Postpartum Period
Conditions
Keywords
Contraception, Postnatal care
Brief summary
In order to determine the timing of LNG-IUS insertion that results in a greater proportion of women using the LNG-IUS at 6-months post-partum, we will perform a randomized control trial of interval versus immediate post-placenta insertion. Women will be enrolled at 36-weeks gestation and greater. At the time of vaginal delivery, women will be randomized to receive either immediate post-placenta insertion of the LNG-IUS or routine insertion at 4-8 weeks post-partum. All patients will return at 4-6 weeks post-insertion and 6 months post-partum to confirm correct position of the LNG-IUS. The primary outcome of this sub-study is the number of LNG-IUS in the correct position at 6-months. Secondary outcomes include assessing the safety of post-placental LNG-IUS insertion and difference in acceptability and symptoms experienced by participants. This is a sub-study of the Contraceptive Choice Project, a prospective cohort study that aims to improve the use of long-acting contraception by removing financial barriers which has already enrolled over 5,000 patients. Association of this study with CHOICE offers unique advantages including infrastructure to support subject recruitment, retention and completion of follow-up as well as covering the cost of LNG-IUS devices. We hypothesize that, despite higher expulsion rates, women randomized to receive the LNG-IUS immediately after placenta delivery will have higher rates of LNG-IUS continuation due to poor rates of follow up in the interval insertion group. This is likely to be particularly noticeable in our patient population, which is largely uninsured with poor access to healthcare. Further, typical symptoms of LNG-IUS insertion include bleeding and cramping, which may be disguised by the post-partum period. Published reports of immediate post-placenta insertion focus on expulsion rates and do not report on symptoms and satisfaction rates.
Interventions
DEVICEPost-Placenta Mirena Insertion
Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta
DEVICEInterval Insertion
Insertion of Mirena 4-8 weeks post partum after vaginal delivery
Sponsors
Society of Family Planning
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 14-45 years * Vaginal Delivery at Barnes-Jewish Hospital * Sexually active with male partner * No tubal ligation/hysterectomy * Not currently using contraception * Desire reversible contraception * Reside in St. Louis City/County * Requests Mirena(R) intrauterine device for contraception
Exclusion criteria
* Allergy to Mirena(R) system * Cesarean delivery * Cervical cancer, breast cancer * Active liver disease * Untreated cervicitis * Uterine anomaly/fibroids preventing Mirena(R) placement * Delivery \<36 weeks * Chorioamnionitis * Prolonged rupture of membranes (\>18 hours)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mirena in Place | 6 months | Proportion of women in each arm with Mirena in place at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mirena Expulsion | 6 weeks | The percentage of patients with post-placental placement of Mirena who experience an expulsion |
| Uterine Perforation | 6 months | The proportion of patients in each arm who experience a uterine perforation |
| Intrauterine Infection | 6 months | The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease) |
Countries
United States
Participant flow
Pre-assignment details
53 participants were enrolled but only 29 randomized.
Participants by arm
| Arm | Count |
|---|---|
| Interval Insertion 14 subjects received Mirena at 4-8 weeks post-partum after vaginal delivery. | 14 |
| Post-Placental Mirena Insertion 15 received Mirena insertion within 10 minutes of delivery of placenta | 15 |
| Total | 29 |
Baseline characteristics
| Characteristic | Interval Insertion | Post-Placental Mirena Insertion | Total |
|---|---|---|---|
| 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 | 14 Participants | 15 Participants | 29 Participants |
| Age, Continuous | 26.1 years STANDARD_DEVIATION 4.6 | 26.9 years STANDARD_DEVIATION 4.2 | 26.6 years STANDARD_DEVIATION 5.6 |
| Number of pregnancies at viable gestational age | 3 Pregnancies | 6 Pregnancies | 9 Pregnancies |
| Region of Enrollment United States | 14 participants | 15 participants | 29 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 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 / 14 | 0 / 15 |
| serious Total, serious adverse events | 0 / 14 | 1 / 15 |
Outcome results
Primary
Mirena in Place
Proportion of women in each arm with Mirena in place at 6 months
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Placental Mirena Insertion | Mirena in Place | 10 participants |
| Interval Insertion | Mirena in Place | 3 participants |
Secondary
Intrauterine Infection
The proportion of patients in each arm who experience an intrauterine infection (endometritis, pelvic inflammatory disease)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Placental Mirena Insertion | Intrauterine Infection | 0 participants |
| Interval Insertion | Intrauterine Infection | 0 participants |
Secondary
Mirena Expulsion
The percentage of patients with post-placental placement of Mirena who experience an expulsion
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Placental Mirena Insertion | Mirena Expulsion | 0 participants |
| Interval Insertion | Mirena Expulsion | 0 participants |
Secondary
Uterine Perforation
The proportion of patients in each arm who experience a uterine perforation
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Post Placental Mirena Insertion | Uterine Perforation | 0 participants |
| Interval Insertion | Uterine Perforation | 0 participants |