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Immediate Postplacental IUD Insertion

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: NCT02169869
Recruitment Status : Terminated (Change in local healthcare policies and practices)
First Posted : June 23, 2014
Results First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Jeffrey Jensen, Oregon Health and Science University

Brief Summary:

The study will be a randomized clinical trial. Women with less than 10 prenatal visits and/or 2 or more no show visits who desire an Intrauterine Device (IUD) will be considered for enrollment. If consented and meet inclusion criteria, they will be randomized after delivery to receive an IUD immediately postplacental or at their routine postpartum visit.

Women who plan to deliver a live birth singleton via vaginal or cesarean delivery at Oregon Health and Science University (OHSU) hospital will be considered for inclusion in the study. Women who desire an IUD for postpartum contraception will be approached for study participation. The postpartum contraception plan is routinely documented during their prenatal course. It is also addressed by the obstetrical team upon admission to Labor & Delivery at OHSU. The obstetrical team will identify subjects who present in labor who meet the criteria of poor prenatal clinic attendance and express interest in intrauterine contraception. Immediately after vaginal or cesarean delivery, consented subjects will be randomized to immediate postplacental IUD placement or IUD placement at their routine postpartum visit. Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery. Prior to discharge from the hospital women who received a postplacental IUD will be assisted in scheduling a routine postpartum visit with their primary provider. Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider. All subjects in the delayed group will be provided with contact information for the Women's Health Research Unit (WHRU) at OHSU. If a subject cannot obtain an IUD at her usual place of care, the device will be placed at no cost through the WHRU.

At 3 months after delivery, all subjects will be contacted by phone, text, or email to complete a questionnaire to determine whether they have had a known expulsion, pregnancy, or elective IUD removal. The questionnaire will include questions regarding ease of placement and overall satisfaction with the timing of placement. Subjects will be compensated for their participation in the study after the 3 month contact.


Condition or disease Intervention/treatment Phase
Contraception Device: Mirena Device: Paragard Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized-controlled trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Immediate Postplacental Intrauterine Device Insertion in High-risk Patient Populations
Study Start Date : September 2014
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate postplacental IUD insertion
Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.
Device: Mirena
A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Other Name: levonorgestrel intrauterine system

Device: Paragard
A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
Other Name: Copper T380A IUD

Active Comparator: 6 weeks postpartum IUD insertion
Subjects who are randomized for IUD insertion at their postpartum visit will be assisted in scheduling a postpartum visit and IUD placement with their usual obstetrical care provider.
Device: Mirena
A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Other Name: levonorgestrel intrauterine system

Device: Paragard
A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
Other Name: Copper T380A IUD




Primary Outcome Measures :
  1. Proportion of Subjects With an IUD at 3 Months Postpartum [ Time Frame: 3 months postpartum (after delivery) ]
    Subjects were contacted at 3 months after delivery. Comparison of the proportion of women randomized to placement of IUD within 60 minutes of placental delivery or at their 6-week routine postpartum visit who report having an IUD in place at 3 months after delivery.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • 18 yo or older
  • Singleton pregnancy at ≥32 weeks gestation at time of enrollment
  • Voluntarily requesting either copper T380A or levonorgestrel IUD (LNG-IUS) placement for postpartum contraception
  • English or Spanish speaking
  • Able to give consent and agree to the terms of the study
  • Less than 10 prenatal visits or 2 or more no show visits
  • Since IUDs are not on our hospital formulary, the patient must qualify for a Long Acting Reversible Contraceptive (LARC) IUD (this includes all Oregon Health Plan (OHP) or Citizen/Alien Waived Emergent Medical (CAWEM) insured patients or women with income <300% of the federal poverty line).

Exclusion Criteria:

  • Anatomic uterine abnormalities that prevent proper fundal placement of IUD (obstructive myomata, bicornuate, septate, etc)
  • Chorioamnionitis (also consider other risk factors such as prolonged rupture of membranes >18 hours, prolonged labor >24 hours, fever >38C)
  • Puerperal sepsis
  • Unresolved postpartum hemorrhage
  • Extensive genital trauma
  • Current incarceration
  • Known or suspected untreated endocervical gonorrhea, chlamydia
  • Wilson's disease, copper allergy (Paragard only)
  • Known or suspected cervical or endometrial cancer or pelvic tuberculosis
  • Current breast cancer (LNG-IUS only)
  • Systemic lupus erythematosus (SLE) with severe thrombocytopenia (Paragard only)
  • Trophoblastic disease (benign or malignant)
  • AIDS not stable on antiretroviral

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): NCT02169869


Locations
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United States, Oregon
Oregon Health and 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: Jeffrey Jensen, MD Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Jeffrey Jensen, Oregon Health and Science University:
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Responsible Party: Jeffrey Jensen, Research Director, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02169869    
Other Study ID Numbers: OHSU IRB #10473
First Posted: June 23, 2014    Key Record Dates
Results First Posted: May 1, 2019
Last Update Posted: May 1, 2019
Last Verified: April 2019
Keywords provided by Jeffrey Jensen, Oregon Health and Science University:
intrauterine device, postpartum, contraception, Mirena, Paragard, intrauterine system
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