Contraception BehaviorNCT00540046

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

A study testing Copper T 380A IUD in people with Contraception Behavior, run by NYU Langone Health at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 16 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Contraception Behavior
What is being tested?: Copper T 380A IUD
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 215 participants
Where: 2 sitesUnited States
Study dates: Apr 2007to Feb 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 years and older
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Bellevue Hospital
New York, New York, 10016
Parkmed Women's Clinic
New York, New York, 10017

Other trials in United States

About this study

Official title: Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation

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.

Read the 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.

Conditions: Contraception Behavior
Being tested: Copper T 380A IUD
Keywords: IUD, Second trimester termination, Contraception
Medical subject headings: Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00540046
Study group	Role	What they receive
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 Receives: 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. Receives: Device: Copper T 380A IUD

What is being measured

The primary outcome is the main question the study is designed to answer.

Use of IUD
Number of participants using Copper T380A IUD 6 months after surgery
Measured: 6 months

Secondary outcomes (1)

Expulsion
IUD was not removed by provider but fell out on its own.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Feb 2010

First posted5 Oct 2007 (estimated)
Study startApr 2007
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Contraception BehaviorStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00540046
Sponsor's protocol ID: Post Abortion Copper T IUD
Status last verified: Jan 2015
First submitted: 4 Oct 2007
Last updated: 9 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
"Vasectomy: Right for Me?" Decision Support Tool
Vasectomy, Contraception

All Contraception Behavior trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immediate vs. Delayed Post-abortal Copper T 380A IUD Insertion in Cases Over 12 Weeks of Gestation
ClinicalTrials.gov ID: NCT00540046
Acronym / sponsor ID: Post Abortion Copper T IUD
Conditions: Contraception Behavior
Keywords: IUD, Second trimester termination, Contraception
Study type: Interventional
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: Icahn School of Medicine at Mount Sinai
Study start: Apr 2007
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 5 Oct 2007 (estimated)
Results: Posted 13 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A/Immediate	Active comparator	Device: Copper T 380A IUDThe patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure
B/Delayed	Active comparator	Device: Copper T 380A IUDThe delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.

Who may qualify

Ages: 16 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Copper T 380A IUDCopper T 380A IUD will be placed at the 2-4 week post-operative visit.	Device	A/Immediate, B/Delayed

Primary outcome

Use of IUD
Time frame: 6 months
Number of participants using Copper T380A IUD 6 months after surgery

1 secondary outcome

Expulsion
Time frame: 6 months

Results and safety

Results posted to the registry on 13 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A/Immediate	104	71
B/Delayed	111	88

Primary outcome: Use of IUD

Time frame: 6 months. Number. Unit: participants

Measure	A/Immediate n = 71	B/Delayed n = 88
Value	58	25

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A/Immediate	0 of 104 (0%)	2 of 104 (1.9%)	Not reported
B/Delayed	0 of 111 (0%)	0 of 111 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Contraception Behavior

Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
"Vasectomy: Right for Me?" Decision Support Tool
Vasectomy, Contraception

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Miriam L. Cremer, MD, MPH principal investigator

Icahn School of Medicine at Mount Sinai

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Copper T 380A IUD in people with Contraception Behavior, run by NYU Langone Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Use of IUD (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00540046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.