Foley Labor Induction Trial at Term and in PROM
A Randomized Trial of Foley Bulb Induction With and Without Simultaneous Use of Oxytocin
This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.
Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed.
After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).
Studie Overzicht
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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New York
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Elmhurst, New York, Verenigde Staten, 11373
- Elmhurst Hospital Center
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New York, New York, Verenigde Staten, 10029
- Icahn School of Medicine at Mount Sinai
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- women at > 24 weeks gestation
- a non-anomalous, singleton fetus in a vertex presentation
Exclusion Criteria:
- history of prior uterine surgery such as cesarean section or myomectomy
- unexplained vaginal bleeding
- latex allergy
- contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)
Studie plan
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 |
|---|---|
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Geen tussenkomst: Control
No oxytocin while the Foley bulb is in place
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Experimenteel: Oxytocin
Use of oxytocin while the Foley bulb is in place
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Use of oxytocin while the Foley bulb is in place
Andere namen:
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Experimenteel: PROMS Foley and oxytocin
Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed.
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Use of oxytocin while the Foley bulb is in place
Andere namen:
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Geen tussenkomst: PROMS no Foley bulb
Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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induction time to delivery
Tijdsspanne: Time from induction to delivery, average 12-28 hours
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The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate.
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Time from induction to delivery, average 12-28 hours
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Mode of delivery
Tijdsspanne: average of 12-28 hours from induction until official time of birth
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The mode of delivery is ascertained from the delivery summary as either spontaneous vaginal delivery, cesarean delivery, vacuum assisted vaginal delivery, or forcep assisted vaginal delivery.
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average of 12-28 hours from induction until official time of birth
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estimated blood loss
Tijdsspanne: average of 12-28 hours from induction until official time of birth
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average of 12-28 hours from induction until official time of birth
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uterine atony
Tijdsspanne: average of 12-28 hours from induction until official time of birth
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uterine atony is assessed by both provider report and/or the use of uterotonics as indicated by the chart.
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average of 12-28 hours from induction until official time of birth
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chorioamnionitis
Tijdsspanne: average of 12-28 hours from induction until official time of birth
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Chorioamnionitis is ascertained from provider report as fever with either maternal/fetal tachycardia, fundal tenderness, or foul smelling fluid while the patient is in labor.
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average of 12-28 hours from induction until official time of birth
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neonatal birthweight
Tijdsspanne: average of 12-28 hours from induction until official time of birth
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average of 12-28 hours from induction until official time of birth
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Angela Bianco, MD, Icahn School of Medicine at Mount Sinai
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- GCO 13-1279
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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