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This is a pilot study of up to 10 women, which will test the hypothesis that the placement of copper IUDs through the uterine incision at the time of uncomplicated elective C-section is technically feasible and acceptable to women seeking long-term contraception.
Women will be enrolled in this study during late prenatal care. Consent for placement of the IUD will be verified prior to elective C-section. After removal of the placenta, the copper IUD will be placed through the incision at the fundus and the tail strings will be delivered through the cervix. Data will be collected about patient bleeding and possible infection during the immediate postoperative period. The visibility of the strings will be verified at discharge and at 2 and 6 weeks postpartum. Fundal placement of the IUD will be verified by ultrasound at the patient's last visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Copper IUD | Experimental | Copper IUD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper IUD ( ParaGard Intrauterine Contraceptive Device) | Device | Intraoperative placement of copper IUD at time of C-section |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Retention of IUD | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visibility Within the Vagina of IUD Strings at All Times. | At 3 days, 2 weeks and 6 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anita L Nelson, MD | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles BRI | Torrance | California | 90502 | United States |
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Women in prenatal clinic were approached in the third trimester if they were to be scheduled for elective C-section. If they were interested in using Copper IUD, their informed consent was obtained. At the time of elective C-section, their continued interest in study participation was verified.
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| ID | Title | Description |
|---|---|---|
| FG000 | Copper IUD | Women undergoing elective C-section who request long-term contraception with Copper IUD. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IUD Placement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Successful Retention of IUD | Posted | Number | participants | 6 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Copper IUD | Women undergoing elective C-section who request long-term contraception with Copper IUD. |
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Pilot study involving only seven subjects, which limits generalizability of findings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anita Nelson | LA BioMed | anitanelsonwhc@earthlink.net |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Visibility Within the Vagina of IUD Strings at All Times. | Posted | Number | participants | At 3 days, 2 weeks and 6 weeks postpartum |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
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