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

9. november 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

64

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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.

-

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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."
Fremgangsmåte: 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.

Andre navn:
  • Extra-amniotic Saline Infusion
  • EASI with Foley Catheter
  • Combined Mechanical Induction
  • Transcervical Saline Infusion
Aktiv komparator: 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."
Fremgangsmåte: 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.

Andre navn:
  • Transcervical Foley Catheter
  • Intrauterine Foley Balloon
  • Mechanical Cervical Ripening
  • Single-balloon Foley Catheter

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Bishop Score (ΔBishop)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Rate of Vaginal Delivery within 24 Hours
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ankara City Hospital Bilkent

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. februar 2026

Primær fullføring (Antatt)

10. januar 2027

Studiet fullført (Antatt)

10. februar 2027

Datoer for studieregistrering

Først innsendt

9. november 2026

Først innsendt som oppfylte QC-kriteriene

9. november 2026

Først lagt ut (Faktiske)

13. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. november 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TABED 2-25-1766

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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