Early Postpartum Intrauterine Device (IUD) Placement

Phase 4

Terminated

Conditions: Contraception

Interventions: Drug: Levonorgestrel IUS

Registration Number: NCT01594476

Lead Sponsor: Oregon Health and Science University

Brief Summary: 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

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 201

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levonorgestrel IUS insertion at 3 weeks	Levonorgestrel IUS	IUD placement at 3 weeks after delivery.
Levonorgestrel IUS insertion at 6 weeks	Levonorgestrel IUS	IUD placement at 6 weeks after delivery.

Primary Outcome Measures

Name	Time	Method
Subjects With an IUD at 3 Months Postpartum	Three months after delivery	Subjects will be contacted by phone or email at 3 months after delivery. We will compare the proportion of subjects who report having an IUD in place at 3 months after delivery of those who are randomized to each group (placement at either 3 weeks or 6 weeks) .

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events	Six months after delivery	Subjects will be followed for 6 months each. Over the 6 month study period, the number and proportion of subjects who experience adverse events including treatment for infection, IUD expulsion or IUD perforation will be assessed.
Satisfaction With the Timing of IUD Placement.	Immediately following IUD placement.	Subjects were asked to record their overall satisfaction with the timing of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "very dissatisfied" and "very satisfied." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher satisfaction.
Uterine Thickness at the Fundus	At IUD placement	Transvaginal ultrasound will be performed immediately following IUD placement. The thickness of the uterine myometrium at the fundus from the endometrium to the outer edge of the serosa will be measured in centimeters using an ultrasound caliper in the sagittal view.
Subjects With an IUD at 6 Months Postpartum	Six months after delivery	Subjects will return to clinic for an ultrasound and exam at six months after delivery. We will compare the proportion of subjects with an IUD at this time of those randomized to each placement timing.
Pain With IUD Placement	At the time of IUD placement.	Subjects were asked to record their current pain immediate at the time of the IUD placement on a 100 millimeter (mm) visual analog scale (VAS). A VAS is a 100 mm horizontal line with anchors stating "no pain" and "worst pain in my life." The VAS score is calculated by measuring the distance in millimeters between the left end of the scale and the intersection of a vertical mark placed by the subject. Maximum score is 100 (range 0-100). Higher scores indicate higher pain. The distance from the left side of the 10 cm line to the mark will be measured in millimeters and compared between randomization groups if they received an IUD at the allocated timing of 18-24 or 39-45 days.