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Induction of labor is one of the most common obstetrical medical procedures performed today. Iatrogenic stimulation of uterine contractions prior to the onset of spontaneous labor is undertaken for various maternal and fetal indications and spans 20% of deliveries today.
In many circumstances of women with an unfavorable cervix (Bishop score of 7 or less) sequential induction with more than one agent is necessary. To date, no trial has compared the optimal subsequent ripening method after the preliminary use of dinoprostone (prostaglandin E2). In this trial investigators aim to compare the obstetrical outcomes of subsequent induction in women admitted for induction of labor with Bishop score <7 or less 24 hours after the insertion of vaginal prostaglandin insert (Propess). Two methods of routine induction of labor will be compared: An additional Propess induction for another 24 hours vs. intravenous oxytocin infusion combined with intra-cervical balloon insertion.
Induction of labor is one of the most common obstetrical medical procedures performed today. Iatrogenic stimulation of uterine contractions prior to the onset of spontaneous labor is undertaken for various maternal and fetal indications and spans 20% of deliveries today
In many circumstances of women with an unfavorable cervix (Bishop score of 7 or less) sequential induction with more than one agent is necessary. To date, no trial has compared the optimal subsequent ripening method after the preliminary use of dinoprostone (prostaglandin E2). In this trial investigators aim to compare the obstetrical outcomes of subsequent induction in women admitted for induction of labor with Bishop score <7 or less 24 hours after the insertion of vaginal prostaglandin insert (Propess). Two methods of routine induction of labor will be compared: An additional Propess induction for another 24 hours vs. intravenous oxytocin infusion combined with intra-cervical balloon insertion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Administration of Propess | Experimental | All women who failed induction of labor using vaginal insert slow release of dinoprostone 10 mg (Propess), defined as bishop score ≤ 7 24 hours after propess insertion will be randomized to one of the following treatment arms: 1.Administration of Propess for additional 24 hours. |
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| Intravenous oxytocin infusion + balloon | Experimental | All women who failed induction of labor using vaginal insert slow release of dinoprostone 10 mg (Propess), defined as bishop score ≤ 7 24 hours after propess insertion will be randomized to one of the following treatment arms: 2. Intravenous oxytocin infusion combined with intracervical balloon administration, inflated with 60cc of saline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Administration of Propess | Drug |
Follow up on all women will be performed from the time of second agent induction until discharge from hospital postpartum. |
| Measure | Description | Time Frame |
|---|---|---|
| Time from second agent induction to delivery | Time from second agent induction to active labor | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of failed induction defined as 5 cm dilatation | Defined as 5 cm dilatation with regular contractions | 48 hours |
| Rate of failed induction defined as regular contractions | Rate of failed induction defined as regular contractions (over 3 contractions in 30 min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yariv yogev, professor | Contact | 97236925603 | yarivy@tlvmc.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| yariv yogev, professor | Tel Aviv Medical Center | Principal Investigator |
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| balloon | Device |
Follow up on all women will be performed from the time of second agent induction until discharge from hospital postpartum. |
|
| Intravenous oxytocin infusion | Drug |
Follow up on all women will be performed from the time of second agent induction until discharge from hospital postpartum. |
|
| 48 hours |
| cesarean sections rate | Number of cesarean sections rate due to tachysystole and non-reassuring fetal heart rate. | 48 hours |