Preconception CareNCT02049554
Preconception Women's Health in Pediatric Practice Intervention
A study testing Preconception Care Screener in people with Preconception Care and Women's Health, run by Johns Hopkins University at 1 site in United States.
Trial summary
The aims of the intervention are: 1. Assess the feasibility and effectiveness of preconception health care initiated by pediatric clinicians on outcomes including women's access to primary care and contraceptive services; contraception and rapid repeat pregnancy rate and interpregnancy interval; and women's… Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preconception Care, Women's Health
- What is being tested?
- Preconception Care Screener
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 415 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Apr 2017
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Mothers with children ages 0 to 12 months presenting with their child for care at a participating pediatric office.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Harriet Lane Clinic
Baltimore, Maryland, 21287
About this study
The aims of the intervention are:
- Assess the feasibility and effectiveness of preconception health care initiated by pediatric clinicians on outcomes including women's access to primary care and contraceptive services; contraception and rapid repeat pregnancy rate and interpregnancy interval; and women's immunization rate, control of chronic illnesses, nutritional status, smoking and substance use, mental health and violence exposure; child and family health.
- Assess the cost-effectiveness of preconception health care initiated in pediatric practices.
The investigators will evaluate these outcomes with a clinic based trial comparing usual care to preconception care intervention.
- Conditions
- Preconception Care, Women's Health
- Being tested
- Preconception Care Screener
- Keywords
- preconception care, women's health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preconception Care ScreenerOther
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described |
| Preconception Care Screener Group | Experimental | Women's Health Screener and Clinician discussion Receives: Other: Preconception Care Screener |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of preconception care
Measured: 6 months
Receipt of Preconception Care
Measured: 12 months
Secondary outcomes (4)
Use of Highly Effective Contraception
Measured: 6 months
Use of Highly Effective Contraception
Measured: 12 months
Attendance at Preventive Health Care Visit
Measured: 6 months
Attendance at Preventive Health Care Visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionMar 2015
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preconception CareStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Zanvyl and Isabelle Krieger Fund, Abell Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049554
- Sponsor's protocol ID
- NA_00084255
- Status last verified
- Aug 2017
- First submitted
- 24 Jan 2014
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chilukuri N, Cheng TL, Psoter KJ, Mistry KB, Connor KA, Levy DJ, Upadhya KK. Effectiveness of a Pediatric Primary Care Intervention to Increase Maternal Folate Use: Results from a Cluster Randomized Controlled Trial. J Pediatr. 2018 Jan;192:247-252.e1. doi: 10.1016/j.jpeds.2017.09.020.
PubMed 29246348
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preconception Women's Health in Pediatric Practice Intervention
- ClinicalTrials.gov ID
- NCT02049554
- Acronym / sponsor ID
- NA_00084255
- Conditions
- Preconception Care, Women's Health
- Keywords
- preconception care, women's health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Zanvyl and Isabelle Krieger Fund, Abell Foundation
- Study start
- Oct 2013 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 30 Jan 2014 (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.
The aims of the intervention are:
- Assess the feasibility and effectiveness of preconception health care initiated by pediatric clinicians on outcomes including women's access to primary care and contraceptive services; contraception and rapid repeat pregnancy rate and interpregnancy interval; and women's immunization rate, control of chronic illnesses, nutritional status, smoking and substance use, mental health and violence exposure; child and family health.
- Assess the cost-effectiveness of preconception health care initiated in pediatric practices.
The investigators will evaluate these outcomes with a clinic based trial comparing usual care to preconception care intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | – |
| Preconception Care Screener Group | Experimental | Other: Preconception Care ScreenerWomen's Health Screener and Clinician discussion |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Mothers with children ages 0 to 12 months presenting with their child for care at a participating pediatric office.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Preconception Care Screener | Other | Preconception Care Screener Group |
Primary outcome
Receipt of preconception care
Time frame: 6 months
Receipt of Preconception Care
Time frame: 12 months
4 secondary outcomes
Use of Highly Effective Contraception
Time frame: 6 months
Use of Highly Effective Contraception
Time frame: 12 months
Attendance at Preventive Health Care Visit
Time frame: 6 months
Attendance at Preventive Health Care Visit
Time frame: 12 months
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 22 Aug 2017.
- Derived from this study: PubMed 29246348Chilukuri N, Cheng TL, Psoter KJ, Mistry KB, Connor KA, Levy DJ, Upadhya KK. Effectiveness of a Pediatric Primary Care Intervention to Increase Maternal Folate Use: Results from a Cluster Randomized Controlled Trial. J Pediatr. 2018 Jan;192:247-252.e1. doi: 10.1016/j.jpeds.2017.09.020.
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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 Preconception Care Screener in people with Preconception Care and Women's Health, run by Johns Hopkins University 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: finished, as of the sponsor's last update on 22 Aug 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?
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?
Receipt of preconception care (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT02049554, 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 22 Aug 2017.