Contraception
Conditions
Keywords
Postpartum contraception, Copper IUD
Brief summary
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.
Detailed description
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.
Interventions
DEVICECopper IUD ( ParaGard Intrauterine Contraceptive Device)
Intraoperative placement of copper IUD at time of C-section
Sponsors
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant woman * Requires elective C-section * Desires long-term contraception
Exclusion criteria
* Contraindications to copper IUD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful Retention of IUD | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Visibility Within the Vagina of IUD Strings at All Times. | At 3 days, 2 weeks and 6 weeks postpartum |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| IUD Placement | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | IUD Placement |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | NA years |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Successful Retention of IUD
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IUD Placement | Successful Retention of IUD | 7 participants |
Secondary
Visibility Within the Vagina of IUD Strings at All Times.
Time frame: At 3 days, 2 weeks and 6 weeks postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IUD Placement | Visibility Within the Vagina of IUD Strings at All Times. | 7 participants |