Immediate Postplacental IUD Insertion

NCT ID: NCT02169869

Last Updated: 2019-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2017-06-30

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.

Conditions

Contraception

Study Design

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

Study Groups

Immediate postplacental IUD insertion

Women randomized to the immediate postplacental IUD group will receive their IUD within 60 minutes of placental delivery.

Group Type: EXPERIMENTAL

Mirena

Intervention Type: DEVICE

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.

Paragard

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Mirena

Intervention Type: DEVICE

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.

Paragard

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

levonorgestrel intrauterine system; Copper T380A IUD

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Society of Family Planning

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey Jensen

Research Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

OHSU IRB #10473

Identifier Type: -

Identifier Source: org_study_id