- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07641751
Effect of Husband Attendance on Anesthesia Performance and Maternal-Neonatal Outcomes During Elective Cesarean Section Under Spinal Anesthesia
7. juni 2026 opdateret af: Alexandria University
Effect of Husband Attendance on Anesthesia Performance and Maternal-Neonatal Outcomes During Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial
Family-centered perinatal care has become an integral component of modern obstetric practice, emphasizing emotional support and shared parental experiences during childbirth.
The presence of an additional individual in the operating room may influence workflow dynamics, potentially introducing distractions or compromising adherence to sterile protocols.
These factors could theoretically affect anesthesia administration, surgical timing, and perioperative safety.
Conversely, emotional support from the husband may reduce maternal anxiety, improve overall experience, and indirectly influence physiological responses during surgery.
Studieoversigt
Status
Tilmelding efter invitation
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
100
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
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Alexandria, Egypten
- medical research institute , Alexandrria university
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Eligible participants will include primiparous and multiparous women scheduled for elective cesarean section under spinal anesthesia, performed by experienced anesthesiologists.
Exclusion Criteria:
- contraindication of spinal anesthesia
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Husband Attendance Group
Husbands will be allowed to attend the cesarean section procedure, providing emotional support to their partners.
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Husbands will be allowed to attend the cesarean section procedure, providing emotional support to their partners.
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Eksperimentel: No Attendance Group
Husbands will not be permitted to attend the cesarean section procedure
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Husbands will not be permitted to attend the cesarean section procedure
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Anesthesia Administration
Tidsramme: intraoperative period
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we will assess the efficiency and accuracy of anesthesia administration during cesarean sections with husband attendance.
Measure factors such as induction time in minutes.
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intraoperative period
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Surgical Delays
Tidsramme: intraoperative period
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we will evaluate whether the presence of the husband during the procedure affects the surgical workflow or leads to any delays in anesthesia delivery or surgical start times in minutes.
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intraoperative period
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Complications
Tidsramme: intraoperative period
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we will examine the occurrence of anesthesia-related complications, such as hypotension, hypoxia, or allergic reactions, and determine if there is any association with the presence of the husband in the operating room.
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intraoperative period
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Sterility and Infection Control
Tidsramme: perioperative period
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we will assess whether the presence of the husband compromises the sterile environment required for safe anesthesia administration during cesarean sections.
Measure infection rates or instances of breaches in sterile technique
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perioperative period
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Patient Satisfaction
Tidsramme: immediately after the procedure
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we will Gauge the satisfaction levels of mothers who had their husbands present during cesarean section a validated Likert scale questionnaire immediately after the procedure Satisfaction Scale
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immediately after the procedure
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Neonatal Outcomes
Tidsramme: 1 and 5 minutes after neonatal delivery
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Recorded variables will include Apgar scores at 1 and 5 minutes, and the need for neonatal resuscitation.
The score is determined through the evaluation of the newborn in five criteria: appearance, pulse, grimace, activity (tone), and respiration.
For each criterion, newborns can receive a score from 0 to 2.
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1 and 5 minutes after neonatal delivery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bryanton J, Gagnon AJ, Johnston C, Hatem M. Predictors of women's perceptions of the childbirth experience. J Obstet Gynecol Neonatal Nurs. 2008 Jan-Feb;37(1):24-34. doi: 10.1111/j.1552-6909.2007.00203.x.
- Bohren MA, Hofmeyr GJ, Sakala C, Fukuzawa RK, Cuthbert A. Continuous support for women during childbirth. Cochrane Database Syst Rev. 2017 Jul 6;7(7):CD003766. doi: 10.1002/14651858.CD003766.pub6.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. juni 2026
Primær færdiggørelse (Anslået)
15. juni 2027
Studieafslutning (Anslået)
15. juni 2027
Datoer for studieregistrering
Først indsendt
10. maj 2026
Først indsendt, der opfyldte QC-kriterier
7. juni 2026
Først opslået (Faktiske)
11. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juni 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- Husband Attendance in CS
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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