N/A
N=102
Postplacental or Delayed Insertion of the Levonorgestrel-releasing Intrauterine Device (IUD) After Vaginal Delivery
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT00476021 ↗Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Feb 2016
Primary outcome: Primary: IUD Usage Rate at 6 Months — 43; 39 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Levonorgestrel-releasing IUD (Mirena) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IUD Usage Rate at 6 Months |
43; 39 | — |
| SECONDARY Proportion of Women Who Are Able to Have the LNG-IUD Placed Postplacentally and Are Not Excluded From Placement |
50 | — |
| SECONDARY Follow-up Rates for Delayed Insertion of LNG-IUD |
46 | — |
| SECONDARY Expulsion Rates of Post-placental and Delayed Insertion of the LNG-IUD Using Clinical Exam and Ultrasonography |
12; 2 | — |
| SECONDARY Safety of Postplacental Insertion of the LNG-IUD as Measured by Infection Rates |
1; 1 | — |
| SECONDARY Rates of Follow-up and Unintended Pregnancy Rates for Subjects Who Are Excluded From Postpartum Insertion |
2; 11 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00476021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.