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Foley Catheter vs. Foley + Extra-amniotic Saline Infusion for Labor Induction at 41 Weeks and Beyond (FEASI)

9 novembre 2026 mis à jour par: Ayşenur Türe, Ankara City Hospital Bilkent

The Effect of Foley Catheter Versus Foley Plus Extra-amniotic Saline Infusion on Bishop Progression, Labor Parameters, and Perinatal Outcomes in Pregnancies at 41 Weeks and Beyond: A Randomized Controlled Trial"

This study is a prospective, randomized controlled trial conducted at Ankara Bilkent City Hospital to compare two mechanical methods for labor induction in post-term pregnancies. The research evaluates the efficacy and safety of a Foley catheter alone versus a Foley catheter combined with extra-amniotic saline infusion (EASI). The study specifically targets primiparous women with a gestational age greater than or equal to 41+0 weeks and an unfavorable cervix, defined as an initial Bishop score less than or equal to 6. The primary objective is to determine the change in the Bishop score within the first 6 hours to identify which method more effectively promotes cervical ripening and successful labor induction.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Background and Rationale: Labor induction is the artificial initiation of contractions before spontaneous labor to achieve vaginal delivery. Mechanical methods, such as the Foley catheter, induce cervical ripening by creating physical pressure and stimulating the local release of prostaglandins. This study aims to provide evidence-based data on whether the addition of a continuous saline infusion (EASI) to the Foley catheter results in shorter labor durations and higher vaginal delivery rates compared to the catheter alone.

Study Design and Population:

  • Design: A prospective, 1:1 randomized controlled clinical trial.
  • Setting: All procedures are conducted under standardized aseptic conditions by trained operators in the delivery unit of Ankara Bilkent City Hospital.
  • Sample Size: Based on a power analysis with an effect size of $d = 0.80$, a total of 60 to 64 participants (30 to 32 per group) will be enrolled to account for potential data loss.

Inclusion and Exclusion Criteria:

  • Inclusion: Primiparous women , gestational age greater than or equal to 41+0 weeks , singleton pregnancy in cephalic presentation , reactive non-stress test (NST) with a biophysical profile greater than or equal to 8/10 , and a Bishop score less than or equal to 6.
  • Exclusion: Multiple pregnancies , ruptured membranes , previous uterine surgery (e.g., Cesarean section) , placenta previa , fetal growth restriction (IUGR) , or high-risk systemic diseases such as severe heart disease or diabetes.

Study Procedures and Monitoring: Participants are randomly assigned to either the Foley group or the Foley+EASI group. Labor progress is monitored according to standard obstetric protocols. The study monitors several parameters, including the time from induction to active labor, total delivery time, and the mode of delivery.

Outcome Measures:

  • Primary Outcome: Change in the Bishop score recorded 6 hours after induction.
  • Secondary Outcomes: Vaginal delivery rate within 24 hours , Cesarean section rates and indications , maternal infection indicators such as fever greater than or equal to 38°C or chorioamnionitis , and neonatal outcomes including Apgar scores and birth weight.

Statistical Analysis: Data will be analyzed using descriptive statistics. Continuous variables will be compared using the Student's t-test or Mann-Whitney U test , while categorical variables will be evaluated using the Chi-square or Fisher's exact test. A p-value less than 0.05 will be considered statistically significant.

Type d'étude

Interventionnel

Inscription (Estimé)

64

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

Primiparous women (First-time mothers).

Gestational age greater than or equal to 41+0 weeks.

Singleton pregnancy in cephalic presentation.

Unfavorable cervix, defined as a Bishop score less than or equal to 6.

Reactive Non-Stress Test (NST) and a biophysical profile score greater than or equal to 8/10.

Aged greater than or equal to 18 years.

Willingness to provide written informed consent. -

Exclusion Criteria:

Multiple pregnancies (e.g., twins, triplets).

Previous uterine surgery (e.g., prior Cesarean section or myomectomy).

Premature Rupture of Membranes (PROM).

