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

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ClinicalTrials.gov Identifier: NCT00540046
Recruitment Status : Completed
First Posted : October 5, 2007
Results First Posted : January 13, 2015
Last Update Posted : February 9, 2015
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Miriam Cremer, New York University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Contraception Behavior
Intervention: Device: Copper T 380A IUD

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
A/Immediate

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

Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure.

B/Delayed

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

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


Participant Flow:   Overall Study
    A/Immediate   B/Delayed
STARTED   104   111 
COMPLETED   71   88 
NOT COMPLETED   33   23 
Lost to Follow-up                33                23 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
215 subjects were enrolled and randomized to the A/Immediate or B/Delayed group.

Reporting Groups
  Description
A/Immediate

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

Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure.

B/Delayed

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

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

Total Total of all reporting groups

Baseline Measures
   A/Immediate   B/Delayed   Total 
Overall Participants Analyzed 
[Units: Participants]
 104   111   215 
Age 
[Units: Years]
Mean (Full Range)
 24 
 (16 to 41) 
 23.4 
 (16 to 43) 
 23.7 
 (16 to 43) 
Gender, Customized 
[Units: Participants]
     
Female   104   111   215 
Race/Ethnicity, Customized 
[Units: Participants]
     
Black   48   52   100 
Hispanic or Latino   43   39   82 
White   4   6   10 
Asian or South Asian   1   4   5 
Mixed   4   5   9 
Other   2   3   5 
Missing   2   2   4 
Gestational age 
[Units: Weeks]
Mean (Full Range)
 19.2 
 (12 to 24) 
 18.8 
 (12 to 24) 
 19.0 
 (12 to 24) 


  Outcome Measures

1.  Primary:   Use of IUD   [ Time Frame: 6 months ]

2.  Secondary:   Expulsion   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

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.



  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Miriam Cremer MD MPH
Organization: Basic Health International
phone: (646) 593-8694
e-mail: miriam.cremer@gmail.com



Responsible Party: Miriam Cremer, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00540046     History of Changes
Other Study ID Numbers: Post Abortion Copper T IUD
First Submitted: October 4, 2007
First Posted: October 5, 2007
Results First Submitted: January 1, 2015
Results First Posted: January 13, 2015
Last Update Posted: February 9, 2015