Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term

Study Overview
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Brief Summary
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To compare concurrent oxytocin with membrane sweeping versus dinoprostone pessary in labor induction for nulliparas at term with an unfavorable cervix

Official Title
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Concurrent Oxytocin With Membrane Sweeping Versus Dinoprostone Pessary in Labor Induction of Nulliparas at Term

Conditions
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Failed Induction of Labor

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Dinoprostone
* Procedure: Membrane sweeping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton pregnancy Nulliparous women gestational age >=37.0 weeks Bishop score <=6 intact amniotic membrane absence of labor live fetus with vertex presentation no previous uterine surgical procedure Exclusion Criteria: Multiple pregnancy Placenta previa
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin & Membrane sweeping<br>Women assigned to Concurrent oxytocin with membrane sweeping had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, followed by oxytocin infusion the next day | Drug: Oxytocin<br> <br> Procedure: Membrane sweeping<br> <br> |
| Active Comparator: Oxytocin & Dinoprostone<br>For women assigned to Concurrent oxytocin with dinoprostone vaginal insert: The 10mg dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening, followed by oxytocin infusion the next day | Drug: Oxytocin<br> <br> Drug: Dinoprostone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal delivery within 24 hours | Vaginal delivery within 24 hours is defined as vaginal delivery after 24 hours of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) on the first day of induction. | From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of vaginal delivery, assessed up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful labor induction | to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm | From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of active phase of labor ( defined as a cervical dilatation of >=4cm), assessed up to 24 hours | 
| Incidence of cesarean delivery | From the time of initiating intervention (i.e.concurrent membrane sweeping with dinoprostone or only dinoprostone) until the time of cesarean delivery, assessed up to 120 hours | End of labor induction (assessed up to 120 hours) | 
| The interval from start of oxytocin to delivery |  | From the time of initiating oxytocin infusion until the time of delivery, assessed up to 120 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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membrane sweeping, dinoprostone, nulliparas, labor induction