Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement
| Status: | Terminated |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 15 - 45 |
| Updated: | 9/27/2018 |
| Start Date: | July 2009 |
| End Date: | July 2012 |
Safety and Expulsion of Delayed Versus Immediate Postpartum Intrauterine Device Placement: A Randomized, Controlled Trial
This is randomized controlled trial designed for pregnant women who deliver vaginally at the
University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted
for postpartum contraception. After informed consent is obtained, eligible study participants
will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10
minutes of delivery of the placenta following a normal vaginal delivery. The investigators
seek to determine the expulsion rate and complication rate in subjects with IUD immediately
after placental delivery compared to insertion at six weeks postpartum or later. The
investigators hypothesize that immediate placement safe and has an acceptably low expulsion
rate to merit earlier placement in the indigent population.
University of Louisville Hospital and desire to have an intrauterine device (IUD) inserted
for postpartum contraception. After informed consent is obtained, eligible study participants
will be randomized to receive the Mirena® IUD at the 6 week postpartum visit or within 10
minutes of delivery of the placenta following a normal vaginal delivery. The investigators
seek to determine the expulsion rate and complication rate in subjects with IUD immediately
after placental delivery compared to insertion at six weeks postpartum or later. The
investigators hypothesize that immediate placement safe and has an acceptably low expulsion
rate to merit earlier placement in the indigent population.
Unintended pregnancy occurs in nearly half of all pregnancies in the United States. There are
many barriers to implementation of long-term reversible contraception in the immediate
postpartum period. In our indigent population, a survey of patients showed that nearly 60% of
patients who chose an IUD while admitted postpartum never returned for placement, placing
them at risk for early repeat pregnancy.
The intrauterine device is a safe and effective form of long-term reversible contraception
when placed at 6 weeks postpartum or later with pregnancy rates of only 0.1%. The
commercially available Mirena IUD contains levonorgestrel which is released slowly over five
years, providing safe, reversible contraception and making menstrual flow much lighter.
This randomized controlled trial will compare traditional placement at 6 weeks or more
postpartum versus immediate post-placental placement.
The investigators hypothesize that the expulsion rate of IUDs placed immediately postpartum
will be acceptably low in an indigent population to still be cost effective. Studies from the
world literature in Egypt and Mexico where IUDs are routinely placed immediately following
placental delivery.support this hypothesis. A recent study published in 2010 by Chen et al.
showed an approximately 24% expulsion rate.
Six week postpartum IUD placement for contraception will be compared to immediate
post-placental IUD placement, to determine whether immediate IUD insertion after delivery has
an acceptably low rate of expulsion, infection, perforation and unintended pregnancy, and a
high rate of retention, patient satisfaction, and maintenance of contraception.
many barriers to implementation of long-term reversible contraception in the immediate
postpartum period. In our indigent population, a survey of patients showed that nearly 60% of
patients who chose an IUD while admitted postpartum never returned for placement, placing
them at risk for early repeat pregnancy.
The intrauterine device is a safe and effective form of long-term reversible contraception
when placed at 6 weeks postpartum or later with pregnancy rates of only 0.1%. The
commercially available Mirena IUD contains levonorgestrel which is released slowly over five
years, providing safe, reversible contraception and making menstrual flow much lighter.
This randomized controlled trial will compare traditional placement at 6 weeks or more
postpartum versus immediate post-placental placement.
The investigators hypothesize that the expulsion rate of IUDs placed immediately postpartum
will be acceptably low in an indigent population to still be cost effective. Studies from the
world literature in Egypt and Mexico where IUDs are routinely placed immediately following
placental delivery.support this hypothesis. A recent study published in 2010 by Chen et al.
showed an approximately 24% expulsion rate.
Six week postpartum IUD placement for contraception will be compared to immediate
post-placental IUD placement, to determine whether immediate IUD insertion after delivery has
an acceptably low rate of expulsion, infection, perforation and unintended pregnancy, and a
high rate of retention, patient satisfaction, and maintenance of contraception.
Inclusion Criteria:
1. Patients must be 15- 45 years of age and received their prenatal care at the
University of Louisville OB/GYN clinic
2. Planned vaginal delivery
3. Negative third trimester cultures for Gonorrhea and Chlamydia
4. Desire to use the IUD for contraception
Exclusion Criteria:
1. Uterine anomalies
2. Uterine or cervical neoplasia
3. Past or current breast cancer
4. Chorioamnionitis
5. Acute liver disease
6. Postpartum hemorrhage lasting greater than ten minutes or more than 500 mL blood loss
7. Received prenatal other than at the University of Louisville OB/GYN Clinic
8. Cesarean section
We found this trial at
1
site
University of Louisville The University of Louisville is a state supported research university located in...
Click here to add this to my saved trials
