NCT00476021

Brief Summary

This study is a randomized controlled trial comparing 6 month usage rates of the levonorgestrel-releasing intrauterine device (LNG-IUD) when inserted postplacentally after vaginal delivery or delayed placement at 6-8 weeks postpartum. Given the high rate of unintended pregnancy in the United States, particularly in postpartum women, there is a need for reliable, effective, long-term contraception such as the IUD in postpartum women. Postplacental insertion of intrauterine contraception would help to address this need. The primary hypothesis of this study is that use of the LNG-IUD at 6 months after vaginal delivery will be higher in women who have immediate postplacental insertion as compared to delayed insertion 6-8 weeks following delivery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
7.4 years until next milestone

Results Posted

Study results publicly available

February 19, 2016

Completed
Last Updated

June 24, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

May 17, 2007

Results QC Date

December 1, 2014

Last Update Submit

May 17, 2016

Conditions

Contraception

Keywords

postpartumcontraceptionpostplacental IUDintrauterine devices

Outcome Measures

Primary Outcomes (1)

  • IUD Usage Rate at 6 Months

    Usage rate of the LNG-IUD at 6 months after delivery

    6 months after delivery

Secondary Outcomes (5)

  • Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement

    6 months

  • Follow-up Rates for Delayed Insertion of LNG-IUD

    6 months

  • Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography

    6 months

  • Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates

    6 months

  • Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion

    6 months

Study Arms (2)

Postplacental IUD insertion

EXPERIMENTAL

immediate postplacental levonorgestrel-releasing IUD (Mirena) insertion

Device: Levonorgestrel-releasing IUD (Mirena)

Delayed IUD insertion

ACTIVE COMPARATOR

delayed levonorgestrel-releasing IUD (Mirena) insertion (6-8 weeks after delivery)

Device: Levonorgestrel-releasing IUD (Mirena)

Interventions

Levonorgestrel-releasing IUD (Mirena)DEVICE

levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years

Also known as: Mirena
Delayed IUD insertionPostplacental IUD insertion

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater than or equal to 18 years
  • Greater than or equal to 24 0/7 weeks pregnant at time of enrollment
  • Anticipates undergoing a vaginal delivery
  • Desires to use the LNG-IUD (Mirena) for postpartum contraception
  • Willing and able to sign an informed consent in English
  • Willing to comply with the study protocol

You may not qualify if:

  • Planning to undergo a scheduled cesarean section
  • Allergy to either polyethylene or levonorgestrel or other contraindications to use of the LNG-IUD
  • Exposure to or treatment for gonorrhea, chlamydia, or trichomoniasis during the pregnancy
  • Presence of one or more leiomyomata greater than 3 centimeters in diameter
  • Uterine anomaly (other than a repaired septate uterus)
  • Current cervical cancer or carcinoma in-situ
  • Desires repeat pregnancy within one year of delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee-Womens Hospital, University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.

    PMID: 20966692RESULT

  • Chen BA, Reeves MF, Creinin MD, Schwarz EB. Postplacental or delayed levonorgestrel intrauterine device insertion and breast-feeding duration. Contraception. 2011 Nov;84(5):499-504. doi: 10.1016/j.contraception.2011.01.022. Epub 2011 Apr 16.

    PMID: 22018124RESULT

Related Links

Results Point of Contact

Title
Principal Investigator
Organization
University of Pittsburgh
chenba@upmc.edu
412-641-5496

Study Officials

  • Beatrice A Chen, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 17, 2007

First Posted

May 21, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

June 24, 2016

Results First Posted

February 19, 2016

Record last verified: 2016-05

Locations

US(1)