Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630741
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Support and Personalized Care in Alternative Midwifery Birth Units Versus Traditional Units in France Effects on the Psychological Health of Couples and on the Health of the Mother and Child at the Age of 2 Years
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Accompagnement et Soins personnalisés Autour de la Naissance en filière Physiologique Versus filière Conventionnelle en France Effets Sur la santé Psychique Des Couples et Sur la santé de la mère et de lEnfant à lâge de 2 Ans
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PhysioCareTwo
Brief Summary:
Majority of pregnancies and childbirths in France occur without complication While the impact of care failure on maternal and neonatal morbi-mortality is now well- established the literature reveals that an overmedicalization of pregnancy and childbirth care is not associated with improved maternal and child health outcomes Conversely it could have detrimental effects in addition to representing unnecessary healthcare expenditure Recent national and international guidelines on the management of normal childbirth full-term birth without complications aim to facilitate physiological labor and minimize unnecessary medical interventions especially for women at low obstetrical risk without relevant medical history and a normal pregnancy Creating Midwifery birth units to support these pregnant women aligns with these recommendations
In France four innovative alternative midwifery units AMU devoted to management of low-risk pregnancy and natural or physiological childbirth ie without any human intervention including epidural anesthesia have been developed within hospital structures during the recent years The AMU unlike freestanding midwifery units enable a non-medicalized childbirth within a maternity hospital with immediate care available for pregnant women andor their child in cases of life-threatening emergencies AMU co-exist in the same building on the same site as a hospital or host obstetric unit within conventional obstetric units but with dedicated and separate spaces Personalized follow-up starting from the early stages of pregnancy and birth and parenthood preparation classes are provided by a designated midwife and are offered to couples wishing to without any fee exceeding the standard medical charges Delivery takes place in a birthing room with specific and not medicalized equipment
Available studies in France and abroad suggest that home births or birth in freestanding midwifery units do not increase perinatal morbidity They may enhance the childbirth experience positively influencing the establishment of the mother-child bond and the psychological well-being of parents in the PostPartum PP period which in turn can impact the short- and long-term child development Professional support provided by midwives is crucial throughout this period pregnancy delivery and PP benefiting both the pregnant woman and the future father A positive birth experience can therefore strengthen self-confidence and be decisive for family unit cohesion In addition two recent studies have shown that a traumatic birth experience is strongly correlated with PP depression in both parents and difficulties in the mother-child bond This lead to the conclusion that personalised and special support offer to couples during this experience of parenthood which could involve the development of midwives-led birth units A recent meta-analysis also encourages further research that would provide insights into the long-term effects of global perinatal care particularly on mother-child interaction and PP depression
The PhysioCare study end in July 2023 aimed to investigate the impact of such care on womens psychological health during the first six weeks following childbirth However no study has examined the long-term effects on mental health beyond the immediate PP period PhysioCareTwo will serve as the continuation of the PhysioCare research project Principal Investigator R GARLANTEZEC This research has been conducted in three French centers with follow-up assessments extending up to six weeks PP Inclusion for this previous project began on 01092022 and ended on 29042023 This is the first French study to address this issue and to evaluate care units such as AMU with the participation of 3 out of 4 maternity units in France offering this kind of care
The coexistence of standard obstetric units SOU and AMU within the same maternity unit provides an opportunity to assess the impact of this innovative care approach PhysioCareTwo will enable the ongoing followed up of couples beyond the initial 6 weeks PP with an assessment of the mental well-being of both mothers and co-parents two years after childbirth
Providing AMU care to women with low obstetrical risk as compared to standard birth care units could enhance the psychological well-being of parents in both the short and long term
In France four innovative alternative midwifery units AMU devoted to management of low-risk pregnancy and natural or physiological childbirth ie without any human intervention including epidural anesthesia have been developed within hospital structures during the recent years The AMU unlike freestanding midwifery units enable a non-medicalized childbirth within a maternity hospital with immediate care available for pregnant women andor their child in cases of life-threatening emergencies AMU co-exist in the same building on the same site as a hospital or host obstetric unit within conventional obstetric units but with dedicated and separate spaces Personalized follow-up starting from the early stages of pregnancy and birth and parenthood preparation classes are provided by a designated midwife and are offered to couples wishing to without any fee exceeding the standard medical charges Delivery takes place in a birthing room with specific and not medicalized equipment
