- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01793558
Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section (THER5)
Study That Evaluates the Incidence and Possibilities for Prevention of Hypothermia in Newborns Bonding During Caesarean Section
This study should evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest.
Therefore, the investigators want to investigate the effects of active cutaneous warming of the mothers and babies during intraoperative bonding. The investigators plan to enroll 40 parturients scheduled for elective caesarean section to receive passive insulation or forced-air skin surface warming. The investigators will measure core temperature of the newborns and their mothers. The investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Schleswig-Holstein
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Pinneberg, Schleswig-Holstein, Tyskland, 25421
- Klinikum Pinneberg Klinik für Anästhesiologie, Intensivmedizin und OP-Management
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- parturients undergoing planned, elective cesarean section under spinal anaesthesia
- mothers classified as American Society of Anaesthesiologists (ASA) status I or II
- written informed consent
Exclusion Criteria:
- mothers younger than 18 years
- mothers classified as American Society of Anaesthesiologists (ASA) status III or higher
- caesarean section planned under general anaesthesia.
any expected problems with the newborn such as:
- gestation date < 36 or > 42 week
- placenta previa, abruption of placenta, green amniotic fluid, amnion infection syndrome or any abnormalities in cardiotocography (CTG)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Control; passive insulation
The mothers will receive passive temperature insulation by a cotton blanket (standard procedure) after start of the spinal anaesthesia for cesarean section.
The newborn will be bonded on the mothers chest under the cotton blanket (also passive insulation without active warming) for 20 min after birth (bonding period).
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Eksperimentel: Active Warming
The mothers will receive active warming by a forced-air warming blanket after start of the spinal anaesthesia for cesarean section.
The newborn will be bonded on the mothers chest under the warming blanket for 20 min after birth (bonding period).
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In the intervention group a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the upper body of the patients laying on the operating table just beginning after the spinal block.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Body core temperature of the newborn
Tidsramme: 20 min after birth
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Core temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period)by a rectal temperature probe.
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20 min after birth
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Skin temperature of the newborn
Tidsramme: 20 min after child birth
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Skin temperature of the infants will be measured with specific probes 20 min after birth (end of bonding period) at chest, arm, thigh, and calf.
Mean-skin temperature will be calculated from these measurements.
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20 min after child birth
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Shivering incidence of the mothers
Tidsramme: 20 min after child birth
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Shivering of the mothers will be graded by a four-point scale.
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20 min after child birth
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Thermal comfort of the mothers
Tidsramme: 20 min after child birth
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Thermal comfort of the mother will be evaluated with a 100-mm visual analogue scale.
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20 min after child birth
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Mean arterial blood pressure of the mothers.
Tidsramme: 20 min after child birth
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Mean arterial blood pressure of the mothers will be assessed by non-invasive measurement.
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20 min after child birth
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Core temperature of the mothers
Tidsramme: 20 min after child birth
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Core temperature will be measured by a sublingual temperature probe.
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20 min after child birth
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Skin temperature of the mothers.
Tidsramme: 20 min after child birth
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Skin temperature of the mothers will be assessed at the chest.
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20 min after child birth
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Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Berthold Bein, M.D., University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- THER-5
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