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Impact of Standardization on Outcomes Following Cervical Ripening

4 maj 2026 uppdaterad av: Sarah Morgan Carpenter, Indiana University
The primary purpose of this study is to determine if vaginal delivery rate is impacted by the use of standardized methods of cervical ripening. Additional outcomes will be evaluated including maternal and fetal outcomes of labor.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

The goal of this study is to evaluate the impact of standardization of cervical ripening on labor outcomes as well as to evaluate whether different methods of cervical ripening influence labor outcomes The primary outcome will be SVD rate. Secondary outcomes will include time from admission to delivery, total duration of hospitalization (admission to discharge), operative vaginal delivery rate, incidence of delivery within 24 hours of admission, maximal dose of oxytocin (in mU/min), incidence of tachysystole requiring intervention, incidence of intervention for fetal bradycardia or "non-reassuring fetal status", maternal morbidity (endometritis, 3rd or 4th degree lacerations, hemorrhage >1000mL, blood transfusion, wound separation or infection or readmission), neonatal length of stay>3 days, NICU admission.

Studietyp

Interventionell

Inskrivning (Beräknad)

1158

Fas

  • Fas 2
  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202
        • Sidney & Lois Eskenazi Hospital
        • Kontakt:
          • Sarah M Carpenter, MD
          • Telefonnummer: 317-880-2229
          • E-post: semorgan@iu.edu

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

Inclusion Criteria:

  • Patients who are scheduled for medically indicated or elective induction of labor with gestational age ≥37 weeks at Eskenazi hospital
  • Willing and able to provide informed consent
  • Age ≥18 years old
  • Able to read, speak and understand English, Spanish or Haitian Creole

Exclusion Criteria:

  • Premature rupture of membranes
  • Known chorioamnionitis
  • Fetal malpresentation
  • Placenta previa
  • Category 3 fetal heart rate tracing -- only at the time of screening and enrollment. If a Category III tracing develops later in labor, this will prompt standard obstetric management, not removal from the study.
  • Prior uterine scar (cesarean delivery or other contraindication to use of prostaglandins)
  • Major fetal anomalies known at the time of enrollment that are expected to meaningfully impact labor management
  • Multiple gestation
  • Allergy to misoprostol or other contraindication to induction of labor or use of misoprostol or cook cervical ripening balloon
  • Patient does not require cervical ripening (SBS ≥ 6 or dilation ≥ 4cm)
  • Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Cervical Ripening with a double balloon catheter only
Enhet: Cervical Ripening with a double balloon catheter only
Labor induction will include cervical ripening with the use of a double balloon catheter without medication at the same time. After the balloon comes out (is taken out or falls out), the rest of the labor course will be managed by your provider
Experimentell: Cervical ripening with a double balloon catheter plus misoprostol
Kombinationsprodukt: Cervical ripening with a double balloon catheter plus misoprostol
The labor induction will include cervical ripening with the use of a double balloon catheter and the medication misoprostol at the same time. After the balloon comes out (is taken out or falls out), the rest of your labor course will be managed by the provider.
Aktiv komparator: Usual-care control group
Cervical ripening will occur using the method chosen by your provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor.
Kombinationsprodukt: Usual-care control group
Cervical ripening will occur using the method chosen by the provider as part of standard clinical care. This may include the use of a double balloon catheter, misoprostol, both, or other methods commonly used for induction of labor.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
SVD rate
Tidsram: From enrollment until delivery, up to four days
The primary outcome measure for this study is Spontaneous Vaginal Delivery (SVD) rate which is measured as the proportion of patients who deliver vaginally.
From enrollment until delivery, up to four days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
SVD rate for study arm 1 versus study arm 2 (% difference)
Tidsram: From enrollment until delivery, up to four days
Comparing (Spontaneous Vaginal Delivery) SVD rates between Cervical Ripening with a double balloon catheter only arm and Cervical ripening with a double balloon catheter plus misoprostol arm.
From enrollment until delivery, up to four days
Incidence of delivery within 24 hours of admission
Tidsram: Enrollment until delivery, up to four days
Enrollment until delivery, up to four days
Incidence of tachysystole requiring intervention
Tidsram: Enrollment until study completion, up to 94 days
Enrollment until study completion, up to 94 days
Incidence of intervention for fetal bradycardia or "non reassuring fetal status"
Tidsram: Enrollment until study completion, up to 94 days
Enrollment until study completion, up to 94 days
Rate of Maternal endometritis
Tidsram: Enrollment until study completion, up to 94 days
Enrollment until study completion, up to 94 days
Composite maternal morbidity
Tidsram: From delivery until 30 days after delivery
measured by % endometritis, 3rd or 4th degree lacerations, QBL >1000mL, intrapartum or postpartum blood transfusion, wound separation or infection, hospital readmission within 30 days after delivery
From delivery until 30 days after delivery
neonatal length of stay >3 days
Tidsram: From delivery until 3 days post delivery
From delivery until 3 days post delivery
Rate of NICU admission
Tidsram: From delivery until study completion, up to 94 days
From delivery until study completion, up to 94 days
Quantitative Blood Loss
Tidsram: From delivery until discharge, up to 4 days
blood loss measured in mL
From delivery until discharge, up to 4 days
Time from admission to delivery
Tidsram: From admission until delivery, up to four days
From admission until delivery, up to four days
Total duration of hospitalization
Tidsram: From admission to discharge, up to 8 days
Total duration of hospitalization measured from admission to discharge
From admission to discharge, up to 8 days

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Indiana University

Samarbetspartners

Indiana University Health

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 december 2027

Avslutad studie (Beräknad)

1 april 2028

Studieregistreringsdatum

Först inskickad

26 februari 2026

Först inskickad som uppfyllde QC-kriterierna

4 maj 2026

Första postat (Faktisk)

8 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 27548

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

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