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N/A N=215 Randomized Health Services Research

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

Contraception Behavior

Enrolled (actual)
215
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Use of IUD — 58; 25 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Copper T 380A IUD (Device)
Age
Pediatric, Adult, Older Adult · 16+ yrs
Sex
Female
Sponsor
NYU Langone Health
Primary completion
Feb 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Use of IUD
58; 25
SECONDARY
Expulsion
3.1; 0

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00540046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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