Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device (IUD) After Vaginal Delivery

Completed · Not applicable

Conditions studied: Contraception

In brief

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.

Key facts

Study ID

NCT00476021

Run by

University of Pittsburgh

People needed

168

Starts

2007-05-01

Expected to finish

2008-10-01

Last updated by the study team

2016-06-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• Magee-Womens Hospital, University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.