ParturitionESPT ObstNCT03441243
Evaluation of the Psychological Consequences of Complicated Childbirth
An observational study of Parturition, run by Rennes University Hospital at 1 site in France.
Trial summary
Prospective, non-interventional, monocentric, case-control study Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Parturition
- How many people
- 256 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2018to 27 Feb 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who gave birth between 01/01/2015 and 31/12/2017
Who may be able to join
- Major patients ;
- Who had hemorrhage of the transfused delivery between 01/01/2015 and 31/12/2017 or an emergency cesarean section between 01/01/2015 and 31/12/2016 or patients who gave birth physiologically paired with age, date of delivery and parity ;
- Patients who did not express their opposition to participate in the study.
Who cannot join
- Minor patients;
- Patients who do not speak and understand French;
- Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospital-University Psychiatry Center for Children and Adolescents
Rennes, Britanny, 35000
About this study
Prospective, non-interventional, monocentric, case-control study
Read the detailed description
The post-traumatic stress state affects up to 6.2% of patients at 2 months post partum.
Emergency cesarean section and rescue hemorrhage are identified risk factors for postpartum stress disorder or postpartum depression.
These complications (emergency cesarean section and hemorrhage of delivery) alter the mother-child relationship and cognitive development of the child.
The experience of an emergency Cesarean section or a haemorrhage of deliverance generates apprehension about a subsequent pregnancy. Some patients abandon a future pregnancy project for fear of reliving these experiences.
Currently, at the southern hospital, the risk factors for developing a state of post-traumatic stress are not sought by the care teams. No specific follow-up is planned for patients who have had an emergency caesarean section or hemorrhage of delivery.
The investigators wish to study the psychological consequences of emergency cesarean section and rescue haemorrhage, the risk factors for post-traumatic stress disorder after emergency cesarean section or hemorrhage of delivery, and their consequences on the mother-child relationship to better identify situations at risk of psychological trauma and provide appropriate care for patients (consultation with a postpartum psychologist).
- Conditions
- Parturition
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 |
|---|---|---|
| Case group:Cesarean section urgently | - 43 patients had an emergency caesarean section between 01/01/2015 and 31/12/2016. | |
| Case group:Hemorrhage of deliverance | - 85 patients had haemorrhage of the delivery with need for a transfusion between 01/01/2015 and 31/12/2017. | |
| Control group: delivery physiological low path | - A control group will consist of 128 patients who had a physiological low birth delivery over the same period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic stress
Post traumatic stress state score according to the PCL-5 (Posttraumatic Stress Disorder Checklist-5)
Measured: Baseline
Secondary outcomes (4)
Tocophobia
Tocophobia score according to the Tocophobia Questionnaire
Measured: Baseline
Peritraumatric dissociation
Peritraumatric dissociation score according to the PDEQ (Peritraumatric dissociative Expériences Questionnaire)
Measured: Baseline
Postpartum depression
Postpartum depression score according to the Edingburgh Perinatal Depression Questionnaire
Measured: Baseline
Mother-child relationship
Mother-child Relationship score according to the Parent Bonding Questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start23 May 2018
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParturitionStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Dayan, Principal investigator, Hospital-University Psychiatry Center for Children and Adolescents
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441243
- Sponsor's protocol ID
- 35RC18_3096_ESPT Obst
- Acronym
- ESPT Obst
- Status last verified
- Mar 2020
- First submitted
- 15 Feb 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Psychological Consequences of Complicated Childbirth
- ClinicalTrials.gov ID
- NCT03441243
- Acronym / sponsor ID
- ESPT Obst / 35RC18_3096_ESPT Obst
- Conditions
- Parturition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 23 May 2018 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 22 Feb 2018 (actual)
- 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.
Prospective, non-interventional, monocentric, case-control study
Detailed description
The post-traumatic stress state affects up to 6.2% of patients at 2 months post partum.
Emergency cesarean section and rescue hemorrhage are identified risk factors for postpartum stress disorder or postpartum depression.
These complications (emergency cesarean section and hemorrhage of delivery) alter the mother-child relationship and cognitive development of the child.
The experience of an emergency Cesarean section or a haemorrhage of deliverance generates apprehension about a subsequent pregnancy. Some patients abandon a future pregnancy project for fear of reliving these experiences.
Currently, at the southern hospital, the risk factors for developing a state of post-traumatic stress are not sought by the care teams. No specific follow-up is planned for patients who have had an emergency caesarean section or hemorrhage of delivery.
The investigators wish to study the psychological consequences of emergency cesarean section and rescue haemorrhage, the risk factors for post-traumatic stress disorder after emergency cesarean section or hemorrhage of delivery, and their consequences on the mother-child relationship to better identify situations at risk of psychological trauma and provide appropriate care for patients (consultation with a postpartum psychologist).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Case group:Cesarean section urgently | – | –- 43 patients had an emergency caesarean section between 01/01/2015 and 31/12/2016. |
| Case group:Hemorrhage of deliverance | – | –- 85 patients had haemorrhage of the delivery with need for a transfusion between 01/01/2015 and 31/12/2017. |
| Control group: delivery physiological low path | – | –- A control group will consist of 128 patients who had a physiological low birth delivery over the same period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who gave birth between 01/01/2015 and 31/12/2017
Key inclusion criteria (3 listed)
- Major patients ;
- Who had hemorrhage of the transfused delivery between 01/01/2015 and 31/12/2017 or an emergency cesarean section between 01/01/2015 and 31/12/2016 or patients who gave birth physiologically paired with age, date of delivery and parity ;
- Patients who did not express their opposition to participate in the study.
Key exclusion criteria (3 listed)
- Minor patients;
- Patients who do not speak and understand French;
- Major persons subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty.
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
Post-traumatic stress
Time frame: Baseline
Post traumatic stress state score according to the PCL-5 (Posttraumatic Stress Disorder Checklist-5)
4 secondary outcomes
Tocophobia
Time frame: Baseline
Peritraumatric dissociation
Time frame: Baseline
Postpartum depression
Time frame: Baseline
Mother-child relationship
Time frame: Baseline
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 3 Mar 2020.
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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.
Jacques Dayan principal investigator
Hospital-University Psychiatry Center for Children and Adolescents
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 Parturition, run by Rennes University Hospital at 1 site in France.
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 3 inclusion and 3 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 3 Mar 2020. 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 France. 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?
Post-traumatic stress (time frame: Baseline). 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 3 Mar 2020.