Preterm BirthNCT01974531
Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study
An observational study of Preterm Birth and Pregnancy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of the present prospective study is the analysis of risk and protective factors of perinatal stress and psychological distress of parents with or without a preterm child. Stress is measured biologically by Cortisol levels and psychologically by a questionnaire. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Pregnancy, Stress
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Dec 2019
- How long will I take part?
- 2 Years
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: pregnant women either with risk of with no risk of preterm birth from the obstetric ward or from the antenatal class of the obstetric department and their partners
Who may be able to join
- pregnant women and their partners from the 24th week of gestation on
- 18 years of age
Who cannot join
- psychiatric, mainly psychotic diseases
- drug abuse
- severe neurological disorders
- stillbirth
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Frankfurt-Dept.Obstetrics and Perinatal Medicine
Frankfurt am Main, Hesse, 60590
About this study
Official title: Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study on Risk and Protective Psychobiological Aspects
The purpose of the present prospective study is the analysis of risk and protective factors of perinatal stress and psychological distress of parents with or without a preterm child. Stress is measured biologically by Cortisol levels and psychologically by a questionnaire. Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress disorder, burnout) are measured by various questionnaires. We analyze the influence of different aspects as personality traits, social support, partnership.
- Conditions
- Preterm Birth, Pregnancy, Stress, Psychological Distress
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm birth/ Timely birth | Not described | |
| Women/men | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Goethe University
- Responsible party
- Principal investigator, Dr. Silvia Oddo, Johann Wolfgang Goethe University Hospital
- Investigators
- Frank Louwen, Prof., Study director, University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974531
- Sponsor's protocol ID
- Louwen/Oddo-Preterm birth
- Status last verified
- Feb 2022
- First submitted
- 28 Oct 2013
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Pernidaki V, Schermelleh-Engel K, Sommerlad S, Louwen F, Oddo-Sommerfeld S. Fathers at risk: Effects of threatened and actual preterm birth on the course of paternal peripartum depression and anxiety. PLoS One. 2026 Sep 9;21(9):e0356746. doi: 10.1371/journal.pone.0356746. eCollection 2026.
PubMed 42715170Sommerlad S, Schermelleh-Engel K, La Rosa VL, Louwen F, Oddo-Sommerfeld S. Trait anxiety and unplanned delivery mode enhance the risk for childbirth-related post-traumatic stress disorder symptoms in women with and without risk of preterm birth: A multi sample path analysis. PLoS One. 2021 Aug 31;16(8):e0256681. doi: 10.1371/journal.pone.0256681. eCollection 2021.
PubMed 34464408
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study on Risk and Protective Psychobiological Aspects
- ClinicalTrials.gov ID
- NCT01974531
- Acronym / sponsor ID
- Louwen/Oddo-Preterm birth
- Conditions
- Preterm Birth, Pregnancy, Stress, Psychological Distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Goethe University
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 1 Nov 2013 (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 purpose of the present prospective study is the analysis of risk and protective factors of perinatal stress and psychological distress of parents with or without a preterm child. Stress is measured biologically by Cortisol levels and psychologically by a questionnaire. Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress disorder, burnout) are measured by various questionnaires. We analyze the influence of different aspects as personality traits, social support, partnership.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm birth/ Timely birth | – | – |
| Women/men | – | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant women either with risk of with no risk of preterm birth from the obstetric ward or from the antenatal class of the obstetric department and their partners
Key inclusion criteria (2 listed)
- pregnant women and their partners from the 24th week of gestation on
- 18 years of age
Key exclusion criteria (4 listed)
- psychiatric, mainly psychotic diseases
- drug abuse
- severe neurological disorders
- stillbirth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
stress
Time frame: two years
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 2 Mar 2022.
- Derived from this study: PubMed 42715170Pernidaki V, Schermelleh-Engel K, Sommerlad S, Louwen F, Oddo-Sommerfeld S. Fathers at risk: Effects of threatened and actual preterm birth on the course of paternal peripartum depression and anxiety. PLoS One. 2026 Sep 9;21(9):e0356746. doi: 10.1371/journal.pone.0356746. eCollection 2026.
- Derived from this study: PubMed 34464408Sommerlad S, Schermelleh-Engel K, La Rosa VL, Louwen F, Oddo-Sommerfeld S. Trait anxiety and unplanned delivery mode enhance the risk for childbirth-related post-traumatic stress disorder symptoms in women with and without risk of preterm birth: A multi sample path analysis. PLoS One. 2021 Aug 31;16(8):e0256681. doi: 10.1371/journal.pone.0256681. eCollection 2021.
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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.
Frank Louwen, Prof. study director
University Hospital Frankfurt-Dept. Obstetrics and Perinatal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth and Pregnancy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 2 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 2 Mar 2022. 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 Germany. 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?
stress (time frame: two years). 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 NCT01974531, which also lists 2 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 2 Mar 2022.