Concurrent Membrane Sweeping With Dinoprostone Versus Dinoprostone in Labor Induction of Nulliparas at Term With an Unfavorable Cervix

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

Conditions
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Nulliparous Women Who Scheduled for Labor Induction

Intervention / Treatment
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* Procedure: Concurrent membrane sweeping with Dinoprostone
* Drug: 10mg Dinoprostone vaginal insert


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: Concurrent membrane sweeping with Dinoprostone<br> | Procedure: Concurrent membrane sweeping with Dinoprostone<br>* Women assigned to Sweep had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, immediately followed by the placement of a 10mg Dinoprostone vaginal insert in the posterior fornix.<br>|
| Active Comparator: Dinoprostone<br> | Drug: 10mg Dinoprostone vaginal insert<br>* For women assigned to No sweep: The only 10mg Dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening<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. | Twenty-four hours of initiating intervention (i.e. membrane sweeping or PG) on the first day of induction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical change in the bishop scores and cervical lengths | Cervical change based on the bishop score and cervical length induced by two cervical ripening methods(concurrent membrane sweeping with dinoprostone vs. dinoprostone) Incidence of cesarean delivery Successful labor induction (defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm). The interval from start of oxytocin to delivery Incidence of rupture of membranes Incidences of vaginal bleeding and fever | Initiation of oxytocin after removing dinoprostone vaginal insert | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor induction, Cervical ripening, Dinoprostone, Membrane sweeping, Nulliparous women, Trial