Early Postpartum Intrauterine Device (IUD) Placement

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Oregon Health and Science University
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Maureen Baldwin, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01594476
First received: March 9, 2012
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Contraception
Drug: Levonorgestrel IUS
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Versus Standard Interval Postpartum Intrauterine Device (IUD) Placement at 3 Weeks or 6 Weeks Following Delivery: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Proportion of subjects with an IUD at 3 months postpartum [ Time Frame: Three months after delivery ] [ Designated as safety issue: No ]
    Subjects will be contacted by phone or email at 3 months after delivery. The proportion of women who are randomized to each group (placement at either 3 weeks or 6 weeks) who report having an IUD in place at 3 months after delivery will be compared.


Secondary Outcome Measures:
  • Satisfaction with the timing of IUD placement. [ Time Frame: Immediately following IUD placement and at 3 months, 4 months and 6 months after delivery. ] [ Designated as safety issue: No ]
    Subjects will be asked to record their overall satisfaction with the timing of the IUD placement on a continuous 10 cm visual analog scale (VAS). The mean score in millimeters, as measured from the left end of the scale to a vertical hash mark placed on the 10 cm line by the subject, will be compared between the two randomization groups.

  • Uterine thickness at the fundus [ Time Frame: At IUD placement and at 6 months after delivery ] [ Designated as safety issue: No ]
    Transvaginal ultrasound will be performed immediately following IUD placement and at 6 months after delivery. The thickness of the uterine myometrium at the fundus from the endometrium to the outer edge of the serosa will be measured in millimeters using an ultrasound caliper in the sagittal view. Other ultrasound measurements will be performed and compared between randomization groups including uterine width, cavity length, and the IUD-fundal distance. Details about breastfeeding and return of menses will be assessed as covariates.

  • Proportion of subjects with an IUD at 6 months postpartum [ Time Frame: Six months after delivery ] [ Designated as safety issue: No ]
    Subjects will return to clinic for an ultrasound and exam at six months after delivery. The proportion of subjects with an IUD at this time will be compared between the two randomization groups.

  • Number of subjects with adverse events [ Time Frame: Six months after delivery ] [ Designated as safety issue: Yes ]
    Subjects will be followed for 6 months each. Over the proposed 18 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.

  • Pain with IUD placement [ Time Frame: At the time of IUD placement. ] [ Designated as safety issue: No ]
    Subjects will draw a vertical hash mark on a 10 cm visual analog scale (VAS) at the time of IUD placement to indicate their current 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. Baseline pain and pain at other time points will be assessed as well to be used for comparison.


Estimated Enrollment: 240
Study Start Date: March 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levonorgestrel IUS insertion at 3 weeks
IUD placement at 3 weeks after delivery.
Drug: Levonorgestrel IUS
20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
Other Names:
  • Mirena IUS
  • Paragard IUD
Experimental: Levonorgestrel IUS insertion at 6 weeks
IUD placement at 6 weeks after delivery.
Drug: Levonorgestrel IUS
20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
Other Names:
  • Mirena IUS
  • Paragard IUD

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594476

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Maureen K Baldwin, MD, MPH    503-494-9762    schaum@ohsu.edu   
Principal Investigator: Maureen K Baldwin, MD, MPH         
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning
Investigators
Principal Investigator: Maureen Baldwin, MD, MPH Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Maureen Baldwin, Instructor, Ob/Gyn, Fellow in Family Planning, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01594476     History of Changes
Other Study ID Numbers: 8120
Study First Received: March 9, 2012
Last Updated: November 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Postpartum
Contraception
Intrauterine device
Intrauterine system
Mirena
Paragard
Uterine involution

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on August 25, 2014