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

NCT02706340 | Completed

• 1 other identifier: 822078
• Study Type: observational
• Target: 309
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum; Intrauterine Devices, Copper

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Interventions

No intervention - observational study only OTHER

Cesarean delivery; Vaginal delivery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19143, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: March 11, 2016
• Study Start: April 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: November 15, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)