Healthy
Conditions
Keywords
Contraception, Contraceptive Devices, Intrauterine Devices, Unplanned Pregnancy, Postpartum Period
Brief summary
The study is a randomized controlled trial comparing outcomes of immediate postplacental insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) vs. interval insertion of the LNG-IUS performed 4-8 weeks after delivery for patients undergoing scheduled cesarean delivery. Our primary hypothesis is that the proportion of women using the LNG-IUS for contraception at 12 months after delivery will be higher in the group randomized to immediate post-placental insertion.
Interventions
DEVICELevonorgestrel-releasing intrauterine system (LNG-IUS)
Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant at time of enrollment * Planning to undergo a scheduled cesarean delivery * Desires to use the LNG-IUS for contraception * Willing and able to sign an informed consent in English * Willing to comply with the study protocol * Age greater than or equal to 18 years * English speaking
Exclusion criteria
* Allergy to either polyethylene or levonorgestrel, or other contraindications to use of the LNG-IUS * Positive testing for Gonorrhea, Chlamydia, or trichomoniasis during the pregnancy without treatment and a subsequent test of cure confirming a negative result * Presence of leiomyomata significantly distorting the uterine cavity and thus not allowing placement of the LNG-IUS * Uterine anomaly which would not allow placement of the LNG-IUS * Current cervical cancer or carcinoma in-situ * Desire for repeat pregnancy in less than 12 months * History of postabortal or postpartum sepsis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Use of the LNG-IUS for Contraception | 12 months after cesarean delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Expulsion of the LNG-IUS | 12 months after cesarean delivery | — |
| Perforation Rates | 12 months after cesarean delivery | — |
| Satisfaction With LNG-IUS | 6 months after cesarean delivery | We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being very unsatisfied, 2 unsatisfied, 3 neutral, 4 satisfied, and 5 very satisfied. For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question. |
Countries
United States
Participant flow
Recruitment details
Location: Two urban academic medical centers from both pre-natal and Labor & Delivery clinics Dates: May 2007-January 2011 Inclusion: Pregnant, English-speaking women, aged 18 years and older, with planned cesarean delivery, and desiring the LNG-IUS were eligible for the study.
Participants by arm
| Arm | Count |
|---|---|
| Delayed Insertion Group Insertion of the LNG-IUS 4-8 weeks after cesarean delivery
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Insertion of the LNG-IUS 4-8 weeks after cesarean delivery | 22 |
| Postplacental Insertion After Cesarean Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta
Device of intervention: Levonorgestrel-releasing intrauterine system (LNG-IUS)
Levonorgestrel-releasing intrauterine system (LNG-IUS) : Immediate postplacental insertion of the LNG-IUS through the uterine incision during cesarean, within 10 minutes after delivery of the placenta | 20 |
| Total | 42 |
Baseline characteristics
| Characteristic | Delayed Insertion Group | Total | Postplacental Insertion After Cesarean |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 42 Participants | 20 Participants |
| Age, Continuous | 28.4 years STANDARD_DEVIATION 5.3 | 27.8 years STANDARD_DEVIATION 5.7 | 27.1 years STANDARD_DEVIATION 6.2 |
| Annual Income <$10,000 | 7 participants | 13 participants | 6 participants |
| Annual Income $10,000-$30,000 | 6 participants | 13 participants | 7 participants |
| Annual Income >$30,000 | 9 participants | 16 participants | 7 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 39 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational Age at Delivery | 38.3 weeks STANDARD_DEVIATION 1.7 | 38.4 weeks STANDARD_DEVIATION 1.6 | 38.4 weeks STANDARD_DEVIATION 1.5 |
| Insurance Coverage Medicaid | 16 participants | 30 participants | 14 participants |
| Insurance Coverage Private | 5 participants | 11 participants | 6 participants |
| Insurance Coverage Unknown/Not given | 1 participants | 1 participants | 0 participants |
| Marital Status Married | 9 participants | 17 participants | 8 participants |
