Early Postpartum Intrauterine Device (IUD) Placement

NCT ID: NCT01594476

Last Updated: 2019-01-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2014-07-31

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Levonorgestrel IUS insertion at 3 weeks

IUD placement at 3 weeks after delivery.

Group Type: EXPERIMENTAL

Levonorgestrel IUS

Intervention Type: DRUG

20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device

Levonorgestrel IUS insertion at 6 weeks

IUD placement at 6 weeks after delivery.

Group Type: EXPERIMENTAL

Levonorgestrel IUS

Intervention Type: DRUG

20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device

Interventions

Levonorgestrel IUS

20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device

Intervention Type: DRUG

Other Intervention Names

Mirena IUS; Paragard IUD

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Maureen Baldwin

Instructor, Ob/Gyn, Fellow in Family Planning

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maureen Baldwin, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

Baldwin MK, Hart KD, Rodriguez MI. Predictors for follow-up among postpartum patients enrolled in a clinical trial. Contraception. 2018 Sep;98(3):228-231. doi: 10.1016/j.contraception.2018.04.016. Epub 2018 May 8.

Reference Type: DERIVED

PMID: 29750924 (View on PubMed)

Other Identifiers

8120

Identifier Type: -

Identifier Source: org_study_id