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

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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum; Intrauterine Devices, Copper
• Intervention / Treatment: Other: No intervention - observational study only

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.

• Study Type: Observational
• Enrollment (Actual): 309

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19143
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult pregnant women, at least 24 weeks' gestation, anticipating a delivery and desiring an immediate postplacental TCu380A IUD, and adult women who have had a delivery and received an immediate post placental TCu380A IUD.

Description

Inclusion Criteria:

• Adult woman age 18 years or more
• Pregnant, 24 weeks 0 days gestation or more OR who have had a delivery at 34 weeks 0 days gestation or more
• Anticipating a delivery at the Hospital of the University of Pennsylvania
• Desiring an immediate postplacental TCu380A IUD, OR who have given birth and received an immediate postplacental TCu380A IUD
• Able and willing to give consent in English
• Willing to follow up 6 months after delivery

Exclusion Criteria:

• Allergy or contraindication to TCu380A
• Known cervical cancer or carcinoma in situ
• History of undiagnosed abnormal vaginal bleeding prior to pregnancy
• Unwilling to follow up in the six months following delivery will be excluded

Additional exclusion criteria apply after delivery:

• Preterm delivery (33 weeks 6 days gestation or less at birth)
• Clinical diagnosis of chorioamnionitis or treatment for presumed chorioamnionitis
• No longer desiring immediate postplacental TCu380A placement
• Subjects aged less than 18 years
• Men are excluded by the nature of this women's health research.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaginal delivery; Women who have had a copper IUD placed within 10 minutes of a vaginal delivery of at least 34 weeks 0 days gestation.	Other: No intervention - observational study only
Cesarean delivery; Women who have had a copper IUD placed within 10 minutes of a cesarean delivery of at least 34 weeks 0 days gestation.	Other: No intervention - observational study only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective is to measure the rate of expulsion of the copper intrauterine device (TCu380A, marketed as ParaGard®) when placed within 10 minutes of placental delivery among women delivering at the University of Pennsylvania.	6 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: March 7, 2016
• First Posted (Estimate): March 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 822078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO