ContraceptionNCT03305081
Patient Compliance With Long-Acting Reversible Contraception Administration
A study testing Levonorgestrel IUD, copper IUD, etonorgestrel implant in people with Contraception, run by Tulane University School of Medicine at 1 site in United States.
Trial summary
This a randomized control trial to identify if patients who desire LARC are more likely to have success receiving the desired form of contraception if it is placed a) during the postpartum hospital stay, either in the immediate or early postpartum period, versus b) during the interval postpartum period as previously… Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Levonorgestrel IUD, copper IUD, etonorgestrel implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2014to 31 May 2016
- 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 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant, desires LARC postpartum
Who cannot join
- Medical contraindication to desired LARC, vaginal delivery complicated by fourth degree perineal laceration, history of pelvic inflammatory disease, uterine infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane Department of Obstetrics and Gynecology
New Orleans, Louisiana, 70018
About this study
Official title: Patient Compliance With Long-Acting Reversible Contraception Administration Immediately and Early Postpartum Versus Interval Postpartum
This a randomized control trial to identify if patients who desire LARC are more likely to have success receiving the desired form of contraception if it is placed a) during the postpartum hospital stay, either in the immediate or early postpartum period, versus b) during the interval postpartum period as previously done.
Read the detailed description
Randomized control trial with control group receiving LARC at 6 weeks postpartum and the study group receiving LARC in the immediate or early postpartum period. Outcomes will be measured by those who receive or do not receive LARC either in the hospital after delivery versus 6 weeks postpartum in accordance with the study subjects' randomized designation. Secondary outcomes of bleeding profile and satisfaction will also be assessed.
- Conditions
- Contraception
- Being tested
- Levonorgestrel IUD, copper IUD, etonorgestrel implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levonorgestrel IUD, copper IUD, etonorgestrel implantDevice
Long-acting reversible contraception
| Study group | Role | What they receive |
|---|---|---|
| Immediate or early placement | Experimental | Immediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum Receives: Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant |
| Interval placement | Active comparator | Interval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant Receives: Device: Levonorgestrel IUD, copper IUD, etonorgestrel implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Women With Placement of LARC
The outcome will be measured by the number of participants with LARC placement. The total number of women who expressed a desire to have postpartum contraception placed and randomized to the appropriate arm will be assessed.
Measured: 6 months
Secondary outcomes (1)
Patient Satisfaction With Method of LARC Using LARC Survey
Number of patients satisfied with LARC obtained by LARC survey at 6-weeks, 12-weeks postpartum, and 6 months postpartum. Patients identify Yes/No response via telephone survey asking, "Are you satisfied with this form of contraception?". Satisfaction determined if subject answers "Yes". A single value was calculated at the end of the study by summation at all three time points.
Measured: 6 Weeks, 12 weeks postpartum, 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 posted9 Oct 2017
- Study start22 Oct 2014
- Primary completion21 Dec 2015
- Study completion31 May 2016
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 (9)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Junya, MD, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305081
- Sponsor's protocol ID
- IRBNet ID 628424-1
- Status last verified
- Jan 2021
- First submitted
- 24 Nov 2014
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009 Dec;80(6):519-26. doi: 10.1016/j.contraception.2009.05.124. Epub 2009 Jul 10.
PubMed 19913145Celen S, Sucak A, Yildiz Y, Danisman N. Immediate postplacental insertion of an intrauterine contraceptive device during cesarean section. Contraception. 2011 Sep;84(3):240-3. doi: 10.1016/j.contraception.2011.01.006. Epub 2011 Feb 21.
PubMed 21843687Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.
PubMed 20966692Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011 Sep;84(3):244-8. doi: 10.1016/j.contraception.2011.01.007. Epub 2011 Feb 24.
PubMed 21843688Grimes DA, Lopez LM, Schulz KF, Van Vliet HA, Stanwood NL. Immediate post-partum insertion of intrauterine devices. Cochrane Database Syst Rev. 2010 May 12;(5):CD003036. doi: 10.1002/14651858.CD003036.pub2.
PubMed 20464722Guazzelli CA, de Queiroz FT, Barbieri M, Torloni MR, de Araujo FF. Etonogestrel implant in postpartum adolescents: bleeding pattern, efficacy and discontinuation rate. Contraception. 2010 Sep;82(3):256-9. doi: 10.1016/j.contraception.2010.02.010. Epub 2010 Mar 29.
PubMed 20705154Levi E, Cantillo E, Ades V, Banks E, Murthy A. Immediate postplacental IUD insertion at cesarean delivery: a prospective cohort study. Contraception. 2012 Aug;86(2):102-5. doi: 10.1016/j.contraception.2011.11.019. Epub 2012 Jan 20.
PubMed 22264666Shukla M, Qureshi S; Chandrawati. Post-placental intrauterine device insertion--a five year experience at a tertiary care centre in north India. Indian J Med Res. 2012 Sep;136(3):432-5.
PubMed 23041736Stuart GS, Bryant AG, O'Neill E, Doherty IA. Feasibility of postpartum placement of the levonorgestrel intrauterine system more than 6 h after vaginal birth. Contraception. 2012 Apr;85(4):359-62. doi: 10.1016/j.contraception.2011.08.005. Epub 2011 Sep 28.
