Cesarean Section, Intrauterine Devices
Conditions
Keywords
Postpartum Contraception, Intrauterine Devices
Brief summary
This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.
Interventions
DEVICEImmediate Postplacental Placement of an IUD during cesarean delivery
Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
Sponsors
Society of Family Planning
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women ages 18-45 * Pregnant and greater than or equal to 24 weeks of estimated gestational age * Live Pregnancy * States a plan to use an Intrauterine Device (IUD) postpartum for contraception * Plan for cesarean delivery * Intend to stay in the Chapel Hill area for at least 6 months after birth * Fluent in English or Spanish
Exclusion criteria
* known uterine anomalies * allergies to any component of the IUD of their choosing * known or suspected carcinoma of the breast * known acute liver disease or liver tumor (benign or malignant) * known or suspected uterine or cervical neoplasia * active pelvic inflammatory disease * genital bleeding of unknown etiology * history of solid organ transplantation * positive test for gonorrhea or chlamydia during this pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IUD Use | 6 months postpartum | The use of an IUD at 6 months postpartum is the primary outcome measure |
Secondary
| Measure | Time frame |
|---|---|
| IUD Expulsion | 0-6 months postpartum |
| Women's Satisfaction With IUDs | 0-6 months postpartum |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interval IUD Placement Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery | 56 |
| Immediate Postplacental IUD Placement Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta
Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta | 56 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 8 |
Baseline characteristics
| Characteristic | Interval IUD Placement | Immediate Postplacental IUD Placement | Total |
|---|---|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 0.51 | 28 years STANDARD_DEVIATION 0.57 | 28 years STANDARD_DEVIATION 0.51 |
| Race/Ethnicity, Customized Asian | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized Black | 15 participants | 13 participants | 28 participants |
| Race/Ethnicity, Customized Hispanic | 18 participants | 13 participants | 31 participants |
| Race/Ethnicity, Customized Other | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized White | 22 participants | 26 participants | 48 participants |
| Sex: Female, Male Female | 56 Participants | 56 Participants | 112 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 | 1 / 56 | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 | 0 / 56 |
Outcome results
Primary
IUD Use
The use of an IUD at 6 months postpartum is the primary outcome measure
Time frame: 6 months postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interval IUD Placement | IUD Use | 32 participants |
| Immediate Postplacental IUD Placement | IUD Use | 40 participants |
Secondary
IUD Expulsion
Time frame: 0-6 months postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interval IUD Placement | IUD Expulsion | 1 participants |
| Immediate Postplacental IUD Placement | IUD Expulsion | 4 participants |
Secondary
Women's Satisfaction With IUDs
Time frame: 0-6 months postpartum
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interval IUD Placement | Women's Satisfaction With IUDs | 92 percentage of participants satisfied |
| Immediate Postplacental IUD Placement | Women's Satisfaction With IUDs | 100 percentage of participants satisfied |