| Marital Status Single | 12 participants | 22 participants | 10 participants |
| Marital Status Single, living with partner | 1 participants | 3 participants | 2 participants |
| Parity at Enrollment 0 | 1 participants | 2 participants | 1 participants |
| Parity at Enrollment 1 | 10 participants | 17 participants | 7 participants |
| Parity at Enrollment 2 | 8 participants | 17 participants | 9 participants |
| Parity at Enrollment 3 or more | 3 participants | 6 participants | 3 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 | 15 Participants | 29 Participants | 14 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 | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment United States | 22 participants | 42 participants | 20 participants |
| Sex: Female, Male Female | 22 Participants | 42 Participants | 20 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 | 2 / 22 | 1 / 20 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 |
Outcome results
Primary
Use of the LNG-IUS for Contraception
Time frame: 12 months after cesarean delivery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Delayed Insertion Group | Use of the LNG-IUS for Contraception | Removed per patient request | 1 participants |
| Delayed Insertion Group | Use of the LNG-IUS for Contraception | Lost to follow up at 12 months | 8 participants |
| Delayed Insertion Group | Use of the LNG-IUS for Contraception | Confirmed use of LNG-IUD | 9 participants |
| Delayed Insertion Group | Use of the LNG-IUS for Contraception | Did not have IUD placed | 4 participants |
| Delayed Insertion Group | Use of the LNG-IUS for Contraception | Expelled prior to 12 months, not replaced | 0 participants |
| Postplacental Insertion After Cesarean | Use of the LNG-IUS for Contraception | Did not have IUD placed | 0 participants |
| Postplacental Insertion After Cesarean | Use of the LNG-IUS for Contraception | Expelled prior to 12 months, not replaced | 2 participants |
| Postplacental Insertion After Cesarean | Use of the LNG-IUS for Contraception | Removed per patient request | 0 participants |
| Postplacental Insertion After Cesarean | Use of the LNG-IUS for Contraception | Confirmed use of LNG-IUD | 12 participants |
| Postplacental Insertion After Cesarean | Use of the LNG-IUS for Contraception | Lost to follow up at 12 months | 6 participants |
p-value: 0.35Fisher Exact
Secondary
Perforation Rates
Time frame: 12 months after cesarean delivery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delayed Insertion Group | Perforation Rates | 0 participants |
| Postplacental Insertion After Cesarean | Perforation Rates | 0 participants |
p-value: 1Fisher Exact
Secondary
Rates of Expulsion of the LNG-IUS
Time frame: 12 months after cesarean delivery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delayed Insertion Group | Rates of Expulsion of the LNG-IUS | 0 participants |
| Postplacental Insertion After Cesarean | Rates of Expulsion of the LNG-IUS | 4 participants |
p-value: 0.04Fisher Exact
Secondary
Satisfaction With LNG-IUS
We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being very unsatisfied, 2 unsatisfied, 3 neutral, 4 satisfied, and 5 very satisfied. For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question.
Time frame: 6 months after cesarean delivery
Population: Analysis only done on subject completing six-month visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delayed Insertion Group | Satisfaction With LNG-IUS | 7 participants |
| Postplacental Insertion After Cesarean | Satisfaction With LNG-IUS | 10 participants |
p-value: 0.37Fisher Exact
Secondary
Satisfaction With LNG-IUS
We measured satisfaction with the IUS at each visit using a single question with a 5 point Likert scale, with 1 being very unsatisfied, 2 unsatisfied, 3 neutral, 4 satisfied, and 5 very satisfied. For statistical purposes, subjects were determined to be SATISFIED with the IUS if they chose either 4 or 5 for this question.
Time frame: 12 months after cesarean delivery
Population: Analysis only done on subjects completing 12-month visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delayed Insertion Group | Satisfaction With LNG-IUS | 9 participants |
| Postplacental Insertion After Cesarean | Satisfaction With LNG-IUS | 11 participants |
p-value: 1Fisher Exact