Presence of placenta previa or vasa previa.

Fetal growth restriction (IUGR).

Active genital herpes infection.

Known hypersensitivity to the materials used (e.g., latex allergy if applicable).

Serious maternal systemic diseases (e.g., severe heart disease, uncontrolled diabetes, or preeclampsia).

Fetal anomalies or non-reassuring fetal heart rate patterns.

-

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Foley Catheter + EASI

"Participants in this arm will receive a single-balloon Foley catheter (16-18 French) inserted into the extra-amniotic space through the internal os of the cervix. The balloon will be inflated with 30-50 ml of sterile saline. Additionally, a continuous extra-amniotic saline infusion (EASI) will be administered at a rate of 30 ml/hour to enhance cervical ripening."
Procédure: Foley Catheter with Extra-amniotic Saline Infusion (EASI)

A single-balloon Foley catheter (16-18 French) is inserted through the internal os of the cervix into the extra-amniotic space under aseptic conditions. The balloon is inflated with 30-50 ml of sterile saline. Following placement, a continuous extra-amniotic saline infusion (EASI) is administered through the catheter at a constant rate of 30 ml per hour using an infusion pump. The procedure aims to induce cervical ripening through both mechanical pressure and biochemical stimulation.

Autres noms:
  • Extra-amniotic Saline Infusion
  • EASI with Foley Catheter
  • Combined Mechanical Induction
  • Transcervical Saline Infusion
Comparateur actif: Foley Catheter Alone

Participants in this arm will receive a single-balloon Foley catheter (16-18 French) inserted into the extra-amniotic space through the internal os of the cervix. The balloon will be inflated with 30-50 ml of sterile saline. No additional saline infusion will be administered. This group serves as the standard mechanical induction control."
Procédure: Foley Catheter Alone

A single-balloon Foley catheter (16-18 French) is inserted through the internal os of the cervix into the extra-amniotic space under aseptic conditions. The balloon is inflated with 30-50 ml of sterile saline. The catheter is then taped to the inner thigh of the patient to maintain tension. No saline infusion is administered in this group. The catheter remains in place until spontaneous expulsion or for a maximum duration of 12 hours.

Autres noms:
  • Transcervical Foley Catheter
  • Intrauterine Foley Balloon
  • Mechanical Cervical Ripening
  • Single-balloon Foley Catheter

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Bishop Score (ΔBishop)
Délai: From baseline (0 hour) to 6 hours after catheter insertion

The Bishop score is a pre-labor scoring system to assist in predicting whether induction of labor will be required. The score (ranging from 0 to 13) evaluates cervical dilation, effacement, consistency, position, and fetal station. This measure represents the numerical increase in the score after 6 hours of induction.
From baseline (0 hour) to 6 hours after catheter insertion

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Rate of Vaginal Delivery within 24 Hours
Délai: Within 24 hours of induction initiation

The percentage of participants who achieved a successful vaginal delivery within the first 24 hours
Within 24 hours of induction initiation
Total Induction to Delivery Duration
Délai: From the start of catheter insertion until the birth of the neonate (typically up to 48 hours).

The total time elapsed (in hours) from the beginning of the induction procedure to the actual delivery
From the start of catheter insertion until the birth of the neonate (typically up to 48 hours).
Neonatal Apgar Scores
Délai: At 1 minute and 5 minutes after birth.

Evaluation of the newborn's physical condition using the Apgar scoring system (0-10 scale).
At 1 minute and 5 minutes after birth.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ankara City Hospital Bilkent

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 février 2026

Achèvement primaire (Estimé)

10 janvier 2027

Achèvement de l'étude (Estimé)

10 février 2027

Dates d'inscription aux études

Première soumission

9 novembre 2026

Première soumission répondant aux critères de contrôle qualité

9 novembre 2026

Première publication (Réel)

13 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 novembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TABED 2-25-1766

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

There is no plan to share individual participant data. The study results will be published in aggregate form in a peer-reviewed journal

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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