Contraception
Conditions
Keywords
Postplacental IUD placement, LNG-IUS
Brief summary
The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate postpartum setting offers many advantages and is considered safe, but the risk of expulsion appears to be higher than with interval insertion. Previous studies have shown the rate of expulsion of the copper IUD in the postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While studies related to the copper IUD use ring forceps or the operator's hand for placement of the IUD, the only published study investigating immediate postplacental levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore ask the question, is there a difference in expulsion rates between levonorgestrel and copper IUDs placed post-placentally when all providers undergo a standardized training, use a standardized insertion technique, and when patient level characteristics are controlled by randomization? The investigators propose to perform a prospective cohort trial comparing the rates of expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the uterus within 10 minutes of the delivery of the placenta, using a standardized technique (placement with a ring forceps or the operator's hand) after all providers undergo a formal didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has a higher rate of expulsion as compared to the copper IUD. Additional objectives include a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the investigators will document the natural history of the location of the IUD within the uterus when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks, and 3 months postpartum, to better understand the relationship between position of the IUD and subsequent expulsion.
Interventions
Sponsors
Society of Family Planning
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Women age ≥ 18 * Desire for immediate postpartum IUD or postpartum day #1 after a postplacental IUD placement * English or Spanish speaking * Willing to attend 2 follow-up visits
Exclusion criteria
* Multiple gestations * Delivery prior to 35 weeks gestational age * Allergy or sensitivity to any component of either IUD (including polyethylene, levonorgestrel or copper) * Cesarean delivery * Postpartum hemorrhage (estimated blood loss \> 500 mL) * Chorioamnionitis * Abnormal uterine anatomy (including uterine anomaly or large fibroids) * Treated for Chlamydia or Gonorrhea during pregnancy without a subsequent negative follow-up test * Current cervical cancer or carcinoma in situ * Current breast cancer * Wilson's disease * If enrolling postpartum after IUD has already been placed, women will be excluded if the provider used an insertion technique other than using the ring forceps or the operator's hand
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IUD Expulsion Rate | 3 months postpartum | The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 3 months | A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported. |
| Satisfaction | 3 months | A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of \>= 8 are reported by percent of participants. |
| Pregnancy | 6 weeks | A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated. |
| Intrauterine Device Expulsion (6 Weeks) | 6 weeks | Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound. |
| Intrauterine Device Expulsion by 12 Weeks Postpartum | 12 weeks | Position of the IUD within the uterus will be documented by ultrasound. |
| Intrauterine Device Expulsion (Day 1) | Day 1 | Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound. |
Countries
United States
Participant flow
Recruitment details
This prospective cohort trial was conducted at 2 affiliated teaching hospitals: University of Colorado Hospital (UCH) in Aurora, CO, and Denver Health Medical Center (DHMC) in Denver, CO.
Participants by arm
| Arm | Count |
|---|---|
| Mirena Group Women who have a postplacental Mirena IUD placed. (LNG-IUS)
Mirena: The IUD will be placed as part of standard clinical care. | 68 |
| Paragard Group Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)
Paragard: The IUD will be placed as part of standard clinical care. | 55 |
| Total | 123 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 14 |
Baseline characteristics
| Characteristic | Total | Mirena Group | Paragard Group |
|---|---|---|---|
| Age, Continuous | 26.72 years STANDARD_DEVIATION 5.35 | 26.2 years STANDARD_DEVIATION 5.3 | 27.4 years STANDARD_DEVIATION 5.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 Participants | 26 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 42 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 11 Participants | 10 Participants |
| Race (NIH/OMB) White | 74 Participants | 38 Participants | 36 Participants |
| Region of Enrollment United States | 123 participants | 68 participants | 55 participants |
| Sex: Female, Male Female | 123 Participants | 68 Participants | 55 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 68 | 0 / 55 |
| serious Total, serious adverse events | 0 / 68 | 0 / 55 |
Outcome results
Primary
IUD Expulsion Rate
The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.
Time frame: 3 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mirena Group | IUD Expulsion Rate | 20 Participants |
| Paragard Group | IUD Expulsion Rate | 7 Participants |
Secondary
Complications
A questionnaire will be administered to determine if the participant has had any complications since placement. Number of women reporting complications are reported.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mirena Group | Complications | 0 Participants |
| Paragard Group | Complications | 0 Participants |
Secondary
Intrauterine Device Expulsion (6 Weeks)
Number of expulsions. Position of the IUD within the uterus will be documented by ultrasound.
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirena Group | Intrauterine Device Expulsion (6 Weeks) | 18 participants |
| Paragard Group | Intrauterine Device Expulsion (6 Weeks) | 6 participants |
Secondary
Intrauterine Device Expulsion by 12 Weeks Postpartum
Position of the IUD within the uterus will be documented by ultrasound.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mirena Group | Intrauterine Device Expulsion by 12 Weeks Postpartum | 21 Participants |
| Paragard Group | Intrauterine Device Expulsion by 12 Weeks Postpartum | 8 Participants |
Secondary
Intrauterine Device Expulsion (Day 1)
Number of expulsions at Day 1. Position of the IUD within the uterus will be documented by ultrasound.
Time frame: Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirena Group | Intrauterine Device Expulsion (Day 1) | 0 participants |
| Paragard Group | Intrauterine Device Expulsion (Day 1) | 0 participants |
Secondary
Pregnancy
A urine pregnancy test will be performed at the 3 month follow up visit if clinically indicated.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mirena Group | Pregnancy | 0 Participants |
| Paragard Group | Pregnancy | 0 Participants |
Secondary
Pregnancy
A urine pregnancy test will be performed at the 6 week follow up visit if clinically indicated.
Time frame: 6 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mirena Group | Pregnancy | 0 Participants |
| Paragard Group | Pregnancy | 0 Participants |
Secondary
Satisfaction
A questionnaire will be administered to determine the participant's satisfaction level with the IUD. Satisfaction levels of \>= 8 are reported by percent of participants.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mirena Group | Satisfaction | 91.4 percent of participants |
| Paragard Group | Satisfaction | 94.2 percent of participants |