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This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.
The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.
This was a single arm cohort study of women who desired to receive a levonorgestrel releasing intrauterine system (LNG-IUS) within 48 hours of uncomplicated vaginal delivery.
Women were enrolled during a prenatal care visit when they reported they desired to use the LNG-IUS after the birth of their infant.
Forty women stated enrolled in the study prior to labor, and baseline data were obtained. After delivery 29 women remained both interested in the study and were still eligible to receive the LNG-IUS prior to discharge from the hospital.
Of the 29 women who received the LNG-IUS prior to discharge from the hospital 11 women had an LNG-IUS expulsion prior to 6 months postpartum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complete Cohort | Other | The complete cohort of all women enrolled and stated they wanted an LNG-IUS between 48 and 72 hours of vaginal delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration | Drug | Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| IUD Expulsion | Expulsion of the LNG-IUS | From time of insertion to final study date which is 6 months after IUD insertion. |
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Inclusion Criteria:
Exclusion Criteria:
Prior cesarean delivery
Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy
Allergic to betadine
Allergy to lidocaine
Medical or personal conditions which in the judgment of study staff contradict participation in the study
Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ
After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen Stuart, MD, MPHTM | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
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All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Insertion | Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery. Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Immediate Insertion | Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery. Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The results are presented for the 29 women who received the IUD. Baseline data are presented for the 29 women who received the IUD and the 11 women who did not. |
| 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 | IUD Expulsion | Expulsion of the LNG-IUS | Posted | Count of Participants | Participants | From time of insertion to final study date which is 6 months after IUD insertion. |
|
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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 | Immediate Insertion | Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery. Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. G Stuart | University of North Carolina School of Medicine | 919-962-4880 | gstuart@med.unc.edu |
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| ID | Term |
|---|---|
| D013995 | Time |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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|
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | females only because this was a female contraception study | All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race White Black Other Hispanic ethnicity | All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital. | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Previous contraceptive use, marital status, employment, | All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital. | Count of Participants | Participants |
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | No IUD Insertion | Women in this group underwent baseline data collection, stated they would like to enroll and receive an IUD between 10 minutes and 48 hours postpartum. These women were not eligible to receive the IUD due to delivery elsewhere, medical complications in peri-partum period. | 0 | 11 | 0 | 11 |
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