PregnancyNCT02428530
Partner Involvement During Pregnancy and Its Association With Maternal Health Behaviors
An observational study of Pregnancy and Smoking, run by Ohio State University.
Trial summary
This study assessed the relationship between pregnant women, partner support, and cigarette and alcohol use in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- What is being tested?
- Questionnaires
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jul 2013
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Paternal support is related to positive pregnancy outcomes. We explored the relationship between paternal involvement and maternal smoking and alcohol consumption during pregnancy. This was an IRB-approved cross sectional study. Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included.
Who may be able to join
- Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included.
Who cannot join
- Non-English speaking.
About this study
This study assessed the relationship between pregnant women, partner support, and cigarette and alcohol use in pregnancy.
Read the detailed description
Paternal support is related to positive pregnancy outcomes. We explored the relationship between paternal involvement and maternal smoking and alcohol consumption during pregnancy. This was an IRB-approved cross sectional study. Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included. Demographic and health information was collected. A composite support score for each woman was generated from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a scale from 5 - 35. Support scores were evaluated with women's current smoking and drinking status using ANOVA and Student's t-test.
- Being tested
- Questionnaires
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Norbeck Social Support Questionnaire (NSSQ)
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite support score for each woman from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a scale from 5 - 35.
Cigarette and Alcohol use in pregnancy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2015 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Thomas Jefferson University
- Responsible party
- Principal investigator, Brett Worly, MD, Ohio State University
- Investigators
- Brett Worly, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02428530
- Sponsor's protocol ID
- 11D.413
- Status last verified
- Apr 2015
- First submitted
- 23 Apr 2015
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partner Involvement During Pregnancy and Its Association With Maternal Health Behaviors
- ClinicalTrials.gov ID
- NCT02428530
- Acronym / sponsor ID
- 11D.413
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Thomas Jefferson University
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Apr 2015 (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 assessed the relationship between pregnant women, partner support, and cigarette and alcohol use in pregnancy.
Detailed description
Paternal support is related to positive pregnancy outcomes. We explored the relationship between paternal involvement and maternal smoking and alcohol consumption during pregnancy. This was an IRB-approved cross sectional study. Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included. Demographic and health information was collected. A composite support score for each woman was generated from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a scale from 5 - 35. Support scores were evaluated with women's current smoking and drinking status using ANOVA and Student's t-test.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Paternal support is related to positive pregnancy outcomes. We explored the relationship between paternal involvement and maternal smoking and alcohol consumption during pregnancy. This was an IRB-approved cross sectional study. Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included.
Key inclusion criteria (1 listed)
- Pregnant women between the ages of 18 - 44 years old and their partners were surveyed in the outpatient OB/GYN offices of Thomas Jefferson University. Women who identified their partner as their main support were included.
Key exclusion criteria (1 listed)
- Non-English speaking.
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 |
|---|---|---|
| QuestionnairesNorbeck Social Support Questionnaire (NSSQ) | Other | – |
Primary outcome
A composite support score for each woman from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a scale from 5 - 35.
Time frame: 2 months
Cigarette and Alcohol use in pregnancy
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 Apr 2015.
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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.
Brett Worly, MD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Smoking, run by Ohio State University.
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 28 Apr 2015. 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 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?
A composite support score for each woman from a modified version of the Norbeck Social Support Questionnaire (NSSQ) on a scale from 5 - 35. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2015.