ContraceptionNCT01443533
Study of Birth Control Use After Childbirth
A study testing LARC Script in people with Contraception, run by WakeMed Health and Hospitals at 1 site in United States.
Trial summary
This study is a randomized controlled trial that will evaluate the impact of a brief educational script on the method of birth control that women receive at their 6-week postpartum visit. The one-minute script ("LARC script") is given to women in the hospital during their postpartum admission. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- LARC Script
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to May 2012
- Phase
- Interventional
- 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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Women who are admitted to the postpartum unit at WakeMed Hospital
- Delivery of a live infant >24 weeks gestational age
- Age 14-45 years
- Ability to speak either English or Spanish fluently
- Willing to be contacted by phone until at least 8 weeks after delivery
Who cannot join
- History of a tubal ligation or hysterectomy
- Partner has already had a vasectomy
- History of fertility treatment to conceive this pregnancy
- Previous randomization into the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Brief Educational Script on Postpartum Contraceptive Uptake
This study is a randomized controlled trial that will evaluate the impact of a brief educational script on the method of birth control that women receive at their 6-week postpartum visit. The one-minute script ("LARC script") is given to women in the hospital during their postpartum admission. It informs patients about long-acting reversible contraceptive (LARC) methods, specifically the contraceptive implant and the intrauterine device. The investigators hypothesize that women who are randomized to receive the LARC script will be more likely to report that they are using a LARC method, when queried immediately after their six-week postpartum visit.
- Conditions
- Contraception
- Being tested
- LARC Script
- Keywords
- Contraception, Contraception behavior, Postnatal care, Health education, Randomized controlled trial
- Medical subject headings
- Contraception Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARC ScriptBehavioural
The LARC Script is a one-minute educational script that describes long-acting reversible contraceptive methods.
| Study group | Role | What they receive |
|---|---|---|
| LARC script | Experimental | Received routine postpartum counseling and LARC script. Receives: Behavioral: LARC Script |
| No LARC script | No intervention | Received only routine postpartum counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported use of LARC method
Measured: After six-week postpartum visit
Secondary outcomes (3)
Self-reported interest in use of a LARC method
Measured: After six-week postpartum visit
Self-reported use of any contraceptive method
Measured: After six-week postpartum visit
Self-reported reasons for not using the contraceptive method of choice
Measured: After six-week postpartum visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- WakeMed Health and Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Jennifer H. Tang, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443533
- Sponsor's protocol ID
- WakeMed 864
- Status last verified
- Jun 2012
- First submitted
- 27 Sep 2011
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11.
PubMed 20541171Lopez LM, Hiller JE, Grimes DA. Postpartum education for contraception: a systematic review. Obstet Gynecol Surv. 2010 May;65(5):325-31. doi: 10.1097/OGX.0b013e3181e57127.
PubMed 20591202Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. doi: 10.1097/01.AOG.0000245447.56585.a0.
PubMed 17138775Conde-Agudelo A, Rosas-Bermudez A, Kafury-Goeta AC. Birth spacing and risk of adverse perinatal outcomes: a meta-analysis. JAMA. 2006 Apr 19;295(15):1809-23. doi: 10.1001/jama.295.15.1809.
PubMed 16622143Zerden ML, Tang JH, Stuart GS, Norton DR, Verbiest SB, Brody S. Barriers to Receiving Long-acting Reversible Contraception in the Postpartum Period. Womens Health Issues. 2015 Nov-Dec;25(6):616-21. doi: 10.1016/j.whi.2015.06.004. Epub 2015 Jul 23.
PubMed 26212318
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Brief Educational Script on Postpartum Contraceptive Uptake
- ClinicalTrials.gov ID
- NCT01443533
- Acronym / sponsor ID
- WakeMed 864
- Conditions
- Contraception
- Keywords
- Contraception, Contraception behavior, Postnatal care, Health education, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- WakeMed Health and HospitalsUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Sep 2011 (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.
This study is a randomized controlled trial that will evaluate the impact of a brief educational script on the method of birth control that women receive at their 6-week postpartum visit. The one-minute script ("LARC script") is given to women in the hospital during their postpartum admission. It informs patients about long-acting reversible contraceptive (LARC) methods, specifically the contraceptive implant and the intrauterine device. The investigators hypothesize that women who are randomized to receive the LARC script will be more likely to report that they are using a LARC method, when queried immediately after their six-week postpartum visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LARC script | Experimental | Behavioral: LARC ScriptReceived routine postpartum counseling and LARC script. |
| No LARC script | No intervention | –Received only routine postpartum counseling |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Women who are admitted to the postpartum unit at WakeMed Hospital
- Delivery of a live infant >24 weeks gestational age
- Age 14-45 years
- Ability to speak either English or Spanish fluently
- Willing to be contacted by phone until at least 8 weeks after delivery
Key exclusion criteria (4 listed)
- History of a tubal ligation or hysterectomy
- Partner has already had a vasectomy
- History of fertility treatment to conceive this pregnancy
- Previous randomization into the study
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 |
|---|---|---|
| LARC ScriptThe LARC Script is a one-minute educational script that describes long-acting reversible contraceptive methods. | Behavioural | LARC script |
Primary outcome
Self-reported use of LARC method
Time frame: After six-week postpartum visit
3 secondary outcomes
Self-reported interest in use of a LARC method
Time frame: After six-week postpartum visit
Self-reported use of any contraceptive method
Time frame: After six-week postpartum visit
Self-reported reasons for not using the contraceptive method of choice
Time frame: After six-week postpartum visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Background: PubMed 20541171Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11.
- Background: PubMed 20591202Lopez LM, Hiller JE, Grimes DA. Postpartum education for contraception: a systematic review. Obstet Gynecol Surv. 2010 May;65(5):325-31. doi: 10.1097/OGX.0b013e3181e57127.
- Background: PubMed 17138775Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. doi: 10.1097/01.AOG.0000245447.56585.a0.
- Background: PubMed 16622143Conde-Agudelo A, Rosas-Bermudez A, Kafury-Goeta AC. Birth spacing and risk of adverse perinatal outcomes: a meta-analysis. JAMA. 2006 Apr 19;295(15):1809-23. doi: 10.1001/jama.295.15.1809.
- Derived from this study: PubMed 26212318Zerden ML, Tang JH, Stuart GS, Norton DR, Verbiest SB, Brody S. Barriers to Receiving Long-acting Reversible Contraception in the Postpartum Period. Womens Health Issues. 2015 Nov-Dec;25(6):616-21. doi: 10.1016/j.whi.2015.06.004. Epub 2015 Jul 23.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LARC Script in people with Contraception, run by WakeMed Health and Hospitals 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 5 inclusion and 4 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 28 Jun 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-reported use of LARC method (time frame: After six-week postpartum visit). 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 NCT01443533, which also lists 5 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 28 Jun 2012.