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Completed

NCT Number: NCT00540046

Immediate vs. Delayed Insertion of Copper T 380A IUD After Termination of Pregnancy Over 12-weeks Gestation

The purpose of this study is to compare delayed vs. immediate insertion of the Copper T 380 IUD after termination of pregnancy after 12 weeks.

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Key information

Conditions

Contraception Behavior Behavior Reproductive Behavior

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bellevue Hospital, New York, United States

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About this study

Patients presenting to ParkMed Women's Clinic and the Reproductive Choice clinic at Bellevue Hospital for second trimester termination will be offered participation in this study. They will be randomized to either delayed or immediate Copper T 380A IUD insertion. The subjects will be seen at a 6 month follow-up visit and Copper T 380A IUD placement will be verified by physical exam. At this 6 month follow-up visit, subjects will fill out a satisfaction questionnaire.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women 16 years of age and older
  • intrauterine pregnancy > 14 weeks gestation
  • desires termination of pregnancy
  • desires IUD for contraception
  • ability to give informed consent
  • no contraindication for D+E

Exclusion criteria

  • unable to give informed consent
  • less than 16 years of age
  • congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
  • acute pelvic inflammatory disease (PID)
  • known or suspected uterine or cervical neoplasia or unresolved abnormal PAP smear
  • untreated acute cervicitis or vaginitis, until infection treated/controlled
  • confirmed Chlamydia trachomatis or Neisseria gonorrhea infection in the previous 90 days
  • acute liver disease or liver tumor (benign or malignant)
  • woman or partner currently with multiple sexual partners
  • history of Wilson's disease
  • hypersensitivity to any component of Copper T IUD

Treatment and study plan

Copper T 380A IUD

Device

Copper T 380A IUD will be placed at the 2-4 week post-operative visit.

Primary outcomes

  1. Use of IUD

    Time frame: 6 months

    Number of participants using Copper T380A IUD 6 months after surgery

Secondary outcomes

  1. Expulsion

    Time frame: 6 months

    IUD was not removed by provider but fell out on its own.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 5, 2007
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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