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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).
Currently there is a paucity of literature to determine the efficacy of use of Pitocin during Foley placement, a single study has been published which suggests that the induction to delivery time is shortened in multiparas, but not in nulliparas. This study was not specifically powered to assess nulliparas as well, without increased risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | No oxytocin while the Foley bulb is in place | |
| Oxytocin | Experimental | Use of oxytocin while the Foley bulb is in place |
|
| PROMS Foley and oxytocin | Experimental | Subjects who are induced due to premature rupture of membranes randomized to use of Foley bulb and oxytocin once the bulb is removed. |
|
| PROMS no Foley bulb | No Intervention | Subjects who are induced due to premature rupture of membranes randomized to no Foley bulb. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | Use of oxytocin while the Foley bulb is in place |
|
| Measure | Description | Time Frame |
|---|---|---|
| induction time to delivery | 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. | Time from induction to delivery, average 12-28 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mode of delivery | 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. | average of 12-28 hours from induction until official time of birth |
| estimated blood loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Bianco, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elmhurst Hospital Center | Elmhurst | New York | 11373 | United States | ||
| Icahn School of Medicine at Mount Sinai |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28651258 | Derived | Connolly KA, Kohari KS, Factor SH, Rekawek P, Miller MR, Smilen BS, Stone JL, Bianco AT. A Randomized Trial of Foley Balloon Induction of Labor Trial in Multiparas (FIAT-M). Am J Perinatol. 2017 Sep;34(11):1108-1114. doi: 10.1055/s-0037-1603994. Epub 2017 Jun 26. No abstract available. |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| average of 12-28 hours from induction until official time of birth |
| uterine atony | uterine atony is assessed by both provider report and/or the use of uterotonics as indicated by the chart. | average of 12-28 hours from induction until official time of birth |
| chorioamnionitis | 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. | average of 12-28 hours from induction until official time of birth |
| neonatal birthweight | average of 12-28 hours from induction until official time of birth |
| New York |
| New York |
| 10029 |
| United States |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |