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

NCT ID: NCT00476021

Last Updated: 2016-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2008-10-31

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.

Detailed Description

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.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Postplacental IUD insertion

immediate postplacental levonorgestrel-releasing IUD (Mirena) insertion

Group Type: EXPERIMENTAL

Levonorgestrel-releasing IUD (Mirena)

Intervention Type: DEVICE

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

Delayed IUD insertion

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

Group Type: ACTIVE_COMPARATOR

Levonorgestrel-releasing IUD (Mirena)

Intervention Type: DEVICE

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

Interventions

Levonorgestrel-releasing IUD (Mirena)

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

Intervention Type: DEVICE

Other Intervention Names

Mirena

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Beatrice Chen

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beatrice A Chen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Magee-Womens Hospital, University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20966692 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22018124 (View on PubMed)

Related Links

http://www.birthcontrolstudies.org

Click here for more information about the Center for Family Planning Research, University of Pittsburgh

Other Identifiers

PRO06070007

Identifier Type: -

Identifier Source: org_study_id