Early Postpartum Intrauterine Device (IUD) Placement
| Status: | Terminated |
|---|---|
| Conditions: | Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 1/13/2019 |
| Start Date: | March 2012 |
| End Date: | July 2014 |
Early Versus Standard Interval Postpartum Intrauterine Device (IUD) Placement at 3 Weeks or 6 Weeks Following Delivery: A Prospective Randomized Trial
Women who have just given birth are at high risk for rapid repeat pregnancy, which can lead
to negative consequences during the subsequent pregnancy. Providers have traditionally
delayed starting birth control, especially placement of intrauterine devices (IUDs),
post-delivery for a number of reasons. The first postpartum visit after a woman has given
birth is typically scheduled for 6 weeks after her delivery, during which she is typically
provided with her chosen method of birth control. This study will evaluate two different IUD
placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to
determine if placement time affects a woman's follow-through obtaining the IUD and keeping it
inserted in place. The researchers will also look at bleeding patterns and patient/provider
satisfaction with the IUD placement
to negative consequences during the subsequent pregnancy. Providers have traditionally
delayed starting birth control, especially placement of intrauterine devices (IUDs),
post-delivery for a number of reasons. The first postpartum visit after a woman has given
birth is typically scheduled for 6 weeks after her delivery, during which she is typically
provided with her chosen method of birth control. This study will evaluate two different IUD
placement times: 3 weeks and 6 weeks after delivery. This will allow the researchers to
determine if placement time affects a woman's follow-through obtaining the IUD and keeping it
inserted in place. The researchers will also look at bleeding patterns and patient/provider
satisfaction with the IUD placement
The goal of this study is to investigate whether early interval placement of a postpartum IUD
at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater
uptake of the IUD by 3 months after delivery. Many women do not return for a follow up visit.
We will investigate whether they are more likely to return and to receive an IUD if the
follow up visit is earlier. Measures of 6 month IUD continuation, subject acceptability,
safety and efficacy will also be examined. This prospective, randomized, controlled trial
will enroll approximately 240 women at our academic tertiary care hospital in the United
States. Participants will be recruited from women who deliver a live-born singleton infant at
greater than 32 weeks gestation and who have indicated interest in obtaining intrauterine
contraception. Subjects will choose to receive either a levonorgestrel-containing IUS
(Mirena) or copper T380A IUD (ParaGard). Enrolled subjects will be randomized to IUD
placement at either 3 weeks (+/- 3 days) or 6 weeks (+/- 3 days) after their delivery date.
Women will be followed by phone contacts at 3 months and 4 months and will have a clinic
visit with an ultrasound at 6 months after delivery. The IUD position in the uterus and the
uterine size will be assessed at 6 months.
at 3 weeks postpartum, compared to the usual 6 weeks postpartum, is associated with greater
uptake of the IUD by 3 months after delivery. Many women do not return for a follow up visit.
We will investigate whether they are more likely to return and to receive an IUD if the
follow up visit is earlier. Measures of 6 month IUD continuation, subject acceptability,
safety and efficacy will also be examined. This prospective, randomized, controlled trial
will enroll approximately 240 women at our academic tertiary care hospital in the United
States. Participants will be recruited from women who deliver a live-born singleton infant at
greater than 32 weeks gestation and who have indicated interest in obtaining intrauterine
contraception. Subjects will choose to receive either a levonorgestrel-containing IUS
(Mirena) or copper T380A IUD (ParaGard). Enrolled subjects will be randomized to IUD
placement at either 3 weeks (+/- 3 days) or 6 weeks (+/- 3 days) after their delivery date.
Women will be followed by phone contacts at 3 months and 4 months and will have a clinic
visit with an ultrasound at 6 months after delivery. The IUD position in the uterus and the
uterine size will be assessed at 6 months.
Inclusion Criteria:
- Female
- 18 years or older
- Voluntarily requesting either copper T380A or levonorgestrel IUD placement for
postpartum contraception
- Within 5 days of vaginal or cesarean delivery of live born infant ≥32 0/7 weeks at the
time of enrollment
- English or Spanish speaking
- Able to give consent and agree to terms of the study
- No contraindications to use of either intrauterine device
Exclusion Criteria:
- Preterm delivery prior to 32 weeks gestation
- Recent pregnancy with multiple gestation
- Current incarceration
- Known congenital or acquired uterine anomaly, including fibroids that distort the
uterine cavity
- Current or recent pelvic infection (chorioamnionitis treated for fever in labor only
is not an exclusion)
- Suspected hypersensitivity or contraindication to the chosen IUD
- No insurance coverage for postpartum care, including Citizen Alien Waived Emergent
Medical (CAWEM)
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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