol Analysis of Etonogestrel Implant Use | Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with only participants who completed the 6-month follow-up used in calculations. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Repeat Pregnancy | Occurrence of a pregnancy within 6 months after second-trimester abortion. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Implant Inserted | Whether participants had the implant inserted as part of the study | Within 4 weeks of abortion |
| Completed 6-month Phone Call | Whether participants completed 6-month phone call follow-up. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Miriam Cremer, MD, MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Planning Associates Medical Grooup, LTD | Chicago | Illinois | 60661 | United States | ||
| University of Pittsburgh |
Participants were randomized.
A total of 148 participants were recruited and randomized into two study arms.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Post-op Nexplanon Insertion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intention-to-treat Analysis of Etonogestrel Implant Use | Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with all entire sample used in calculations. | Posted | Count of Participants | Participants | 6 months |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and Vomiting | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison A. Cowett, MD MPH | Family Planning Associates Medical Group , Ltd. | 312-707-8988 | aacowett@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 22, 2015 | Sep 6, 2018 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 30, 2015 | Sep 5, 2018 | ICF_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Post-op Nexplanon Insertion | Other | Place Nexplanon at post operative visit rather than at surgery |
|
| 6 months |
| Pittsburgh |
| Pennsylvania |
| 15213 |
| United States |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Positive Smoking Status | Count of Participants | Participants |
|
| Insurance Type | Count of Participants | Participants |
|
| Using insurance for D&E | Count of Participants | Participants |
|
| Latina | Count of Participants | Participants |
|
| Total no. of pregnancies | Median | Full Range | Number of pregnancies |
|
| No. of children alive | Median | Full Range | Number of children alive |
|
| Prior D&E | Count of Participants | Participants |
|
| D&E indication | Count of Participants | Participants |
|
| Birth control methods used in the past | Count of Participants | Participants |
|
| History of STI | Count of Participants | Participants |
|
|
|
| Primary | Per-protocol Analysis of Etonogestrel Implant Use | Current use of Etonogestrel implant, confirmed via phone by participant palpation, at 6 months post-insertion, with only participants who completed the 6-month follow-up used in calculations. | Calculated using only participants who completed the 6-month follow-up. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Repeat Pregnancy | Occurrence of a pregnancy within 6 months after second-trimester abortion. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | Implant Inserted | Whether participants had the implant inserted as part of the study | Posted | Count of Participants | Participants | Within 4 weeks of abortion |
|
|
|
| Other Pre-specified | Completed 6-month Phone Call | Whether participants completed 6-month phone call follow-up. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 0 |
| 73 |
| 0 |
| 73 |
| 2 |
| 73 |
| EG001 | Post-op Nexplanon Insertion | Participants in the "delayed" placement group will be asked to return to Family Planning Associates 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 | 0 | 75 | 0 | 75 | 1 | 75 |
| Rapid weight loss | Metabolism and nutrition disorders | Systematic Assessment |
|
| Post abortal endometritis | Reproductive system and breast disorders | Systematic Assessment |
|
| Pregnancy | Reproductive system and breast disorders | Systematic Assessment |
|
Not provided
Not provided
| Implant never placed |
|