Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.
This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copper IUD placement at time Cesarean Delivery (Copper T 380A) | Device | Placement of Paragard IUD at time of Cesarean Delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Expulsion of IUD | Number of participants with Expulsion of IUDs placed at time of cesarean delivery. | 6 week postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of IUD Placement | Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale ("Very Happy/Happy", "Somewhat Happy", "Unsure", "Unhappy") was used to evaluate participants' attitude toward the IUD. | 6 months postpartum |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Amitasrigowri Murthy, MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jacobi Medical Center | The Bronx | New York | 10461 | United States | ||
| Montefiore Medical Center, Weiler Division |
Not provided
Recruitment took place in two Bronx medical centers. During prenatal care, all women were counseled regarding contraception. Women who intended to use the copper T380A IUD postpartum were approached and informed about the study after arriving on labor and delivery. Women undergoing cesarean delivery at >= 35 weeks of gestation and who met all of the inclusion and none of the exclusion criteria were enrolled into the study upon signing informed consent.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Postplacental Insertion of Intrauterine Device (IUD) | This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6 Weeks Postpartum Status |
|
| ||||||||||||||||||
| 6 Months Postpartum Status |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Postplacental Insertion of Intrauterine Device (IUD) | This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Number of Participants With Expulsion of IUD | Number of participants with Expulsion of IUDs placed at time of cesarean delivery. | Fifty-four (54) of ninety (90) participants were able to be reached for a response at 6 weeks either in person or via telephone. | Posted | Count of Participants | Participants | 6 week postpartum |
|
6 months postpartum
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 | Postplacental Insertion of Intrauterine Device (IUD) | This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heavy menstrual bleeding | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erika Levi | Albert Einstein College of Medicine | 718-405-8260 | elevi@montefiore.org |
Not provided
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Number of Participants With Expulsion of IUD | Number of participants with Expulsion of IUDs placed at time of cesarean delivery. | 6 months postpartum |
| The Bronx |
| New York |
| 10461 |
| United States |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Parity | Nulliparous participants were identified as those who had no previous childbirths and Multiparous participants were defined as those that had at least one previous childbirth. | Count of Participants | Participants |
|
| Indication | Overall count of 91 participants as the indication categories were not considered to be mutually exclusive (i.e., more than 1 indication could have been selected for participants who were not categorized as 'Elective Repeat'). In this context, indication describes the condition the participant presented with during consent and enrollment into the study. | Count of Participants | Participants |
|
|
|
| Secondary | Satisfaction of IUD Placement | Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale ("Very Happy/Happy", "Somewhat Happy", "Unsure", "Unhappy") was used to evaluate participants' attitude toward the IUD. | Forty-two (42) of the ninety (90) enrolled participants were able to be reached at 6 months following IUD placement. | Posted | Count of Participants | Participants | 6 months postpartum |
|
|
|
| Secondary | Number of Participants With Expulsion of IUD | Number of participants with Expulsion of IUDs placed at time of cesarean delivery. | Forty-two (42) of ninety (90) participants were able to reached at 6 months following IUD placement. | Posted | Count of Participants | Participants | 6 months postpartum |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 23 |
| 42 |
| Cramping | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Unhappy |
|