IA Trial Radar | ||
|---|---|---|
El ensayo clínico NCT07491874 para Preterm Delivery, Cervical Cerclage, Insuficiencia cervical está aún no recluta. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
Un estudio coincide con los criterios de filtro
Vista de tarjeta
Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal- A Multicenter Randomized Controlled Study 60 Aleatorizado Embarazo
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT07491874 es un estudio intervencionista para Preterm Delivery, Cervical Cerclage, Insuficiencia cervical. Su estado actual es: aún no recluta. Se prevé iniciar el reclutamiento el 1 de mayo de 2026 hasta completar 60 participantes. Dirigido por Kaplan Medical Center, se espera que finalice el 1 de mayo de 2028. Los datos se actualizaron por última vez en ClinicalTrials.gov el 25 de marzo de 2026.
Resumen
The goal of this clinical trial is to determine whether inhaled nitrous oxide can reduce pain and anxiety during cervical cerclage removal compared with standard care. Cervical cerclage removal is commonly performed in the outpatient setting during the third trimester of pregnancy and may be associated with discomfort and anxiety despite being a brief procedure.
The study will include pregnant women aged 18 years or...
Mostrar másDescripción detallada
Cervical insufficiency is a recognized risk factor for spontaneous preterm birth, which remains a major cause of perinatal morbidity and mortality worldwide. Cervical cerclage is an established intervention used in carefully selected patients to reduce the risk of preterm birth.
While cerclage placement is typically performed under anesthesia in the operating room, cerclage removal is usually carried out in the outp...
Mostrar másTítulo oficial
Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal- A Multicenter Randomized Controlled Study
Condiciones médicas
Preterm DeliveryCervical CerclageInsuficiencia cervicalPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:- Teichman Y. and Mellik H. (1976). "State-Trait Anxiety Inventory," Tel-Aviv University, Ramot Press
- American College of Emergency Physicians. Managing Acute Pain in the ED - Nitrous Oxide. ACEP // Nitrous Oxide (viewed July 2021)
- Spielberger, C., Gorsuch, R., & Lushene, R. (1970). Manual for the State...
Otros ID del estudio
- 0034-26-KMC1-C
Número del NCT
Inicio del estudio (real)
2026-05-01
Última actualización
2026-03-25
Fecha de finalización (estimada)
2028-05-01
Inscripción (prevista)
60
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Aún no recluta
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalInhaled Nitrous Oxide During Cervical Cerclage Removal Participants in this arm will receive inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The equipment is identical to the device routinely used for labor analgesia in the participating institutions and will be operated and mo...Mostrar más | Inhaled nitrous oxide Inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The device is identical to the equipment routinely used for labor analgesia in the participating institutions and is operated and monitored by trained midwives experienced in ...Mostrar más |
Sin intervenciónStandard Care Without Analgesia Participants in this arm will undergo cervical cerclage removal without analgesia, in accordance with the standard practice across the participating institutions. The procedure will be performed in the outpatient setting following routine clinical protocols. Maternal vital signs and fetal status will be monitored according to standard clinical practice. No nitrous oxide or other analgesic intervention will be adminis...Mostrar más | N/A |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Pain intensity during cervical cerclage removal | Pain intensity will be assessed using a 0-100 mm visual analog scale (VAS). Participants will rate the level of pain experienced during the procedure 3-5 minutes after completion of the cerclage removal. | 3-5 minutes following completion of the procedure |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Difference between expected pain and experienced pain | Experienced pain will be assessed after the procedure using the same scale. The difference between expected and experienced pain scores will be analyzed. | Baseline (prior to procedure) and 3-5 minutes following completion of the procedure |
Procedure duration | Total duration of the cerclage removal procedure, measured in minutes from the beginning of the procedure to completion. | During procedure |
Change in maternal heart rate during procedure | Difference (delta) between baseline maternal heart rate and the maximal heart rate recorded during the procedure | Baseline measurement prior to the procedure and continuous monitoring during the procedure |
Change in anxiety level (STAI) | Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI). Participants will complete the questionnaire before the procedure and again after cerclage removal. The change in STAI score will be analyzed | Baseline (before procedure) and 3-5 minutes after completion of the procedure |
Patient satisfaction | Patient satisfaction with the procedure will be assessed using a Likert-scale questionnaire completed after cerclage removal | 3-5 minutes after completion of the procedure |
Adverse events | Occurrence of adverse events including nausea, dizziness, headache, or dyspnea reported during or immediately after the procedure | During procedure |
Conversion to neuraxial or general anesthesia | Need to convert from the assigned study condition (nitrous oxide or no analgesia) to epidural, spinal, or general anesthesia due to inability to complete the procedure | During the procedure |
Physician-rated procedural difficulty | The performing physician will provide a subjective assessment of the technical difficulty of cervical cerclage removal using a Likert scale | 3-5 minutes following completion of the procedure |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Mujer
- Age ≥18 years
- Women at ≥34 weeks of gestation
- Singleton or twin pregnancy
- Ability to understand, sign informed consent, and complete questionnaires
- Triplet or higher-order pregnancy
- Contraindications to nitrous oxide use
- Fetal monitoring category 2 or higher
- Maternal body temperature >38°C
- Significant vaginal bleeding
- Severe preeclampsia
- Cerclage removal under general anesthesia
- Language or cognitive barrier
- Baseline pain >3 on VAS scale, prior to the procedure
Kaplan Medical Center- ⚕️Clalit Hea...
Parte responsable del estudio
Gil Friedman, Investigador principal, Principal Investigator, OB-GYN Resident, Kaplan Medical Center
Contactos centrales del estudio
Contacto: Gil Friedman, +972584744356, [email protected]
4 Centros del estudio en 1 países
Central District
Kaplan Medical Center, Rehovot, Central District, 7639302, Israel
Gil Friedman, Contacto, +972584744356, [email protected]
Edith Wolfson Medical Center, Holon, Israel
Liat Mor, Contacto, +972546738294, [email protected]
Meir Medical Center, Kfar Saba, Israel
Sapir Nachshon, Contacto, +972526525154, [email protected]
Rabin Medical Center, Petah Tikva, Israel
Bar Narkis, Contacto, +972546335114