Pregnancy PretermNCT02707237
Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling
A study testing Verbal counseling and Verbal, pictorial, written counseling in people with Pregnancy Preterm and Counseling, run by Cook County Health at 1 site in United States.
Trial summary
Providing verbal counseling supplemented with both written and pictorial information then verbal counseling alone is a more effective method of counseling parents with threatened preterm delivery Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy Preterm, Counseling
- What is being tested?
- Verbal counseling and Verbal, pictorial, written counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to 22 Oct 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women between 23 to 34 weeks gestation assessed by obstetrician to need counseling
Who cannot join
- Pregnancies with known life threatening defects considered as non compatible with life.
- Mothers previously admitted and counseled will also be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
About this study
Providing verbal counseling supplemented with both written and pictorial information then verbal counseling alone is a more effective method of counseling parents with threatened preterm delivery
Read the detailed description
Progress in the frontiers of neonatology has continually pushed back the limit of viability and significantly improved the survival of extremely preterm infants. An important component of medical management before a preterm delivery is counseling the parents about probabilities of survival and long term complications.
Hypothesis: Preterm counseling is more effective when parents receive verbal counseling supplemented with written and pictorial information then verbal counseling alone.
Methodology: There will be two groups of study (verbal, pictorial and written vs verbal alone). All patients admitted to the L and D department of Stroger hospital between 23 to 34 weeks of gestation with threatened premature delivery will be enrolled in the study. They will be randomly assigned to 1 of 2 groups. After counseling, parents will be asked to complete a 32 point questionnaire to check their knowledge of outcomes of prematurity.
To reach statistically significant results, the investigators will need 40 patients in each group. The study will be done over a period of one year
- Conditions
- Pregnancy Preterm, Counseling
- Being tested
- Verbal counseling, Verbal, pictorial, written counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal counselingOther
Verbal counseling done by physician
Verbal, pictorial, written counselingOther
verbal counseling in addition to gestational age specific written information and pictures will be given to parents
| Study group | Role | What they receive |
|---|---|---|
| Verbal counseling | Other | Parents with threatened delivery will receive verbal counseling only Receives: Other: Verbal counseling |
| Verbal, pictorial, written counseling | Other | Parents with threatened delivery will receive verbal counseling supplemented with pictorial and written information Receives: Other: Verbal, pictorial, written counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient knowledge
After counseling, patient will answer a 32 point questionnaire and this will be compared across the two groups to see there is any statistical difference between the two groups using SPSS
Measured: one year
Secondary outcomes (1)
Maternal anxiety level
Pre and post counseling administration of 6 item State and Trait anxiety inventory, SPSS software will be used to compute statistical significance
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion22 Oct 2017
- Study completion22 Oct 2017
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 Pregnancy PretermStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mopelola Akintorin, Cook County Health
- Investigators
- Mopelola Akintorin, MD, Principal investigator, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707237
- Sponsor's protocol ID
- IRB 15-226
- Status last verified
- Nov 2017
- First submitted
- 8 Feb 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Khashu M, Narayanan M, Bhargava S, Osiovich H. Perinatal outcomes associated with preterm birth at 33 to 36 weeks' gestation: a population-based cohort study. Pediatrics. 2009 Jan;123(1):109-13. doi: 10.1542/peds.2007-3743.
PubMed 19117868Govande VP, Brasel KJ, Das UG, Koop JI, Lagatta J, Basir MA. Prenatal counseling beyond the threshold of viability. J Perinatol. 2013 May;33(5):358-62. doi: 10.1038/jp.2012.129. Epub 2012 Oct 18.
PubMed 23079775Blanco F, Suresh G, Howard D, Soll RF. Ensuring accurate knowledge of prematurity outcomes for prenatal counseling. Pediatrics. 2005 Apr;115(4):e478-87. doi: 10.1542/peds.2004-1417.
PubMed 15805351Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.
PubMed 22492766Budhani S, Akintorin M, Soyemi K, Fogg L, Arlandson M, Kumar R. Maternal counseling for preterm deliveries, assessing an effective method of counseling: A randomized trial. PLoS One. 2025 Apr 9;20(4):e0294168. doi: 10.1371/journal.pone.0294168. eCollection 2025.
