Brief description of trial (Data source: BASEC)
Frauen, die ihr erstes Kind gebären, haben oft Mühe mit den Wehen und Beschwerden der Latenzphase, d.h. der ersten Phase der Geburt, umzugehen. Erfolgt der Spitaleintritt bevor die Geburt voranschreitet, ist dies mit erhöhten Interventions- und Kaiserschnittraten verbunden. Mit Wehen zu Hause bleiben kann jedoch grosse Ängste auslösen. Die Betreuung in der Latenzphase ist für die Gebärenden oft unbefriedigend und für die Gesundheitsfachpersonen eine Herausforderung.
Deshalb wurde in dieser Studie ein Fragebogen entwickelt und geprüft, der ermöglicht, wissenschaftlich fundiert und individuell den körperlichen sowie emotionalen Zustand von Gebärenden in der Latenzphase zu beurteilen. Damit kann das Betreuungsbedürfnis der Frauen ermittelt und die Beratung für oder gegen eine Aufnahme ins Spital unterstützt werden. Neben den Gütekriterien des Fragebogens wurde die Zufriedenheit der Frauen, Hebammen und Ärzt:innen mit der Anwendung des Instruments untersucht. Die Datenerhebung erfolgte in Zusammenarbeit mit sechs Schweizer Spitälern.
Der neu entwickelte standardisierte Fragebogen kann von Gesundheitsfachpersonen beim telefonischen oder persönlichen Erstkontakt mit Erstgebärenden angewendet werden.
Health conditions investigated(Data source: BASEC)
Frauen, die ihr erstes Kind bekommen sind verunsichert, wann sie ins Spital eintreten sollen.
Health conditions
(Data source: WHO)
O80;Single spontaneous delivery
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Anwendung eines neu entwickelten standardisierten Fragebogens
Interventions
(Data source: WHO)
Group 1: Application of the preliminary tool (standardised questionnaire) at the first contact with primiparous women during early labour for childbirth. The midwife or the obstetrician asked standardised questions during the telephone or face-to-face contact with the parturient. The assessment resulted in a score, which advised the decision for or against hospital asmission. For the validation of certain items of the newly developed tool, they were compared with items of the German versions of the Cambridge Worry Scale and the Childbirth Self-Efficacy Inventory.
Criteria for participation in trial
(Data source: BASEC)
• Schwangere Frauen über 18 Jahre
• Erstes Kind
• Kein Kaiserschnitt geplant
Exclusion criteria
(Data source: BASEC)
• Ungenügende mündliche und schriftliche Deutschkenntnisse
• Mehrlingsschwangerschaft
• Kind nicht in Kopflage
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: Female
Maximum age: None
Minimum age: 18 Years
Inclusion criteria: ?Pregnant women = 18 years old
?Sufficient oral and written German language knowledge
?Expecting the first child
?Singleton
?Cephalic presentation
?No elective caesarean section planned
?No labour induction planned
Exclusion criteria: ?Pregnant women expecting their second child or more
?Multiple pregnancy
?Elective caesarean section or labour induction planned
-
Further information on trial
Date trial registered
Jul 28, 2021
Incorporation of the first participant
Mar 1, 2022
Recruitment status
Complete
Academic title
(Data source: WHO)
Development and validation of a tool for advising primiparous women during early labour (GebStart-Study) - GebStart-Study
Type of trial
(Data source: WHO)
interventional
Design of the trial
(Data source: WHO)
Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: prevention
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
The primary outcome of the study were the quality criteria of the tool (standardised questionnaire).
Secundary end point
(Data source: WHO)
Secondary outcomes were: 1) Mothers: perinatal outcomes such as mode of birth, interventions during childbirth, perineal injuries, breastfeeding, hospital stay, postnatal quality of life, satisfaction with the application of the tool, satisfaction with the care received, 2) Infants: Birth weight, Apgar-Score, umbilical cord pH, admission to NICU, 3) Health professionals: satisfaction with the application of the tool.
Contact information
(Data source: WHO)
Schweizerischer Nationalfonds
Trial results
(Data source: WHO)
Results summary
no information available yet
Information on the availability of individual participant data
Yes
Health-related data is considered to be sensitive personal data by the Swiss Federal Act on Data Protection. Thus, procedures have also to comply with the current GCP standards and the Human Research Act of Switzerland. Primary owner of all data collected in this study are the participants that participate herein. In order to use their data for scientific research, approval by the participants and by an ethical committee has to been obtained. Data can only be shared with third parties after this approval. Following the FAIR data principles, FORSbase and DaSCH and maybe further repositories will be evaluated during the project as potential repositories for the publication of approved and anonymised data. Approved and anonymised data will be shared with the final scientific publications related to the respective data.
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Baden, Basel, Luzern, Winterthur, Zurich
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Susanne Grylka
+41 58 934 43 77
susanne.grylka@zhaw.ch
Contact for general information
(Data source: WHO)
Susanne
Grylka-Baeschlin
Katharina-Sulzer-Platz 9
Z?rcher Hochschule f?r Angewandte Wissenschaften, Departement Gesundheit, Institut f?r Hebammenwissenschaft und reproduktive Gesundheit
+41 58 934 43 77
susanne.grylka@zhaw.ch
Contact for scientific information
(Data source: WHO)
Susanne
Grylka-Baeschlin
Katharina-Sulzer-Platz 9
Z?rcher Hochschule f?r Angewandte Wissenschaften, Departement Gesundheit, Institut f?r Hebammenwissenschaft und reproduktive Gesundheit
+41 58 934 43 77
susanne.grylka@zhaw.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
27.07.2021
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2021-00687
Secondary ID (Data source: WHO)
SNCTP000004555
PT00P1_199085
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