Induction of Labor Clinical Trial
Official title:
Stepwise Labor Induction Following Failure of Prostaglandin Vaginal Insert for Labor Induction
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.
1. During the past years there has been an additional rise due to elective inductions
2. Induction is undertaken when potential risks of prolonging pregnancy outweigh the risks
of induced delivery, particularly those associated with post-term pregnancy, rupture of
membranes, oligohydramnios and additional fetal and maternal conditions that pose risks
to mother and fetus.
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
1. During the past years there has been an additional rise due to elective inductions
2. Induction is undertaken when potential risks of prolonging pregnancy outweigh the risks
of induced delivery, particularly those associated with post-term pregnancy, rupture of
membranes, oligohydramnios and additional fetal and maternal conditions that pose risks
to mother and fetus.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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|
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|
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|
||
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| Active, not recruiting |
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Phase 4 | |
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||
| Completed |
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||
| Completed |
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Phase 3 | |
| Completed |
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Phase 1 | |
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Phase 4 | |
| Completed |
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Phase 4 | |
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Phase 4 | |
| Completed |
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|
Phase 2 | |
| Recruiting |
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Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor
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| Recruiting |
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Phase 2 | |
| Completed |
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Phase 3 | |
| Terminated |
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N/A | |
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N/A |