Intrauterine Device PlacementNCT00986089
Intrauterine Device (IUD) Placement at the Time of Cesarean Section
An observational study of Intrauterine Device Placement, run by University of Kentucky.
Trial summary
To evaluate the continuation of the Copper IUD at one year after placement through the cesarean incision into the uterus at the time of cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Device Placement
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant women ages 18-40 who are undergoing a scheduled cesarean section, or women who are attempting to VBAC and want an IUD post partum will be eligible.
Who may be able to join
- Desire an IUD post-partum and are willing to use the copper IUD.
- They will also need to be patients at one of our OBGYN clinics at the university of Kentucky.
Who cannot join
- Post-partum hemorrhage,
- Chorioamnionitis (or a fever >101 at the time of cesarean),
- Women on antibiotic or immunosuppressive therapies,
- Cervical dilation > 5 cm at the time of c-section, OR
- Excessive intraoperative blood loss.
- Also women with contraindications to a copper IUD: Wilson's disease, unusual uterine shape or known uterine anomaly.
About this study
Official title: Pilot Study of Copper IUD Placement at the Time of Cesarean Section
To evaluate the continuation of the Copper IUD at one year after placement through the cesarean incision into the uterus at the time of cesarean section.
- Conditions
- Intrauterine Device Placement
- Keywords
- post-placental, IUD, Copper IUD, cesarean section, immediate post-partum, continuation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| women who have an IUD placed at the time of c-section | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation at one year
Measured: 1 year
Secondary outcomes (2)
satisfaction with placement at time of cesarean
Measured: 4-6 months and 1 year
bleeding profile
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startAug 2008
- Primary completionJul 2010
- Study completionJul 2010
Why it stopped: Principal Investigator left the University of Kentucky before enrollment could begin.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intrauterine Device PlacementStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- Duramed Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986089
- Sponsor's protocol ID
- 08-0938-F6A
- Status last verified
- Aug 2013
- First submitted
- 25 Sep 2009
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hayes JL, Cwiak C, Goedken P, Zieman M. A pilot clinical trial of ultrasound-guided postplacental insertion of a levonorgestrel intrauterine device. Contraception. 2007 Oct;76(4):292-6. doi: 10.1016/j.contraception.2007.06.003. Epub 2007 Aug 6.
PubMed 17900440Liu BH, Zhang LY, Zhang BR. Intrauterine contraceptive device insertion with suture fixation at cesarean section. Chin Med J (Engl). 1983 Feb;96(2):141-4.
PubMed 6406171Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up. Contraception. 2006 Nov;74(5):376-81. doi: 10.1016/j.contraception.2006.07.003. Epub 2006 Sep 15.
PubMed 17046378
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Copper IUD Placement at the Time of Cesarean Section
- ClinicalTrials.gov ID
- NCT00986089
- Acronym / sponsor ID
- 08-0938-F6A
- Conditions
- Intrauterine Device Placement
- Keywords
- post-placental, IUD, Copper IUD, cesarean section, immediate post-partum, continuation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left the University of Kentucky before enrollment could begin.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- Duramed Research
- Study start
- Aug 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 29 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the continuation of the Copper IUD at one year after placement through the cesarean incision into the uterus at the time of cesarean section.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women who have an IUD placed at the time of c-section | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women ages 18-40 who are undergoing a scheduled cesarean section, or women who are attempting to VBAC and want an IUD post partum will be eligible.
Key inclusion criteria (2 listed)
- Desire an IUD post-partum and are willing to use the copper IUD.
- They will also need to be patients at one of our OBGYN clinics at the university of Kentucky.
Key exclusion criteria (6 listed)
- Post-partum hemorrhage,
- Chorioamnionitis (or a fever >101 at the time of cesarean),
- Women on antibiotic or immunosuppressive therapies,
- Cervical dilation > 5 cm at the time of c-section, OR
- Excessive intraoperative blood loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Continuation at one year
Time frame: 1 year
2 secondary outcomes
satisfaction with placement at time of cesarean
Time frame: 4-6 months and 1 year
bleeding profile
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Background: PubMed 17900440Hayes JL, Cwiak C, Goedken P, Zieman M. A pilot clinical trial of ultrasound-guided postplacental insertion of a levonorgestrel intrauterine device. Contraception. 2007 Oct;76(4):292-6. doi: 10.1016/j.contraception.2007.06.003. Epub 2007 Aug 6.
- Background: PubMed 6406171Liu BH, Zhang LY, Zhang BR. Intrauterine contraceptive device insertion with suture fixation at cesarean section. Chin Med J (Engl). 1983 Feb;96(2):141-4.
- Background: PubMed 17046378Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up. Contraception. 2006 Nov;74(5):376-81. doi: 10.1016/j.contraception.2006.07.003. Epub 2006 Sep 15.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Device Placement, run by University of Kentucky.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Continuation at one year (time frame: 1 year). 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 NCT00986089, which also lists 3 linked publications.
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 22 Dec 2016.