NCT00540046

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
5 years until next milestone

Results Posted

Study results publicly available

January 13, 2015

Completed
Last Updated

February 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.8 years

First QC Date

October 4, 2007

Results QC Date

January 1, 2015

Last Update Submit

January 23, 2015

Conditions

Contraception Behavior

Keywords

IUDSecond trimester terminationContraception

Outcome Measures

Primary Outcomes (1)

  • Use of IUD

    Number of participants using Copper T380A IUD 6 months after surgery

    6 months

Secondary Outcomes (1)

  • Expulsion

    6 months

Study Arms (2)

A/Immediate

ACTIVE COMPARATOR

The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure

Device: Copper T 380A IUD

B/Delayed

ACTIVE COMPARATOR

The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.

Device: Copper T 380A IUD

Interventions

Copper T 380A IUDDEVICE

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

A/ImmediateB/Delayed

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bellevue Hospital

New York, New York, 10016, United States

Location

Parkmed Women's Clinic

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Limitations and Caveats

IUD presence not always confirmed by a provider at 6-month visit but self-reported. Study not powered to detect a difference in expulsion rates due to prohibitively high sample size. Very high-risk population.

Results Point of Contact

Title
Miriam Cremer MD MPH
Organization
Basic Health International
miriam.cremer@gmail.com
(646) 593-8694

Study Officials

  • Miriam L. Cremer, MD, MPH

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

October 4, 2007

First Posted

October 5, 2007

Study Start

April 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 9, 2015

Results First Posted

January 13, 2015

Record last verified: 2015-01

Locations

US(2)