PubMed 22067759
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Compliance With Long-Acting Reversible Contraception Administration Immediately and Early Postpartum Versus Interval Postpartum
- ClinicalTrials.gov ID
- NCT03305081
- Acronym / sponsor ID
- IRBNet ID 628424-1
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tulane University School of MedicineUniversity, hospital or other
- Study start
- 22 Oct 2014 (actual)
- Primary completion
- 21 Dec 2015 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This a randomized control trial to identify if patients who desire LARC are more likely to have success receiving the desired form of contraception if it is placed a) during the postpartum hospital stay, either in the immediate or early postpartum period, versus b) during the interval postpartum period as previously done.
Detailed description
Randomized control trial with control group receiving LARC at 6 weeks postpartum and the study group receiving LARC in the immediate or early postpartum period. Outcomes will be measured by those who receive or do not receive LARC either in the hospital after delivery versus 6 weeks postpartum in accordance with the study subjects' randomized designation. Secondary outcomes of bleeding profile and satisfaction will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate or early placement | Experimental | Device: Levonorgestrel IUD, copper IUD, etonorgestrel implantImmediate or early placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant (within 48 hours) postpartum |
| Interval placement | Active comparator | Device: Levonorgestrel IUD, copper IUD, etonorgestrel implantInterval (4-6 weeks) postpartum placement of levonorgestrel IUD, copper IUD, or etonorgestrel sub dermal implant |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant, desires LARC postpartum
Key exclusion criteria (1 listed)
- Medical contraindication to desired LARC, vaginal delivery complicated by fourth degree perineal laceration, history of pelvic inflammatory disease, uterine infection
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 |
|---|---|---|
| Levonorgestrel IUD, copper IUD, etonorgestrel implantLong-acting reversible contraception | Device | Immediate or early placement, Interval placement |
Primary outcome
Number of Women With Placement of LARC
Time frame: 6 months
The outcome will be measured by the number of participants with LARC placement. The total number of women who expressed a desire to have postpartum contraception placed and randomized to the appropriate arm will be assessed.
1 secondary outcome
Patient Satisfaction With Method of LARC Using LARC Survey
Time frame: 6 Weeks, 12 weeks postpartum, 6 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19913145Brito MB, Ferriani RA, Quintana SM, Yazlle ME, Silva de Sa MF, Vieira CS. Safety of the etonogestrel-releasing implant during the immediate postpartum period: a pilot study. Contraception. 2009 Dec;80(6):519-26. doi: 10.1016/j.contraception.2009.05.124. Epub 2009 Jul 10.
- Results publication: PubMed 21843687Celen S, Sucak A, Yildiz Y, Danisman N. Immediate postplacental insertion of an intrauterine contraceptive device during cesarean section. Contraception. 2011 Sep;84(3):240-3. doi: 10.1016/j.contraception.2011.01.006. Epub 2011 Feb 21.
- Results publication: PubMed 20966692Chen BA, Reeves MF, Hayes JL, Hohmann HL, Perriera LK, Creinin MD. Postplacental or delayed insertion of the levonorgestrel intrauterine device after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2010 Nov;116(5):1079-87. doi: 10.1097/AOG.0b013e3181f73fac.
- Results publication: PubMed 21843688Dahlke JD, Terpstra ER, Ramseyer AM, Busch JM, Rieg T, Magann EF. Postpartum insertion of levonorgestrel--intrauterine system at three time periods: a prospective randomized pilot study. Contraception. 2011 Sep;84(3):244-8. doi: 10.1016/j.contraception.2011.01.007. Epub 2011 Feb 24.
- Results publication: PubMed 20464722Grimes DA, Lopez LM, Schulz KF, Van Vliet HA, Stanwood NL. Immediate post-partum insertion of intrauterine devices. Cochrane Database Syst Rev. 2010 May 12;(5):CD003036. doi: 10.1002/14651858.CD003036.pub2.
- Results publication: PubMed 20705154Guazzelli CA, de Queiroz FT, Barbieri M, Torloni MR, de Araujo FF. Etonogestrel implant in postpartum adolescents: bleeding pattern, efficacy and discontinuation rate. Contraception. 2010 Sep;82(3):256-9. doi: 10.1016/j.contraception.2010.02.010. Epub 2010 Mar 29.
- Results publication: PubMed 22264666Levi E, Cantillo E, Ades V, Banks E, Murthy A. Immediate postplacental IUD insertion at cesarean delivery: a prospective cohort study. Contraception. 2012 Aug;86(2):102-5. doi: 10.1016/j.contraception.2011.11.019. Epub 2012 Jan 20.
- Results publication: PubMed 23041736Shukla M, Qureshi S; Chandrawati. Post-placental intrauterine device insertion--a five year experience at a tertiary care centre in north India. Indian J Med Res. 2012 Sep;136(3):432-5.
- Results publication: PubMed 22067759Stuart GS, Bryant AG, O'Neill E, Doherty IA. Feasibility of postpartum placement of the levonorgestrel intrauterine system more than 6 h after vaginal birth. Contraception. 2012 Apr;85(4):359-62. doi: 10.1016/j.contraception.2011.08.005. Epub 2011 Sep 28.
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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.
Sara Junya, MD principal investigator
Tulane University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levonorgestrel IUD, copper IUD, etonorgestrel implant in people with Contraception, run by Tulane University School of Medicine 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Jan 2021. 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 22 Jan 2021). 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 Women With Placement of LARC (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 NCT03305081, which also lists 9 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 Jan 2021.