NCT02428530

Brief Summary

This study assessed the relationship between pregnant women, partner support, and cigarette and alcohol use in pregnancy.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

1 month

First QC Date

April 23, 2015

Last Update Submit

April 27, 2015

Conditions

PregnancySmoking

Outcome Measures

Primary Outcomes (1)

  • 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

    2 months

Interventions

QuestionnairesOTHER

Norbeck Social Support Questionnaire (NSSQ)

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Non-English speaking.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Brett Worly, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

June 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 28, 2015

Record last verified: 2015-04