Intrauterine DevicesIUD@CSDNCT01539759
Immediate Postplacental Insertion of IUDs at Time of Cesarean Delivery: A Randomized Clinical Trial
A study testing Immediate Postplacental Placement of an IUD during cesarean delivery in people with Intrauterine Devices and Cesarean Section, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Intrauterine Devices, Cesarean Section
- What is being tested?
- Immediate Postplacental Placement of an IUD during cesarean delivery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Aug 2014
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women ages 18-45
- Pregnant and greater than or equal to 24 weeks of estimated gestational age
- Live Pregnancy
- States a plan to use an Intrauterine Device (IUD) postpartum for contraception
- Plan for cesarean delivery
- Intend to stay in the Chapel Hill area for at least 6 months after birth
- Fluent in English or Spanish
Who cannot join
- known uterine anomalies
- allergies to any component of the IUD of their choosing
- known or suspected carcinoma of the breast
- known acute liver disease or liver tumor (benign or malignant)
- known or suspected uterine or cervical neoplasia
- active pelvic inflammatory disease
Show all 9Show fewer
- genital bleeding of unknown etiology
- history of solid organ transplantation
- positive test for gonorrhea or chlamydia during this pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
Official title: Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial
This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.
- Conditions
- Intrauterine Devices, Cesarean Section
- Being tested
- Immediate Postplacental Placement of an IUD during cesarean delivery
- Keywords
- Postpartum Contraception, Intrauterine Devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Postplacental Placement of an IUD during cesarean deliveryDevice
Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
| Study group | Role | What they receive |
|---|---|---|
| Interval IUD Placement | No intervention | Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery |
| Immediate Postplacental IUD placement | Experimental | Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta Receives: Device: Immediate Postplacental Placement of an IUD during cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
IUD Use
The use of an IUD at 6 months postpartum is the primary outcome measure
Measured: 6 months postpartum
Secondary outcomes (2)
IUD Expulsion
Measured: 0-6 months postpartum
Women's Satisfaction With IUDs
Measured: 0-6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2014
- Study completionAug 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine DevicesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Erika Levi, MD, MPH, University of North Carolina, Chapel Hill
- Investigators
- Erika Levi, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539759
- Sponsor's protocol ID
- 11-2477
- Acronym
- IUD@CSD
- Status last verified
- Sep 2017
- First submitted
- 21 Feb 2012
- Last updated
- 13 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Levi EE, Stuart GS, Zerden ML, Garrett JM, Bryant AG. Intrauterine Device Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):5-11. doi: 10.1097/AOG.0000000000000882.
PubMed 26241250
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Postplacental Insertion of Intrauterine Devices at Time of Cesarean Delivery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01539759
- Acronym / sponsor ID
- IUD@CSD / 11-2477
- Conditions
- Intrauterine Devices, Cesarean Section
- Keywords
- Postpartum Contraception, Intrauterine Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Mar 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Feb 2012 (estimated)
- Results
- Posted 9 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial among women who deliver by cesarean at UNC Women's Hospital and desire an Intrauterine Device (IUD) for contraception postpartum. After consenting, women will be randomized to receive an IUD at time of cesarean delivery or at a postpartum visit 4-8 weeks later. After randomization, subjects will be given a choice of the Mirena® IUD or the Paragard® IUD. Data collection will occur at baseline, delivery, the 4-8 week postpartum visit, and 2 follow-up encounters at 3 and 6 months. We hypothesize that women who receive an IUD at the time of cesarean will be more likely to use an IUD 6 months later than women who plan on receiving an IUD 4-8 weeks after delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interval IUD Placement | No intervention | –Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery |
| Immediate Postplacental IUD placement | Experimental | Device: Immediate Postplacental Placement of an IUD during cesarean deliveryWomen randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women ages 18-45
- Pregnant and greater than or equal to 24 weeks of estimated gestational age
- Live Pregnancy
- States a plan to use an Intrauterine Device (IUD) postpartum for contraception
- Plan for cesarean delivery
Key exclusion criteria (9 listed)
- known uterine anomalies
- allergies to any component of the IUD of their choosing
- known or suspected carcinoma of the breast
- known acute liver disease or liver tumor (benign or malignant)
- known or suspected uterine or cervical neoplasia
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 |
|---|---|---|
| Immediate Postplacental Placement of an IUD during cesarean deliveryWomen randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta | Device | Immediate Postplacental IUD placement |
Primary outcome
IUD Use
Time frame: 6 months postpartum
The use of an IUD at 6 months postpartum is the primary outcome measure
2 secondary outcomes
IUD Expulsion
Time frame: 0-6 months postpartum
Women's Satisfaction With IUDs
Time frame: 0-6 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26241250Levi EE, Stuart GS, Zerden ML, Garrett JM, Bryant AG. Intrauterine Device Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):5-11. doi: 10.1097/AOG.0000000000000882.
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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.
Erika Levi, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Postplacental Placement of an IUD during cesarean delivery in people with Intrauterine Devices and Cesarean Section, run by University of North Carolina, Chapel Hill at 1 site 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 7 inclusion and 9 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 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 9 Jul 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?
IUD Use (time frame: 6 months postpartum). 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 NCT01539759, which also lists 1 linked publication.
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 13 Oct 2017.