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

This study has been completed.
Sponsor:
Collaborator:
Anonymous
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00476021
First received: May 17, 2007
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Contraception
Device: Levonorgestrel-releasing IUD (Mirena)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device After Vaginal Delivery

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Usage rate of the LNG-IUD at 6 months after delivery [ Time Frame: 6 months after delivery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of women who are able to have the LNG-IUD placed postplacentally and are not excluded from placement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Follow-up rates for delayed insertion of LNG-IUD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Expulsion rates of post-placental and delayed insertion of the LNG-IUD using clinical exam and ultrasonography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Safety of postplacental insertion of the LNG-IUD as measured by infection rates and perforation rates [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Acceptability and quality of life following LNG-IUD placement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Utility of ultrasound in predicting expulsion rates after postplacental and delayed insertion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Rates of follow-up and unintended pregnancy rates for subjects who are excluded from postpartum insertion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Attitudes towards perceived risk of pregnancy, pregnancy intention, and contraceptive methods in women who do not undergo postplacental or delayed IUD insertion compared with women who do undergo IUD insertion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: May 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
immediate postplacental IUD insertion
Device: Levonorgestrel-releasing IUD (Mirena)
levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years
Other Name: Mirena
Active Comparator: 2
delayed IUD insertion (6-8 weeks after delivery)
Device: Levonorgestrel-releasing IUD (Mirena)
levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years
Other Name: Mirena

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476021

Locations
United States, Pennsylvania
Magee-Womens Hospital, University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Anonymous
Investigators
Principal Investigator: Beatrice A Chen, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beatrice A. Chen, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00476021     History of Changes
Other Study ID Numbers: PRO06070007
Study First Received: May 17, 2007
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
postpartum
contraception
postplacental IUD
intrauterine devices

Additional relevant MeSH terms:
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral

ClinicalTrials.gov processed this record on April 17, 2014