PubMed 40203068
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Counseling for Preterm Deliveries, Assessing an Effective Method of Counseling
- ClinicalTrials.gov ID
- NCT02707237
- Acronym / sponsor ID
- IRB 15-226
- Conditions
- Pregnancy Preterm, Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- Mar 2016
- Primary completion
- 22 Oct 2017 (actual)
- Study completion
- 22 Oct 2017 (actual)
- First posted
- 14 Mar 2016 (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.
Providing verbal counseling supplemented with both written and pictorial information then verbal counseling alone is a more effective method of counseling parents with threatened preterm delivery
Detailed description
Progress in the frontiers of neonatology has continually pushed back the limit of viability and significantly improved the survival of extremely preterm infants. An important component of medical management before a preterm delivery is counseling the parents about probabilities of survival and long term complications.
Hypothesis: Preterm counseling is more effective when parents receive verbal counseling supplemented with written and pictorial information then verbal counseling alone.
Methodology: There will be two groups of study (verbal, pictorial and written vs verbal alone). All patients admitted to the L and D department of Stroger hospital between 23 to 34 weeks of gestation with threatened premature delivery will be enrolled in the study. They will be randomly assigned to 1 of 2 groups. After counseling, parents will be asked to complete a 32 point questionnaire to check their knowledge of outcomes of prematurity.
To reach statistically significant results, the investigators will need 40 patients in each group. The study will be done over a period of one year
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal counseling | Other | Other: Verbal counselingParents with threatened delivery will receive verbal counseling only |
| Verbal, pictorial, written counseling | Other | Other: Verbal, pictorial, written counselingParents with threatened delivery will receive verbal counseling supplemented with pictorial and written information |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women between 23 to 34 weeks gestation assessed by obstetrician to need counseling
Key exclusion criteria (2 listed)
- Pregnancies with known life threatening defects considered as non compatible with life.
- Mothers previously admitted and counseled will also be excluded
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 |
|---|---|---|
| Verbal counselingVerbal counseling done by physician | Other | Verbal counseling |
| Verbal, pictorial, written counselingverbal counseling in addition to gestational age specific written information and pictures will be given to parents | Other | Verbal, pictorial, written counseling |
Primary outcome
Patient knowledge
Time frame: one year
After counseling, patient will answer a 32 point questionnaire and this will be compared across the two groups to see there is any statistical difference between the two groups using SPSS
1 secondary outcome
Maternal anxiety level
Time frame: one year
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 6 Nov 2017.
- Background: PubMed 19117868Khashu M, Narayanan M, Bhargava S, Osiovich H. Perinatal outcomes associated with preterm birth at 33 to 36 weeks' gestation: a population-based cohort study. Pediatrics. 2009 Jan;123(1):109-13. doi: 10.1542/peds.2007-3743.
- Background: PubMed 23079775Govande VP, Brasel KJ, Das UG, Koop JI, Lagatta J, Basir MA. Prenatal counseling beyond the threshold of viability. J Perinatol. 2013 May;33(5):358-62. doi: 10.1038/jp.2012.129. Epub 2012 Oct 18.
- Background: PubMed 15805351Blanco F, Suresh G, Howard D, Soll RF. Ensuring accurate knowledge of prematurity outcomes for prenatal counseling. Pediatrics. 2005 Apr;115(4):e478-87. doi: 10.1542/peds.2004-1417.
- Background: PubMed 22492766Muthusamy AD, Leuthner S, Gaebler-Uhing C, Hoffmann RG, Li SH, Basir MA. Supplemental written information improves prenatal counseling: a randomized trial. Pediatrics. 2012 May;129(5):e1269-74. doi: 10.1542/peds.2011-1702. Epub 2012 Apr 9.
- Derived from this study: PubMed 40203068Budhani S, Akintorin M, Soyemi K, Fogg L, Arlandson M, Kumar R. Maternal counseling for preterm deliveries, assessing an effective method of counseling: A randomized trial. PLoS One. 2025 Apr 9;20(4):e0294168. doi: 10.1371/journal.pone.0294168. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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.
Mopelola Akintorin, MD principal investigator
Cook County Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal counseling and Verbal, pictorial, written counseling in people with Pregnancy Preterm and Counseling, run by Cook County Health 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 2 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 6 Nov 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?
Patient knowledge (time frame: one year). 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 NCT02707237, 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 6 Nov 2017.