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).
Aperçu de l'étude
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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New York
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Elmhurst, New York, États-Unis, 11373
- Elmhurst Hospital Center
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New York, New York, États-Unis, 10029
- Icahn School of Medicine at Mount Sinai
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
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 |
|---|---|
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Aucune intervention: Control
No oxytocin while the Foley bulb is in place
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Expérimental: 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
Autres noms:
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Expérimental: 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
Autres noms:
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Aucune intervention: PROMS no Foley bulb
Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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induction time to delivery
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mode of delivery
Délai: 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
Délai: 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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|
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uterine atony
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Angela Bianco, MD, Icahn School of Medicine at Mount Sinai
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- GCO 13-1279
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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