Unplanned Pregnancy
Conditions
Keywords
levonorgestrel releasing intrauterine device, levonorgestrel releasing intrauterine contraception, unintended pregnancy prevention, postpartum contraception
Brief summary
This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months. The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.
Detailed description
This was a single arm cohort study of women who desired to receive a levonorgestrel releasing intrauterine system (LNG-IUS) within 48 hours of uncomplicated vaginal delivery. Women were enrolled during a prenatal care visit when they reported they desired to use the LNG-IUS after the birth of their infant. Forty women stated enrolled in the study prior to labor, and baseline data were obtained. After delivery 29 women remained both interested in the study and were still eligible to receive the LNG-IUS prior to discharge from the hospital. Of the 29 women who received the LNG-IUS prior to discharge from the hospital 11 women had an LNG-IUS expulsion prior to 6 months postpartum.
Interventions
DRUGLevonorgestrel-Releasing Intrauterine Contraceptive System (LNG-IUS), 52 Mg, 5 Year Duration
Levonorgestrel-Releasing Intrauterine Contraceptive System, 52 Mg, 5 Year Duration Postpartum placement of LNG-IUS within 10 minutes - 48 hours
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia. * Desires to use intrauterine contraception (IUD) after delivery * Anticipates having a vaginal delivery * No intention to leave the area 7 months after enrollment * Able to consent to participate in the study in English * Has no known uterine anomalies * Has no allergies to any components of the intrauterine contraception
Exclusion criteria
* Prior cesarean delivery * Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy * Allergic to betadine * Allergy to lidocaine * Medical or personal conditions which in the judgment of study staff contradict participation in the study * Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ * After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following: * Endometritis or chorioamnionitis during the intrapartum period * Membranes ruptured for greater than 24 hours prior to delivery * Fever greater than or equal to 38C * The need to use additional medications other than pitocin and/or misoprostol to control postpartum bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IUD Expulsion | From time of insertion to final study date which is 6 months after IUD insertion. | Expulsion of the LNG-IUS |
Countries
United States
Participant flow
Pre-assignment details
All women enrolled who stated they wanted an IUD postpartum. Of those 40 enrolled, 29 were eligible, and did receive, the IUD prior to discharge from the hospital.
Participants by arm
| Arm | Count |
|---|---|
| Immediate Insertion Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.
Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Immediate Insertion |
|---|---|
| Age, Continuous | 23 years |
| Previous contraceptive use, marital status, employment, Employed No | 27 Participants |
| Previous contraceptive use, marital status, employment, Employed Yes | 2 Participants |
| Previous contraceptive use, marital status, employment, Married or Cohabitating No | 20 Participants |
| Previous contraceptive use, marital status, employment, Married or Cohabitating Yes | 9 Participants |
| Previous contraceptive use, marital status, employment, Prior use of contraception No | 0 Participants |
| Previous contraceptive use, marital status, employment, Prior use of contraception Yes | 29 Participants |
| Race/Ethnicity, Customized Race Black | 9 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants |
| Race/Ethnicity, Customized Race White | 17 Participants |
| Region of Enrollment United States | 29 Participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 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 / 29 | 0 / 11 |
| serious Total, serious adverse events | 0 / 29 | 0 / 11 |
Outcome results
Primary
IUD Expulsion
Expulsion of the LNG-IUS
Time frame: From time of insertion to final study date which is 6 months after IUD insertion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate Insertion | IUD Expulsion | 11 Participants |