As of February 13 2026 a university led trial assesses whether partner presence in the cesarean operating room changes recovery quality for the birthing patient. The study compares standard care with partner presence in the operating room during cesarean delivery and is not yet recruiting. Sponsored by Karamanoğlu Mehmetbey University the trial is registered on ClinicalTrials.gov under NCT07406607. This article explains what changed in the research question how the trial is designed and what regulators and clinicians should watch for as the work progresses. In this article you will find a concise update on scope design potential clinical implications and next steps for care teams and policy makers. In this article navigation will help you jump to the sections that cover what changed how the study is built what the findings could mean for patient safety and for hospital policy.
What changed in the research question?
The key shift in this inquiry is to examine the role of a partner or companion during the caesarean section and its potential impact on the mother moment after delivery and recovery trajectory. The trial defines two arms standard care with no partner present in the operating room and partner presence in the operating room during surgery. The setting is obstetric and procedural focusing on recovery quality as the primary consideration. The sponsor is Karamanoglu Mehmetbey University and the study is listed on ClinicalTrials.gov as NCT07406607. Status is not yet recruiting which means results are pending and regulatory agencies will observe recruitment progress and safety reporting as the study moves forward.
Why this matters for patients and care teams
Understanding whether partner presence influences recovery could affect patient experience while maintaining safety and privacy. Regulators may consider policies that govern patient support in the operating room as part of service provision rather than device deployment. The description clearly separates this intervention from a medical device and frames it within health care service design and human factors for patient centered care.
How is the trial designed and what evidence base informs it?
The intervention compares two approaches in cesarean delivery under standard obstetric care. One arm uses standard care with no partner in the operating room; the other adds partner presence with the consent and comfort of the patient. The study is not yet recruiting, consistent with early stage assessment and ethics review. The information provided in the registry highlights the setting maternal recovery as the target outcome and indicates the sponsor and registry details. In regulatory terms the trial documents the intended population the procedural context and the comparator approach to ensure traceability and safety oversight.
Interventions
Standard care with no partner present versus partner presence in the operating room as described in the trial protocol. The description does not indicate device related actions and positions the intervention as a care process rather than a device feature.
What are the regulatory implications for care settings and devices?
Because the study frames partner presence as a care process rather than a device function the regulatory focus centers on patient safety privacy and staff conduct in the operating room. The registry notes the intended use is observational of recovery quality in the context of cesarean delivery under standard care. There is no claim of a medical device in the description and no claims about device performance. If results suggest a beneficial effect authorities may consider recommendations for hospital policy review and risk management in obstetric services consistent with MDR style language.
What safety considerations exist for study participants?
Key considerations include ensuring patient consent privacy and comfort in the operating room environment. As the trial is not recruiting results and safety monitoring plans are expected to be described in the registry the emphasis is on governance alignment with hospital policies and ethics board approvals. The design aims to minimize disruption to standard care while capturing recovery outcomes in a controlled manner.
FAQ
- 1. What is the intervention?
The intervention is partner presence in the operating room during cesarean delivery compared with standard care with no partner present.
- 2. What is the trial status?
The trial is not yet recruiting.
- 3. Who sponsors the trial?
Sponsored by Karamanoğlu Mehmetbey University.
- 4. Where is the trial registered?
ClinicalTrials.gov listing NCT07406607.
Conclusion and implications for practice
This study explores a non device centered approach to improving maternal recovery by evaluating partner presence during cesarean delivery. If the results show a positive effect while maintaining safety privacy and patient autonomy hospital leaders regulators and clinicians may consider policy updates to support patient centered care during surgical care. The work remains at the early stage and results will guide future investigations and potential service level modifications.
Disclaimer This information is intended for health care professionals and researchers. It is not legal or medical advice. Consult regulatory guidance and institutional policies as appropriate.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07406607?term=medical+device