Mother-Child RelationsCOMPLISTANNCT03114930
Study of the Prevalence of Complications Occurring in the Mother-newborn Couple During the First Month After Returning Home, Since the Introduction of Standard Outpatients (According to HAS 2014 Recommendations) at the Amiens-Picardie University Hospital
A study testing To study the absence of increased complications and events occurring in the "mother-newborn" in people with Mother-Child Relations and Maternity, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Prior to the HAS recommendations of March 2014, the "mother - newborn" couple was discharged from the maternity home at 4 days after delivery by AVB and 5 days after caesarean section. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Mother-Child Relations, Maternity
- What is being tested?
- To study the absence of increased complications and events occurring in the "mother-newborn"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2016to 1 Dec 2018
- 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
- Be taken care of in the Maternity Department of the Amiens-Picardie University Hospital.
- Parents' agreement
- Mother and Newborn who meet the eligibility criteria of the HAS for a "standard" exit.
- Mother :
- 1. Absence of a situation of psychological, social vulnerability, behaviors of addiction and severe dependencies
- 2. Adequate family and / or social support
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- 3. Absence of chronic ill-balanced pathology
- 4. Absence of complications or pathologies requiring observation or continuous medical treatment
- 5. Absence of haemorrhage of the delivery, this one was checked and treated (if necessary)
- 6. Absence of active infection or signs of infection
- 7. Absence of thromboembolic signs
- 8. Controlled Pain
- 9. Satisfactory mother-child interactions
- Child:
- 1. Newborn at term ≥ 37 weeks of amenorrhea, singleton and eutroph
- 2. Normal clinical examination performed imperatively 48 hours after birth and before discharge
- 3. Axillary temperature between 36 and 37 ° C or central between 36.5 and 37.5 ° C
- 4. Established feeding (if breastfeeding: observation of at least 2 feeds ensuring effective transfer of colostrum / milk recognized by the mother), urination and spontaneous stool emissions, established transit
- 5. Weight loss <8% of birth weight
- 6. Absence of jaundice requiring phototherapy according to the therapeutic indication curve and measurement of transcutaneous and / or blood bilirubin at the output referred to the nomogram (low risk and low intermediate risk only)
- 7. Lack of clinical or paraclinical evidence for infection; If risk factors of infection: recovered and negative biological and bacteriological samples
- 8. Planned neonatal screening and traceability
- 9. Post-partum follow-up after the organized event: an appointment with a referral professional within 48 hours following the exit or even in the week
Who cannot join
- Patient not speaking French
- Patient who does not meet the HAS criteria: newborn or ineligible mother (minor mother, non-singleton birth)
- Assumption in another department than the Maternity department of the CHU Amiens-Picardie.
Trial locations and contacts
1 site in 1 country.
About this study
Prior to the HAS recommendations of March 2014, the "mother - newborn" couple was discharged from the maternity home at 4 days after delivery by AVB and 5 days after caesarean section.
The stay in maternity allowed a follow-up of the newborn whose weight gain and the occurrence of a jaundice; And monitoring of the mother whose milky ascent and psychological feelings.
Read more
In March 2014, the HAS published new recommendations on maternity leave arrangements for the "mother - newborn" couple, the organization of postpartum follow - up for the mother and pediatric follow - up for the newborn. The HAS then defines so-called "optimal" conditions for so-called "standard" outputs, with 9 criteria to respect respectively for the mother and the newborn.
If the mother-to-newborn couple respects these so-called optimal conditions and is eligible according to the respective criteria, the latter leaves at home after 72 hours and before 96 hours for an AVB and after 96 completed hours and Before 120 hours for caesarean delivery.
As no pediatric discharge was done in the afternoons at the maternity hospital of Amiens, an arbitrary choice was made to allow a "standard" release to the "mother-newborn" couple only if the child was born between 00H00 and 11H59 so that his clinical examination of exit is carried out at 72 hours of the birth as recommended by the recommendations of the HAS.
These recommendations being recent (2014), no study has studied the impact and consequences on the triad "father / mother-newborn" of these exits including the occurrence of possible complications or events: re-hospitalizations again The early termination of breastfeeding, and whether the follow-up procedures advocated by the HAS are being followed.
