Intrauterine Device Expulsion
Conditions
Keywords
Postpartum IUD, Cesarean Delivery, 6 months postpartum, satisfaction
Brief summary
The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.
Detailed description
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.
Interventions
DEVICECopper IUD placement at time Cesarean Delivery (Copper T 380A)
Placement of Paragard IUD at time of Cesarean Delivery
Sponsors
Albert Einstein College of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* singleton gestation * greater than 35 weeks gestation * speaks English or Spanish * desires IUD for contraception * undergoing a cesarean delivery
Exclusion criteria
* evidence of chorioamnionitis * history of chlamydia within this pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Expulsion of IUD | 6 week postpartum | Number of participants with Expulsion of IUDs placed at time of cesarean delivery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction of IUD Placement | 6 months postpartum | 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. |
| Number of Participants With Expulsion of IUD | 6 months postpartum | Number of participants with Expulsion of IUDs placed at time of cesarean delivery. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 90 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| 6 Months Postpartum Status | Lost to Follow-up | 12 |
| 6 Weeks Postpartum Status | Lost to Follow-up | 36 |
Baseline characteristics
| Characteristic | Postplacental Insertion of Intrauterine Device (IUD) |
|---|---|
| Age, Customized 20-29 years old | 40 Participants |
| Age, Customized <20 years old | 2 Participants |
| Age, Customized 30-39 years old | 45 Participants |
| Age, Customized 40-49 years old | 3 Participants |
| Indication Elective Repeat | 66 Participants |
| Indication Macrosomia | 8 Participants |
| Indication Malpresentation | 5 Participants |
| Indication Other | 4 Participants |
| Indication Preeclampsia | 3 Participants |
| Indication Shoulder Dystocia | 5 Participants |
| Parity Multiparous | 86 Participants |
| Parity Nulliparous | 4 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black | 31 Participants |
| Race/Ethnicity, Customized Hispanic | 46 Participants |
| Race/Ethnicity, Customized Not Specified | 7 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Region of Enrollment United States | 90 participants |
| Sex: Female, Male Female | 90 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 42 |
| other Total, other adverse events | 23 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
Number of Participants With Expulsion of IUD
Number of participants with Expulsion of IUDs placed at time of cesarean delivery.
Time frame: 6 week postpartum
Population: Fifty-four (54) of ninety (90) participants were able to be reached for a response at 6 weeks either in person or via telephone.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Postplacental Insertion of Intrauterine Device (IUD) | Number of Participants With Expulsion of IUD | IUD Maintained | 54 Participants |
| Postplacental Insertion of Intrauterine Device (IUD) | Number of Participants With Expulsion of IUD | IUD Expelled | 0 Participants |
Secondary
Number of Participants With Expulsion of IUD
Number of participants with Expulsion of IUDs placed at time of cesarean delivery.
Time frame: 6 months postpartum
Population: Forty-two (42) of ninety (90) participants were able to reached at 6 months following IUD placement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Postplacental Insertion of Intrauterine Device (IUD) | Number of Participants With Expulsion of IUD | IUD Maintained | 42 Participants |
| Postplacental Insertion of Intrauterine Device (IUD) | Number of Participants With Expulsion of IUD | IUD Expelled | 0 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.
Time frame: 6 months postpartum
Population: Forty-two (42) of the ninety (90) enrolled participants were able to be reached at 6 months following IUD placement.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Postplacental Insertion of Intrauterine Device (IUD) | Satisfaction of IUD Placement | Very Happy/Happy | 34 Participants |
| Postplacental Insertion of Intrauterine Device (IUD) | Satisfaction of IUD Placement | Somewhat Happy | 4 Participants |
| Postplacental Insertion of Intrauterine Device (IUD) | Satisfaction of IUD Placement | Unsure | 4 Participants |
| Postplacental Insertion of Intrauterine Device (IUD) | Satisfaction of IUD Placement | Unhappy | 0 Participants |