Intrauterine Device ExpulsionPhase 4NCT01439802
Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery
A Phase 4 study testing Copper IUD placement at time Cesarean Delivery (Copper T 380A) in people with Intrauterine Device Expulsion, run by Albert Einstein College of Medicine at 2 sites in United States.
Trial summary
The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Device Expulsion
- What is being tested?
- Copper IUD placement at time Cesarean Delivery (Copper T 380A)
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to May 2010
- Phase
- Phase 4
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton gestation
- greater than 35 weeks gestation
- speaks English or Spanish
- desires IUD for contraception
- undergoing a cesarean delivery
Who cannot join
- evidence of chorioamnionitis
- history of chlamydia within this pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jacobi Medical Center
The Bronx, New York, 10461
Montefiore Medical Center, Weiler Division
The Bronx, New York, 10461
About this study
Official title: Transcesarean IUD Insertion: A Prospective Cohort Study
The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.
Read the detailed description
This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.
- Conditions
- Intrauterine Device Expulsion
- Being tested
- Copper IUD placement at time Cesarean Delivery (Copper T 380A)
- Keywords
- Postpartum IUD, Cesarean Delivery, 6 months postpartum, satisfaction
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copper IUD placement at time Cesarean Delivery (Copper T 380A)Device
Also called Copper T 380A
Placement of Paragard IUD at time of Cesarean Delivery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Expulsion of IUD
Number of participants with Expulsion of IUDs placed at time of cesarean delivery.
Measured: 6 week postpartum
Secondary outcomes (2)
Satisfaction of IUD Placement
Satisfaction of subjects who received an IUD at time of cesarean delivery was measured based on a telephone survey administered 6 months postpartum. A 4-point Likert scale ("Very Happy/Happy", "Somewhat Happy", "Unsure", "Unhappy") was used to evaluate participants' attitude toward the IUD.
Measured: 6 months postpartum
Number of Participants With Expulsion of IUD
Number of participants with Expulsion of IUDs placed at time of cesarean delivery.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startAug 2008
- Primary completionNov 2009
- Study completionMay 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 Intrauterine Device ExpulsionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amitasrigowri Murthy, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439802
- Sponsor's protocol ID
- 2007-345-002
- Status last verified
- Apr 2023
- First submitted
- 21 Sep 2011
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcesarean IUD Insertion: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01439802
- Acronym / sponsor ID
- 2007-345-002
- Conditions
- Intrauterine Device Expulsion
- Keywords
- Postpartum IUD, Cesarean Delivery, 6 months postpartum, satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 23 Sep 2011 (estimated)
- Results
- Posted 29 Dec 2022
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 determine the expulsion rates of copper Intrauterine Devices (IUDs) placed at time of Cesarean Delivery.
Detailed description
This was a prospective clinical study with 90 patients undergoing cesarean section. After delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy site. IUD placement was confirmed by visualization of the strings at the cervical os or via ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call was to ensure that each subject attended her postpartum visit, had an evaluation of IUD placement and then we performed a survey. This survey used a Likert Scale to measure each subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied, neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- singleton gestation
- greater than 35 weeks gestation
- speaks English or Spanish
- desires IUD for contraception
- undergoing a cesarean delivery
Key exclusion criteria (2 listed)
- evidence of chorioamnionitis
- history of chlamydia within this pregnancy
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 IUD placement at time Cesarean Delivery (Copper T 380A)Also: Copper T 380APlacement of Paragard IUD at time of Cesarean Delivery | Device | – |
Primary outcome
Number of Participants With Expulsion of IUD
Time frame: 6 week postpartum
Number of participants with Expulsion of IUDs placed at time of cesarean delivery.
2 secondary outcomes
Satisfaction of IUD Placement
Time frame: 6 months postpartum
Number of Participants With Expulsion of IUD
Time frame: 6 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Intrauterine Device Expulsion
Recruiting
Pilot Study of Suction as a Mechanism of IUD Expulsion With Concomitant Menstrual Cup Use
IUD; Complications, Mechanical, Menstrual Cup
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.
Amitasrigowri Murthy, MD principal investigator
NYU School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Copper IUD placement at time Cesarean Delivery (Copper T 380A) in people with Intrauterine Device Expulsion, run by Albert Einstein College of Medicine 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 5 inclusion and 2 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 7 Apr 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2022). 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?
Number of Participants With Expulsion of IUD (time frame: 6 week postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Apr 2023.