Postplacental Mirena IUD Insertion and Estimating Expulsion Rates.

• Sponsor: Rebecca Hunt (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01230242
• Collaborator: MaineHealth (Other)
• Enrollment: 4
• Arm: 1
• Actual Duration (Months): 10.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Estimating Rates of Expulsion	Device: Levonorgestrel Intrauterine Device	N/A

Detailed Description

The average expulsion rate for 6 week postpartum IUD insertion is approximately 10-12% with a range between 3-20% at 1 year. An acceptable expulsion rate for postplacental insertion (PPI) has not been defined and varies between studies. There are limited data on the expulsion rates of levonorgestrel intrauterine systems. Expulsion rates range widely from 1-3% to as high as 30-40% depending on the IUD and the study. Studies report an average rate of expulsion in ranges approximating 10-12%, similar to 6 week insertion rates.

There are many limitations to published studies including the use of older model IUDs no longer in use, multiple insertion techniques that have been deemed ineffective in reducing expulsion rates as well as varying follow up times making comparison of expulsion rates difficult.

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Mirena IUD placementMirena IUD placement
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Experimental Study Examining Mirena IUD Insertion and Estimating Rates of Expulsion Immediately After Placental Delivery.
• Actual Study Start Date: Sep 7, 2010
• Actual Primary Completion Date: Oct 27, 2010
• Actual Study Completion Date: Jul 26, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mirena IUD Placement Immediately Post-delivery Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks.	Device: Levonorgestrel Intrauterine Device; levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol; Other Names: Mirena

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Expelled IUDs by12 Weeks Postpartum [up to 12 weeks postpartum]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• age 18 or greater

• obstetric patient in greater Portland, ME area

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Rebecca Hunt
• MaineHealth

Investigators

• Principal Investigator: Jennifer J Mueller, MD, MaineHealth

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rebecca Hunt, Physician, MMP Women's Health Maternal-Fetal Medicine, MaineHealth
• ClinicalTrials.gov Identifier: NCT01230242
• Other Study ID Numbers: 3689
• First Posted: Oct 29, 2010
• Last Update Posted: Dec 17, 2021
• Last Verified: Dec 1, 2021

• Keywords provided by Rebecca Hunt, Physician, MMP Women's Health Maternal-Fetal Medicine, MaineHealth: Mirena; postplacental intrauterine device; postpartum insertion
• Additional relevant MeSH terms: Levonorgestrel

Study Results

Participant Flow

Pre-assignment Detail	Only 4 subjects were consented out of the 20. Of those 4 only 3 had the IUD inserted.

Arm/Group Title	Mirena IUD Placement Immediately Post-delivery
Arm/Group Description	Subjects to have Mirena IUD Placement Immediately Post-delivery
Period Title: Overall Study
STARTED	4
COMPLETED	1
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Mirena IUD Placement Immediately Post-delivery
Arm/Group Description	Subjects to have Mirena IUD Placement Immediately Post-delivery
Overall Participants	4
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Expelled IUDs by12 Weeks Postpartum
Description	Number of participants who expelled IUDs by12 weeks postpartum across all participants
Time Frame	up to 12 weeks postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mirena IUD Placement Immediately Post-delivery
Arm/Group Description	Participants enrolling in this study agree to have the IUD placed immediately post-delivery versus waiting the standard 6 weeks. Levonorgestrel Intrauterine Device: levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol
Measure Participants	4
Count of Participants [Participants]	1 25%

Adverse Events

Time Frame	12 weeks post IUD placement
Arm/Group Title	Mirena IUD Placement Immediately Post-delivery
Arm/Group Description	Subjects to have Mirena IUD Placement Immediately Post-delivery
All Cause Mortality
	Mirena IUD Placement Immediately Post-delivery
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Serious Adverse Events
	Mirena IUD Placement Immediately Post-delivery
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	Mirena IUD Placement Immediately Post-delivery
	Affected / at Risk (%)	# Events
Total	0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.