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Early Postpartum Intrauterine Device (IUD) Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01594476
Recruitment Status : Terminated (Incomplete study enrollment prior to depletion of funding)
First Posted : May 9, 2012
Results First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Maureen Baldwin, 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

Condition or disease Intervention/treatment Phase
Contraception Drug: Levonorgestrel IUS Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Subjects With an IUD at 3 Months Postpartum [ Time Frame: 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 :
  1. Satisfaction With the Timing of IUD Placement. [ Time Frame: 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.

  2. Uterine Thickness at the Fundus [ Time Frame: 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.

  3. Subjects With an IUD at 6 Months Postpartum [ Time Frame: 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.

  4. Number of Subjects With Adverse Events [ Time Frame: 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.

  5. Pain With IUD Placement [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594476


Locations
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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Society of Family Planning
Investigators
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Principal Investigator: Maureen Baldwin, MD, MPH Oregon Health and Science University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maureen Baldwin, Instructor, Ob/Gyn, Fellow in Family Planning, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01594476    
Other Study ID Numbers: 8120
First Posted: May 9, 2012    Key Record Dates
Results First Posted: January 11, 2019
Last Update Posted: January 11, 2019
Last Verified: January 2019
Keywords provided by Maureen Baldwin, Oregon Health and Science University:
Postpartum
Contraception
Intrauterine device
Intrauterine system
Mirena
Paragard
Uterine involution
Additional relevant MeSH terms:
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Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral