Pregnancy RelatedGrossesse-CxNCT05774353
Patients' Choice of Health Care Provider for Monitoring Their Pregnancy
A study testing Patient questionnaire in people with Pregnancy Related, run by Hôpital NOVO at 1 site in France.
Trial summary
The aim of this study is to understand and interpret the determinants that lead pregnant women to refer more to a health professional in order to better meet the patient's request. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Patient questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2023to 6 Jun 2023
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman in post-natal care at the NOVO hospital - Pontoise site
- Women aged 18 and over
Who cannot join
- Women who do not speak or understand French language (written and oral)
- Woman under legal protection (guardianship, curatorship...)
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Gynaecology and obstetrics department - Hospital NOVO - Pontoise site
Pontoise, 95300
About this study
The aim of this study is to understand and interpret the determinants that lead pregnant women to refer more to a health professional in order to better meet the patient's request.
Read the detailed description
Pregnancy is a natural phenomenon that occurs without complication in the majority of pregnant women. Pregnancy monitoring is necessary to detect possible complications and improve the comfort and experience of all pregnant women. For several years now, pregnant women have wanted to benefit from pregnancy monitoring as well as a less medical and physiological delivery according to the perinatal plan 2005-2007.
Perinatal plans have been implemented and evaluated for over 30 years. Progress has been made in terms of obstetrical and perinatal safety. The latest plan advocates a "humanisation of birth" which leaves more room for the parents' wishes. Pregnancy monitoring is currently carried out by doctors or midwives as part of seven compulsory prenatal examinations. This medical follow-up is completed by a preparation for birth with group classes, based on these general and obstetrical assessments.
After declaring their pregnancy, women can consult various health professionals to monitor their pregnancy. The aim of this study is to understand and interpret the determinants that lead pregnant women to be more oriented towards one health professional or another. Each determinant will be analysed and quantified in order to better respond to patient demand. The investigator chose to interview women who had just given birth and not pregnant women because the health professional may change during the course of the pregnancy, and the investigator assumes that the women will have more perspective on their experience and their choice once they have given birth.
- Conditions
- Pregnancy Related
- Being tested
- Patient questionnaire
- Keywords
- Pregnancy, Pregnancy monitoring, Healthcare professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient questionnaireOther
Patients included in the study will complete an online questionnaire (LimeSurvey).
| Study group | Role | What they receive |
|---|---|---|
| Patient questionnaire | Other | Patients included in the study will complete an online questionnaire (LimeSurvey). Receives: Other: Patient questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine which healthcare professional would be preferred by women who have just given birth, for the follow-up of their next possible pregnancy.
The healthcare professional preferred by the patients for the monitoring of their next pregnancy will be determined by the online questionnaire: question number 20.
Question 20 : In the event of a future pregnancy, which health professional would you like to be followed by? Choice of answer : Medical gynaecologist, Obstetric gynaecologist, General practitioner and Midwife.
Measured: At the end of the study, an average of 6 month
Secondary outcomes (14)
Assessment of the influence of the presence or absence of risk factors on the choice of healthcare professional
The presence or absence of risk factors (hypertension, obesity, history of premature birth, history of caesarean section, etc.) will be sought in the patient's medical file
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the acquaintance of the healthcare professional before pregnancy monitoring on the choice of healthcare professional
The evaluation of the influence of the acquaintance of the healthcare professional on the choice of the healthcare professional for the monitoring of their next pregnancy will be determined by the online questionnaire: questions number 10 and 11.
Question 10: In choosing your health care provider for your pregnancy follow-up, what are the important determinants and characteristics in your opinion? For "the acquaintance of the healthcare professional before pregnancy monitoring". Choice of answer : Not important, Not very important, Important, Very important.
Question 11: For how many years have you known the professional who has followed you the most during your pregnancy? Choice of answer : less than 5 years, between 5 and 10 years or more than 10 years.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the gender of the healthcare professional on the choice of healthcare professional
The evaluation of the influence of the gender of the health professional on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: questions number 10 and 12.
Question 10: In choosing your health care provider for your pregnancy follow-up, what are the important determinants and characteristics in your opinion? For "the gender of the healthcare professional". Choice of answer : Not important, Not very important, Important, Very important.
Question 12: Do you have a preference regarding the gender of the health professional? If so, which one? Choice of answer : No preference, Male or Femal.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the age of the healthcare professional on the choice of healthcare professional
The evaluation of the influence of the age of the health professional on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: questions number 10 and 13.
Question 10: In choosing your health care provider for your pregnancy follow-up, what are the important determinants and characteristics in your opinion? For "the age of the healthcare professional". Choice of answer : Not important, Not very important, Important, Very important.
Question 13: In your opinion, the ideal age of the health professional who follows your pregnancy is? Choice of answer : less than 40 years, between 40 and 60 years, more than 60 years or no preference.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the availability of the healthcare professional on the choice of healthcare professional
The evaluation of the influence of the availability (particularly delay to make an appointment) of the health professional on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: questions number 10 and 14.
