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

9 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

64

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

-

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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."
Procedure: 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.

Andere namen:
  • Extra-amniotic Saline Infusion
  • EASI with Foley Catheter
  • Combined Mechanical Induction
  • Transcervical Saline Infusion
Actieve vergelijker: 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."
Procedure: 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.

Andere namen:
  • Transcervical Foley Catheter
  • Intrauterine Foley Balloon
  • Mechanical Cervical Ripening
  • Single-balloon Foley Catheter

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Bishop Score (ΔBishop)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of Vaginal Delivery within 24 Hours
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ankara City Hospital Bilkent

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2026

Primaire voltooiing (Geschat)

10 januari 2027

Studie voltooiing (Geschat)

10 februari 2027

Studieregistratiedata

Eerst ingediend

9 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

9 november 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TABED 2-25-1766

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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