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

The United States (US) has the highest unintended pregnancy rate of any developed country.
Of the 6.4 million pregnancies in the US each year, almost half are unintended (49%).
Roughly half of these (22% of all pregnancies) result in unintended births, while 20% of all
pregnancies result in abortion. Postpartum women are particularly susceptible, with an
unintended pregnancy rate of 10%-44% in the first year postpartum. These unintended
pregnancies occur despite the recommendation that a contraceptive method be selected prior
to hospital discharge.

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 IUD is a highly effective but underused method of postpartum
contraception. Although the expulsion rate in postplacental insertion is higher than
interval insertion, the benefits of highly effective contraception available immediately
after delivery may outweigh the risks of expulsion.

To date, there have been no randomized trials of postplacental insertion of the LNG-IUD in
the United States. One pilot study in the United States of 20 subjects who received an
ultrasound-guided postplacental insertion of the LNG-IUD showed an acceptable expulsion rate
of 10% and no infections over a 10-week follow-up, thus making postplacental insertion of
LNG-IUD safe for further study.

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. One hundred sixty-eight women
receiving prenatal care at Magee-Womens Hospital, Pittsburgh, PA, who are interested in
using the LNG-IUD for contraception will be enrolled during their pregnancy. The IUD will be
inserted within 10 minutes after delivery of the placenta in women randomized to immediate
insertion. Delayed IUD insertion will be performed at the first postpartum visit in 6-8
weeks. All subjects will follow up in person at 6-8 weeks and 6 months after delivery. A
telephone interview will occur at 3 months after delivery for all subjects.

Subjects who are not eligible for insertion due to post-randomization ineligibility criteria
will be referred to their primary gynecologist or midwife for delayed IUD placement. They
will be contacted by phone at 3 and 6 months to assess quality of life, contraceptive usage,
and unintended pregnancy rates.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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