Question 10: In choosing your health care provider for your pregnancy follow-up, what are the important determinants and characteristics in your opinion? For "the availability of the healthcare professional". Choice of answer : Not important, Not very important, Important, Very important.
Question 14: Apart from the monthly follow-up, an appointment time with the health professional is appropriate if it is? Choice of answer : within 48 hours, within 7 days or within 15 days.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the reachability of the healthcare on the choice of healthcare professional
The evaluation of the influence of the reachability of the health professional on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: questions number 10 and 15.
Question 10: In choosing your health care provider for your pregnancy follow-up, what are the important determinants and characteristics in your opinion? For "the reachability of the healthcare professional". Choice of answer : Not important, Not very important, Important, Very important.
Question 15: In choosing your health professional, a waiting period for advice is appropriate if it is? Choice of answer : within 24 hours, within 48 hours or within 7 days.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the distance from physician's office to home (or work) on the choice of healthcare professional
distance from physician's office to home (or work) on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: questions number 10 and 16.
Question 10: In choosing your health care provider for your pregnancy follow-up, what are the important determinants and characteristics in your opinion? For "the distance from physician's office to home (or work)". Choice of answer : Not important, Not very important, Important, Very important.
Question 16: In choosing your health professional, the distance from physician's office to home (or work) is appropriate if it is? Choice of answer : less than 15 minutes, between 15 and 29 minutes, between 30 and 44 minutes or more than 45 minutes.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the price of the consultation of the healthcare professional on the choice of healthcare professional
The evaluation of the influence of the price of the consultation on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: questions number 10 and 17.
Question 10: In choosing your health care provider for your pregnancy follow-up, what are the important determinants and characteristics in your opinion? For "the price of the consultation of the healthcare professional". Choice of answer : Not important, Not very important, Important, Very important.
Question 17: In choosing your health professional, the price of the consultation is appropriate if it is? Choice of answer : less than 29 euros, between 30 and 59 euros, between 60 and 89 euros or 90 euros and more.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of time spent with the healthcare professional on the choice of healthcare professional
The evaluation of the of time spent with the healthcare professional on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: questions number 10 and 18.
Question 10: In choosing your health care provider for your pregnancy follow-up, what are the important determinants and characteristics in your opinion? For "the time spent with the healthcare professional". Choice of answer : Not important, Not very important, Important, Very important.
Question 18: In choosing your health professional, the time spent with the healthcare professional is appropriate if it is? Choice of answer : less than 15 minutes, between 15 and 29 minutes, between 30 and 44 minutes or 45 minutes and more.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the healthcare professional's skills on the choice of healthcare professional
The evaluation of the influence of the healthcare professional's skills on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: questions number 10 and 19.
Question 10: For "the healthcare professional's skills". Choice of answer : Not important, Not very important, Important, Very important.
Question 19: Prioritise the most important competences of the health professional: (between 1 and 9, number 1 being the most important skill) Choice of skill : Caring attitude, empathy (does he put himself in your shoes?), Adapted and accessible communication (simple, understandable words), Diplomas/training, reliable information (without errors), Listening to the patient's wishes (shared decisions), Easily reachable professional, Patience, Pedagogy (explanations), Punctualitý and Decision-making
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the ultrasound practice in the physician's office on the choice of healthcare professional
The evaluation of the influence of ultrasound practice in the physician's office on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: question number 10.
Question 10: For "the ultrasound practice in the physician's office". Choice of answer : Not important, Not very important, Important, Very important.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the possibility of following the child after birth on the choice of healthcare professional
The evaluation of the influence of the possibility of following the child after birth on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: question number 10.
Question 10: For "the possibility of following the child after birth". Choice of answer : Not important, Not very important, Important, Very important.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the setting of the physician's office on the choice of healthcare professional
The evaluation of the influence of the setting of the physician's office (equipment, size of the office, Secretariat) on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: question number 10.
Question 10: For "the setting of the physician's office". Choice of answer : Not important, Not very important, Important, Very important.
Measured: At the end of the study, an average of 6 month
Assessment of the influence of the follow-up with the attending physician on the choice of healthcare professional
The evaluation of the influence of the follow-up with the attending physician on the choice of the health professional for the monitoring of their next pregnancy will be determined by the online questionnaire: questions number 21 to 28.
Q21: Do you have a follow-up with a general practitioner outside of pregnancy? Q22 :How old is your general practitioner? Q23 : How many years have you known him/her? Q24 :How do you feel about being treated by your general practitioner outside of pregnancy? Q25 : Does he/she practice gynaecology (screening, cervico-uterine smears, contraception...)? Q26 :Has he/she ever offered to monitor your pregnancy? Q27 :Do you think he/she is sufficiently trained in pregnancy monitoring? Q28 : In your opinion, is it the role of the general practitioner to provide gynaecological follow-up during and outside pregnancy?
