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One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical. In cases of unfavorable cervix (Bishop score is below 5), cervical ripening can be induced by either prostaglandins E2 (slow release 10 mg dinoprostone insert (propess) or vaginal gel 1-2 mg) or mechanically by Foley catheter balloon (FCB).
The efficacy of labor induction of propess versus vaginal gel combined with FCB was not studied previously.
The goal of this randomized controlled trial is to compare the efficacy of propess versus PGE2 vaginal gel combined with FCB in women with singletons undergoing labor induction at term. The main question it aims to answer is to compare the time from the beginning of labor induction until delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Propess pessary | Experimental | Placement of a slow-release 10 mg dinoprostone insert (propess) in the posterior fornix for up to 24 hours until labor initiation or favorable cervix, followed by amniotomy and oxytocin administration. In a case of failure, induction of labor will be done with either PGE2 gel and/or Foley catheter. |
|
| Sequential PGE2 vaginal gel and Foley catheter balloon | Experimental | Insertion of 1 mg dinoprostone (PGE2) vaginal gel to the posterior fornix with reassessment up to 6 hours later. If the Bishop score is still less than 5 and there are no more than 4 contractions in 20 minutes of monitoring, an additional PGE2 vaginal gel of 2 mg is inserted. If there are more than 4 contractions in 20 minutes of monitoring or if after up to 6 hours there will be low Bishop score, a 60 ml Foley catheter balloon is placed for 6 to 12 hours or until spontaneous expulsion. When the cervix is favorable, amniotomy and oxytocin administration are followed. In a case of a failure, induction of labor with Propess will be conducted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinoprostone vaginal insert | Drug | Described in the arm descriptions |
|
| Measure | Description | Time Frame |
|---|---|---|
| comparing the duration of induction-to-vaginal delivery | measuring the duration of Induction-of-labor by Propess versus the combined use of PGE2 gel and balloon catheter by induction-to-vaginal delivery interval from the beginning of the induction according to the chosen patient protocol and until vaginal delivery. | from enrollment until final outcome - a month |
| Measure | Description | Time Frame |
|---|---|---|
| rate of vaginal delivery in 24 and 48 hours from IOL | the number of participants who had vaginal delivery in 24 and 48 hours from the beginning of the induction-of-labor for both protocols | from enrollment until final outcome - a month |
| Number of Participants with Treatment-Related Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zohar Nachum, Professor | Contact | +972547696562 | nachum.zo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zohar Nachum, Professor | Emek Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emek medical center | Recruiting | Afula | Israel |
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Parallel Assignment
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| Dinoprostone gel and Foley catheter balloon | Combination Product | Described in the arm descriptions |
|
Maternal -gathering the numbers of participants who had adverse events such as chorioamnionitis, endometritis, postpartum hemorrhage, uterine rupture, Neonatal -gathering the numbers of participants who had adverse events such as uterine hypertonia (contractions exceeding more than two minutes in duration) and/or tachysystole (more than 5 contractions in 10 minutes, averaged over a 30-minute period) with and without decelerations, non-reassuring fetal heart rate according to fetal monitoring, meconium-stained amniotic liquor, umbilical artery pH less than 7.1, Apgar score less than 7 at 5 min, postpartum transfer to neonatal intensive care unit, infection of the newborn |
| from enrollment until final outcome - a month |
| rate of Induction success | the number of participants who had ceasarean section | from enrollment until final outcome - a month |
| rate o Cervical ripening success | the duration from the beginning of the induction to bishop score 5 | from enrollment until final outcome - a month |