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Enrolling by Invitation

NCT Number: NCT07641751

Effect of Husband Attendance on Anesthesia Performance and Maternal-Neonatal Outcomes During Elective Cesarean Section Under Spinal Anesthesia

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.

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Key information

Conditions

Husband Attendance Maternal-Neonatal Outcomes

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

medical research institute , Alexandrria university

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Husbands will be allowed to attend the cesarean section procedure, providing emotional support to their partners.

Behavioral

Husbands will be allowed to attend the cesarean section procedure, providing emotional support to their partners.

Husbands will not be permitted to attend the cesarean section procedure

Behavioral

Husbands will not be permitted to attend the cesarean section procedure

Primary outcomes

  1. Anesthesia Administration

    Time frame: intraoperative period

    we will assess the efficiency and accuracy of anesthesia administration during cesarean sections with husband attendance. Measure factors such as induction time in minutes.

  2. Surgical Delays

    Time frame: intraoperative period

    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.

  3. Complications

    Time frame: intraoperative period

    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.

  4. Sterility and Infection Control

    Time frame: perioperative period

    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

Secondary outcomes

  1. Patient Satisfaction

    Time frame: immediately after the procedure

    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

    • = Very Dissatisfied
    • = Dissatisfied
    • = Neutral
    • = Satisfied
    • = Very Satisfied

  2. Neonatal Outcomes

    Time frame: 1 and 5 minutes after neonatal delivery

    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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effect of Husband Attendance on Anesthesia Performance and Maternal-Neonatal Outcomes During Elective Cesarean Section Under Spinal Anesthesia: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.