Comparison of the Levonorgestrel IUD and the Copper IUD Placed in the Immediate Postplacental Period: A Prospective Cohort Study

NCT02067663 | Completed Results

• 1 other identifier: 13-3264
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The intrauterine device (IUD) is a safe, highly effective, long acting, and reversible form of contraception. The postpartum period is an important moment for contraceptive intervention; however there are many barriers to women obtaining birth control postpartum. The use of the IUD in the immediate postpartum setting offers many advantages and is considered safe, but the risk of expulsion appears to be higher than with interval insertion. Previous studies have shown the rate of expulsion of the copper IUD in the postplacental period to be in the range of 1-14% by 6-12 months, while the only study of the levonorgestrel IUD in the postplacental period documented a rate of expulsion of 24% by 12 months. While studies related to the copper IUD use ring forceps or the operator's hand for placement of the IUD, the only published study investigating immediate postplacental levonorgestrel IUD insertion utilized the manufacturer's inserter for IUD placement. The investigators therefore ask the question, is there a difference in expulsion rates between levonorgestrel and copper IUDs placed post-placentally when all providers undergo a standardized training, use a standardized insertion technique, and when patient level characteristics are controlled by randomization? The investigators propose to perform a prospective cohort trial comparing the rates of expulsion for the levonorgestrel and the copper IUD by 3 months postpartum when placed in the uterus within 10 minutes of the delivery of the placenta, using a standardized technique (placement with a ring forceps or the operator's hand) after all providers undergo a formal didactic and skills training. The investigators hypothesis is that the levonorgestrel IUD has a higher rate of expulsion as compared to the copper IUD. Additional objectives include a comparison of the rates of complete IUD expulsion, partial IUD expulsion, unrecognized expulsions, complications, IUD continuation, pregnancy, and satisfaction. Additionally, the investigators will document the natural history of the location of the IUD within the uterus when placed in the immediate postpartum period, utilizing ultrasound at 24 hours, 6 weeks, and 3 months postpartum, to better understand the relationship between position of the IUD and subsequent expulsion.

Conditions

Contraception

Keywords

Postplacental IUD placement; LNG-IUS

Outcome Measures

Primary Outcomes (1)

• IUD Expulsion Rate

  The primary outcome of the study is the total number of expulsions in the full 3 month study period. The provider will perform a speculum exam and transvaginal ultrasound. If expulsion has occurred, the participant will have an abdominal x-ray to confirm.

  3 months postpartum

Secondary Outcomes (7)

• Pregnancy

  6 weeks

• Pregnancy

  3 months

• Complications

  3 months

• Satisfaction

  3 months

• Intrauterine Device Expulsion (Day 1)

  Day 1

Study Arms (2)

Mirena Group

Women who have a postplacental Mirena IUD placed. (LNG-IUS)

Drug: Mirena

Paragard Group

Women who have a postplacental Paragard IUD placed. (Copper IUD - T380A)

Device: Paragard

Interventions

Paragard DEVICE

The IUD will be placed as part of standard clinical care.

Also known as: T380A IUD

Paragard Group

Mirena DRUG

The IUD will be placed as part of standard clinical care.

Also known as: LNG-IUS, IUD

Mirena Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women interested in an immediate postpartum IUD, or those who recently had one placed, who are willing to be followed postpartum.

You may qualify if:

• Women age ≥ 18
• Desire for immediate postpartum IUD or postpartum day #1 after a postplacental IUD placement
• English or Spanish speaking
• Willing to attend 2 follow-up visits

You may not qualify if:

• Multiple gestations
• Delivery prior to 35 weeks gestational age
• Allergy or sensitivity to any component of either IUD (including polyethylene, levonorgestrel or copper)
• Cesarean delivery
• Postpartum hemorrhage (estimated blood loss \> 500 mL)
• Chorioamnionitis
• Abnormal uterine anatomy (including uterine anomaly or large fibroids)
• Treated for Chlamydia or Gonorrhea during pregnancy without a subsequent negative follow-up test
• Current cervical cancer or carcinoma in situ
• Current breast cancer
• Wilson's disease
• If enrolling postpartum after IUD has already been placed, women will be excluded if the provider used an insertion technique other than using the ring forceps or the operator's hand

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Society of Family Planning: collaborator

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (32)

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MeSH Terms

Interventions

Levonorgestrel; Intrauterine Devices

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Contraceptive Devices, Female; Contraceptive Devices; Equipment and Supplies

Results Point of Contact

• Title: Lisa Goldthwaite
• Organization: Stanford University School of Medicine

lgoldthw@stanford.edu

541-515-1825

Study Officials

• Stephanie Teal, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2014
• First Posted: February 20, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 5, 2019
• Results First Posted: July 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)