Measured: At the end of the study, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start23 Mar 2023
- Primary completion6 Jun 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pr Christophe Poncelet, Principal investigator, Hospital NOVO - Pontoise site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05774353
- Sponsor's protocol ID
- CHRD0322
- Acronym
- Grossesse-Cx
- Status last verified
- Sep 2023
- First submitted
- 7 Mar 2023
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Choice of Health Care Provider for Monitoring Their Pregnancy
- ClinicalTrials.gov ID
- NCT05774353
- Acronym / sponsor ID
- Grossesse-Cx / CHRD0322
- Conditions
- Pregnancy Related
- Keywords
- Pregnancy, Pregnancy monitoring, Healthcare professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 17 Mar 2023 (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.
The aim of this study is to understand and interpret the determinants that lead pregnant women to refer more to a health professional in order to better meet the patient's request.
Detailed description
Pregnancy is a natural phenomenon that occurs without complication in the majority of pregnant women. Pregnancy monitoring is necessary to detect possible complications and improve the comfort and experience of all pregnant women. For several years now, pregnant women have wanted to benefit from pregnancy monitoring as well as a less medical and physiological delivery according to the perinatal plan 2005-2007.
Perinatal plans have been implemented and evaluated for over 30 years. Progress has been made in terms of obstetrical and perinatal safety. The latest plan advocates a "humanisation of birth" which leaves more room for the parents' wishes. Pregnancy monitoring is currently carried out by doctors or midwives as part of seven compulsory prenatal examinations. This medical follow-up is completed by a preparation for birth with group classes, based on these general and obstetrical assessments.
After declaring their pregnancy, women can consult various health professionals to monitor their pregnancy. The aim of this study is to understand and interpret the determinants that lead pregnant women to be more oriented towards one health professional or another. Each determinant will be analysed and quantified in order to better respond to patient demand. The investigator chose to interview women who had just given birth and not pregnant women because the health professional may change during the course of the pregnancy, and the investigator assumes that the women will have more perspective on their experience and their choice once they have given birth.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient questionnaire | Other | Other: Patient questionnairePatients included in the study will complete an online questionnaire (LimeSurvey). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Woman in post-natal care at the NOVO hospital - Pontoise site
- Women aged 18 and over
Key exclusion criteria (3 listed)
- Women who do not speak or understand French language (written and oral)
- Woman under legal protection (guardianship, curatorship...)
- Refusal to participate
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 |
|---|---|---|
| Patient questionnairePatients included in the study will complete an online questionnaire (LimeSurvey). | Other | Patient questionnaire |
Primary outcome
Determine which healthcare professional would be preferred by women who have just given birth, for the follow-up of their next possible pregnancy.
Time frame: At the end of the study, an average of 6 month
The healthcare professional preferred by the patients for the monitoring of their next pregnancy will be determined by the online questionnaire: question number 20. Question 20 : In the event of a future pregnancy, which health professional would you like to be followed by? Choice of answer : Medical gynaecologist, Obstetric gynaecologist, General practitioner and Midwife.
14 secondary outcomes
Assessment of the influence of the presence or absence of risk factors on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the acquaintance of the healthcare professional before pregnancy monitoring on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the gender of the healthcare professional on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the age of the healthcare professional on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the availability of the healthcare professional on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the reachability of the healthcare on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the distance from physician's office to home (or work) on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the price of the consultation of the healthcare professional on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of time spent with the healthcare professional on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the healthcare professional's skills on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the ultrasound practice in the physician's office on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the possibility of following the child after birth on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the setting of the physician's office on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
Assessment of the influence of the follow-up with the attending physician on the choice of healthcare professional
Time frame: At the end of the study, an average of 6 month
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 19 Sep 2024.
- 4\. Haut Conseil de la Santé Publique, ADSP (Actualité et dossier en santé publique) n° 61/62, Naître en France, 2007Link provided by the sponsor.
- Le plan de périnatalité 2005-2007 : humanité, proximité, sécurité, qualitéLink provided by the sponsor.
- Service Public, Grossesse : examens médicaux, 2022Link provided by the sponsor.
- La moitié des rendez-vous sont obtenus en 2 jours chez le généraliste, en 52 jours chez l'ophtalmologisteLink provided by the sponsor.
- Recommandation HAS, Comment mieux informer les femmes enceintesLink provided by the sponsor.
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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.
Pr Christophe Poncelet principal investigator
Hospital NOVO - Pontoise site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient questionnaire in people with Pregnancy Related, run by Hôpital NOVO 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 2 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 19 Sep 2024. 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?
Determine which healthcare professional would be preferred by women who have just given birth, for the follow-up of their next possible pregnancy. (time frame: At the end of the study, an average of 6 month). 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 19 Sep 2024.