Study of the Prevalence of Complications Occurring in the Mother-newborn Couple During the First … (NCT03114930) | Clinical Trial Compass
CompletedNot Applicable
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
France177 participantsStarted 2016-03-30
Plain-language 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.
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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The occurrence of complications in the first month of life in the "mother-newborn" couple.