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

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT00540046
• Collaborator: Icahn School of Medicine at Mount Sinai (Other)
• Enrollment: 215
• Locations: 2
• Arms: 2
• Duration (Months): 34.1
• Patients Per Site: 107.5
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception Behavior	Device: Copper T 380A IUD	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 215 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Device: Copper T 380A IUD; Copper T 380A IUD will be placed at the 2-4 week post-operative visit.
Active Comparator: 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.	Device: Copper T 380A IUD; Copper T 380A IUD will be placed at the 2-4 week post-operative visit.

Outcome Measures

Primary Outcome Measures

1. Use of IUD [6 months]

   Number of participants using Copper T380A IUD 6 months after surgery

Secondary Outcome Measures

1. Expulsion [6 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bellevue Hospital	New York	New York	United States	10016
2	Parkmed Women's Clinic	New York	New York	United States	10017

Sponsors and Collaborators

• NYU Langone Health
• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Miriam L. Cremer, MD, MPH, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Miriam Cremer, Clinical Assistant Professor, NYU Langone Health
• ClinicalTrials.gov Identifier: NCT00540046
• Other Study ID Numbers: Post Abortion Copper T IUD
• First Posted: Oct 5, 2007
• Last Update Posted: Feb 9, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by Miriam Cremer, Clinical Assistant Professor, NYU Langone Health: IUD; Second trimester termination; Contraception
• Additional relevant MeSH terms: Copper

Study Results

Participant Flow

Arm/Group Title	A/Immediate	B/Delayed
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

Baseline Characteristics

Arm/Group Title	A/Immediate	B/Delayed	Total
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 Participants	104	111	215
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	24	23.4	23.7
Sex/Gender, Customized (participants) [Number]
Female	104 100%	111 100%	215 100%
Race/Ethnicity, Customized (participants) [Number]
Black	48 46.2%	52 46.8%	100 46.5%
Hispanic or Latino	43 41.3%	39 35.1%	82 38.1%
White	4 3.8%	6 5.4%	10 4.7%
Asian or South Asian	1 1%	4 3.6%	5 2.3%
Mixed	4 3.8%	5 4.5%	9 4.2%
Other	2 1.9%	3 2.7%	5 2.3%
Missing	2 1.9%	2 1.8%	4 1.9%
Gestational age (weeks) [Mean (Full Range) ]
Mean (Full Range) [weeks]	19.2	18.8	19.0

Outcome Measures

1. Primary Outcome

Title	Use of IUD
Description	Number of participants using Copper T380A IUD 6 months after surgery
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	A/Immediate	B/Delayed
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.
Measure Participants	71	88
Number [participants]	58 55.8%	25 22.5%

2. Secondary Outcome

Title	Expulsion
Description	IUD was not removed by provider but fell out on its own.
Time Frame	6 months

Outcome Measure Data

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
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.
Measure Participants	64	26
Number [percentage of expulsions]	3.1	0

Adverse Events

Time Frame	6 months
Arm/Group Title	A/Immediate		B/Delayed
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	A/Immediate		B/Delayed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/111 (0%)
Other (Not Including Serious) Adverse Events
	A/Immediate		B/Delayed
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/104 (1.9%)		0/111 (0%)
Reproductive system and breast disorders
Expulsion	2/104 (1.9%)	2	0/111 (0%)	0

Limitations/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.

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.