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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
Enrollment 215

Recruitment Details  
Pre-assignment Details  
Arm/Group Title A/Immediate B/Delayed
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 104 111
Completed 71 88
Not Completed 33 23
Reason Not Completed
Lost to Follow-up             33             23
Arm/Group Title A/Immediate B/Delayed Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 104 111 215
Hide Baseline Analysis Population Description
215 subjects were enrolled and randomized to the A/Immediate or B/Delayed group.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 104 participants 111 participants 215 participants
24
(16 to 41)
23.4
(16 to 43)
23.7
(16 to 43)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 104 participants 111 participants 215 participants
104 111 215
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 111 participants 215 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  
Mean (Full Range)
Unit of measure:  Weeks
Number Analyzed 104 participants 111 participants 215 participants
19.2
(12 to 24)
18.8
(12 to 24)
19.0
(12 to 24)
1.Primary Outcome
Title Use of IUD
Hide Description Number of participants using Copper T380A IUD 6 months after surgery
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A/Immediate B/Delayed
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 71 88
Measure Type: Number
Unit of Measure: participants
58 25
2.Secondary Outcome
Title Expulsion
Hide Description IUD was not removed by provider but fell out on its own.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis here includes the 64/71 A/Immediate arm and 26/88 B/Delayed arm who received an IUD. In the A/Immediate arm, 5 women changed their mind post-randomization and in 2 cases, the provider chose not to place it. In the B/Delayed arm, reasons included not returning for follow-up visit, changing mind, and provider not wanting to place IUD.
Arm/Group Title A/Immediate B/Delayed
Hide Arm/Group Description:

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

IUD status was known six months post-abortion and insertion.

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

IUD status was known six months post-abortion.

Overall Number of Participants Analyzed 64 26
Measure Type: Number
Unit of Measure: percentage of expulsions
3.1 0
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A/Immediate B/Delayed
Hide Arm/Group Description

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.

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.

All-Cause Mortality
A/Immediate B/Delayed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A/Immediate B/Delayed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/104 (0.00%)      0/111 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A/Immediate B/Delayed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/104 (1.92%)      0/111 (0.00%)    
Reproductive system and breast disorders     
Expulsion *  2/104 (1.92%)  2 0/111 (0.00%)  0
*
Indicates events were collected by non-systematic assessment

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.

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
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