Available studies in France and abroad suggest that home births or birth in freestanding midwifery units do not increase perinatal morbidity They may enhance the childbirth experience positively influencing the establishment of the mother-child bond and the psychological well-being of parents in the PostPartum PP period which in turn can impact the short- and long-term child development Professional support provided by midwives is crucial throughout this period pregnancy delivery and PP benefiting both the pregnant woman and the future father A positive birth experience can therefore strengthen self-confidence and be decisive for family unit cohesion In addition two recent studies have shown that a traumatic birth experience is strongly correlated with PP depression in both parents and difficulties in the mother-child bond This lead to the conclusion that personalised and special support offer to couples during this experience of parenthood which could involve the development of midwives-led birth units A recent meta-analysis also encourages further research that would provide insights into the long-term effects of global perinatal care particularly on mother-child interaction and PP depression
The PhysioCare study end in July 2023 aimed to investigate the impact of such care on womens psychological health during the first six weeks following childbirth However no study has examined the long-term effects on mental health beyond the immediate PP period PhysioCareTwo will serve as the continuation of the PhysioCare research project Principal Investigator R GARLANTEZEC This research has been conducted in three French centers with follow-up assessments extending up to six weeks PP Inclusion for this previous project began on 01092022 and ended on 29042023 This is the first French study to address this issue and to evaluate care units such as AMU with the participation of 3 out of 4 maternity units in France offering this kind of care
The coexistence of standard obstetric units SOU and AMU within the same maternity unit provides an opportunity to assess the impact of this innovative care approach PhysioCareTwo will enable the ongoing followed up of couples beyond the initial 6 weeks PP with an assessment of the mental well-being of both mothers and co-parents two years after childbirth
Providing AMU care to women with low obstetrical risk as compared to standard birth care units could enhance the psychological well-being of parents in both the short and long term
Detailed Description:
Method and Material
Couples included in the prospective multi-center observational PhysioCare study 3 centers exposedunexposed12 ratio 1 woman in AMU for 2 in SOU matched by center and parity will be invited to complete standardized questionnaires online 2 years after birth City Birth Trauma Scale Edinburgh Postnatal Depression Scale generic SF-12 questionnaire Mother-to-Infant Bonding scale Questionnaire dAuto-Evaluation de la Compétence Educative Parentale Multidimensional Scale of Perceived Social Support Child Development Inventory short version data on breastfeeding and health Estimated sample size at 2 years with 70 of respondents 420 women 328 coparents Semi-structured interviews to assess womens partners and professionals perceptions of care will be conducted on a sample of couples Multivariate intention-to-treat statistical analyses linearlogistic regression with propensity score IPTW will be performed
Findings expected
PhysioCareTwo study has the potential to produce significant results that improve maternal and child health strengthen medical practices and promote family well-being These spin-offs can have a positive impact in the short medium and long term in the perinatal field
Conclusion
To generate concrete knowledge for the benefit of parents and their children improve perinatal care in France and promote these care approach
Couples included in the prospective multi-center observational PhysioCare study 3 centers exposedunexposed12 ratio 1 woman in AMU for 2 in SOU matched by center and parity will be invited to complete standardized questionnaires online 2 years after birth City Birth Trauma Scale Edinburgh Postnatal Depression Scale generic SF-12 questionnaire Mother-to-Infant Bonding scale Questionnaire dAuto-Evaluation de la Compétence Educative Parentale Multidimensional Scale of Perceived Social Support Child Development Inventory short version data on breastfeeding and health Estimated sample size at 2 years with 70 of respondents 420 women 328 coparents Semi-structured interviews to assess womens partners and professionals perceptions of care will be conducted on a sample of couples Multivariate intention-to-treat statistical analyses linearlogistic regression with propensity score IPTW will be performed
Findings expected
PhysioCareTwo study has the potential to produce significant results that improve maternal and child health strengthen medical practices and promote family well-being These spin-offs can have a positive impact in the short medium and long term in the perinatal field
Conclusion
To generate concrete knowledge for the benefit of parents and their children improve perinatal care in France and promote these care approach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None