- Conditions
- Mother-Child Relations, Maternity
- Being tested
- To study the absence of increased complications and events occurring in the "mother-newborn"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To study the absence of increased complications and events occurring in the "mother-newborn"Other
To study the absence of increased complications and events occurring in the "mother-newborn" couple who made a "standard" exit compared to the "mother-newborn" couples who had benefited from an extra day of " Hospitalization in maternity.
| Study group | Role | What they receive |
|---|---|---|
| Standard output | Other | Not described Receives: Other: To study the absence of increased complications and events occurring in the "mother-newborn" |
| Non standard output | Other | Not described Receives: Other: To study the absence of increased complications and events occurring in the "mother-newborn" |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of complications in the first month of life in the "mother-newborn" couple.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start30 Mar 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother-Child RelationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114930
- Sponsor's protocol ID
- PI2015_843_0023
- Acronym
- COMPLISTAN
- Status last verified
- Nov 2025
- First submitted
- 4 Apr 2017
- Last updated
- 19 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Complications Occurring in the Mother-newborn Couple During the First Month After Returning Home, Since the Introduction of Standard Outpatients (According to HAS 2014 Recommendations) at the Amiens-Picardie University Hospital
- ClinicalTrials.gov ID
- NCT03114930
- Acronym / sponsor ID
- COMPLISTAN / PI2015_843_0023
- Conditions
- Mother-Child Relations, Maternity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 30 Mar 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 14 Apr 2017 (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.
Prior to the HAS recommendations of March 2014, the "mother - newborn" couple was discharged from the maternity home at 4 days after delivery by AVB and 5 days after caesarean section.
The stay in maternity allowed a follow-up of the newborn whose weight gain and the occurrence of a jaundice; And monitoring of the mother whose milky ascent and psychological feelings.
In March 2014, the HAS published new recommendations on maternity leave arrangements for the "mother - newborn" couple, the organization of postpartum follow - up for the mother and pediatric follow - up for the newborn. The HAS then defines so-called "optimal" conditions for so-called "standard" outputs, with 9 criteria to respect respectively for the mother and the newborn.
If the mother-to-newborn couple respects these so-called optimal conditions and is eligible according to the respective criteria, the latter leaves at home after 72 hours and before 96 hours for an AVB and after 96 completed hours and Before 120 hours for caesarean delivery.
As no pediatric discharge was done in the afternoons at the maternity hospital of Amiens, an arbitrary choice was made to allow a "standard" release to the "mother-newborn" couple only if the child was born between 00H00 and 11H59 so that his clinical examination of exit is carried out at 72 hours of the birth as recommended by the recommendations of the HAS.
These recommendations being recent (2014), no study has studied the impact and consequences on the triad "father / mother-newborn" of these exits including the occurrence of possible complications or events: re-hospitalizations again The early termination of breastfeeding, and whether the follow-up procedures advocated by the HAS are being followed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard output | Other | Other: To study the absence of increased complications and events occurring in the "mother-newborn" |
| Non standard output | Other | Other: To study the absence of increased complications and events occurring in the "mother-newborn" |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (23 listed)
- Be taken care of in the Maternity Department of the Amiens-Picardie University Hospital.
- Parents' agreement
- Mother and Newborn who meet the eligibility criteria of the HAS for a "standard" exit.
- 1. Absence of a situation of psychological, social vulnerability, behaviors of addiction and severe dependencies
- 2. Adequate family and / or social support
Key exclusion criteria (3 listed)
- Patient not speaking French
- Patient who does not meet the HAS criteria: newborn or ineligible mother (minor mother, non-singleton birth)
- Assumption in another department than the Maternity department of the CHU Amiens-Picardie.
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 |
|---|---|---|
| To study the absence of increased complications and events occurring in the "mother-newborn"To study the absence of increased complications and events occurring in the "mother-newborn" couple who made a "standard" exit compared to the "mother-newborn" couples who had benefited from an extra day of " Hospitalization in maternity. | Other | Non standard output, Standard output |
Primary outcome
The occurrence of complications in the first month of life in the "mother-newborn" couple.
Time frame: 1 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 Nov 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing To study the absence of increased complications and events occurring in the "mother-newborn" in people with Mother-Child Relations and Maternity, run by Centre Hospitalier Universitaire, Amiens 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 23 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 Nov 2025. 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?
The occurrence of complications in the first month of life in the "mother-newborn" couple. (time frame: 1 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 Nov 2025.