Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

NCT01230242 | Terminated Results DMC

• 1 other identifier: 3689
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to demonstrate that the expulsion rate is increased but acceptable when inserting Mirena IUDs immediately postpartum, termed 'postplacental IUD insertion'. The investigators will compare the postplacental insertion expulsion rate estimate with rates reported in the literature for 6 week postpartum insertion, which is currently the American standard for IUD insertion postpartum. Secondary outcomes will also be examined; endometritis, uterine perforation, continuation and pregnancy among others.

Conditions

Estimating Rates of Expulsion

Keywords

Mirena; postplacental intrauterine device; postpartum insertion

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Expelled IUDs by12 Weeks Postpartum

  Number of participants who expelled IUDs by12 weeks postpartum across all participants

  up to 12 weeks postpartum

Study Arms (1)

Mirena IUD Placement Immediately Post-delivery

EXPERIMENTAL

Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks.

Device: Levonorgestrel Intrauterine Device

Interventions

Levonorgestrel Intrauterine Device DEVICE

levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol

Also known as: Mirena

Mirena IUD Placement Immediately Post-delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or greater
• obstetric patient in greater Portland, ME area

You may not qualify if:

• Evidence of chorioamnionitis (persistent fetal tachycardia, intra-partum fever \>38.0)
• prolonged rupture of membranes (greater than 24 hours)
• intrauterine fetal demise
• use of general anesthesia at time of delivery
• postpartum hemorrhage (\>500ml vaginal, \>1000ml cesarean)
• magnesium administration in labor due to HELLP syndrome or preeclampsia
• preterm delivery.

Sponsors & Collaborators

• Rebecca Hunt: lead
• MaineHealth: collaborator

Results Point of Contact

• Title: Clinicaltrials.gov Administrator
• Organization: MaineHealth

llemire@mmc.org

207.396.8228

Study Officials

• Jennifer J Mueller, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician, MMP Women's Health Maternal-Fetal Medicine

Model Details: Mirena IUD placement

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: October 29, 2010
• Study Start: September 7, 2010
• Primary Completion: October 27, 2010
• Study Completion: July 26, 2011
• Last Updated: December 17, 2021
• Results First Posted: December 17, 2021

Record last verified: 2021-12