NCT02706340

Expulsion of Immediate Postplacental Copper Intrauterine Devices at Six Months: A Prospective Cohort Study

Expulsion of Immediate Postplacental Copper Intrauterine Devices at Six Months: A Prospective Cohort Study (PPIUD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 309 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational study enrolling women who have had a copper intrauterine device placed immediately after childbirth. The study follows participants for 6 month in order to evaluate the primary outcome of IUD expulsion within 6 months of delivery.

Detailed description

The purpose of the study is to measure the rate of expulsion of the copper intrauterine device (ParaGard®) when placed immediately after childbirth. Many women in the United States have unintended pregnancies. Long-acting reversible birth control methods, like the copper intrauterine device (IUD), help prevent unintended pregnancy. This is because, once in place, the copper IUD provides excellent pregnancy prevention, and women using it do not have to do anything extra to make sure it works (like taking a birth control pill every day, for example). The copper IUD is safe and well liked among women who use it. Around the world, women have been getting their IUD fitted right after childbirth for the past 20 years, and this practice has been shown to be safe. This service has been offered at HUP since early 2014. When the IUD is placed after birth, there is a chance that it could fall out, as the uterus shrinks back to its pre-pregnancy size. Women who get their IUD fitted right after childbirth will be observed, and describe the rate of IUD expulsion at 6 months postpartum. Factors associated with IUD expulsion will be noted. Adult pregnant women delivering at the Hospital of the University of Pennsylvania, desiring an immediate IUD, and willing to follow up 6 months after birth, will be eligible to participate.

Conditions

• Postpartum
• Intrauterine Devices, Copper

Interventions

Type	Name	Description
OTHER	No intervention - observational study only

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2016-03-11
• Last updated: 2018-11-15

Locations

1 site across 1 country: United States