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Investigators will use dinoprostone(Propess TM) for cervix ripening and labor induction in term pregnant women.Vaginal pH base is achieved with the effect of hormones in pregnancy and associated with this, vaginal infections rates increase. With the vaginal application of Propess, the preparate remains in the vagina for a long time, with controlled release,creating a film layer against bacteria and especially fungal infections and it was thought that this could be a reason for unsuccessful birth induction by preventing release of this ovule.
The aim of this study is to observe whether or not the rate of caesareans with the indication of unsuccessful induction was reduced in patients by reducing the density of vaginal bacteria and fungi with vaginal lavage and thereby increasing the effect of the drug and decreasing the rate of unsuccessful inductions.
The study will include patients meeting the study criteria monitored in the delivery .
Verbal and written informed consent will be obtained from all patients before starting the study. The patients will be randomised to 2 groups. In one group, vaginal lavage (the vagina will first be washed with saline in a 20cc injector) will be applied then Propess will be used and in the other group Propess will be used without any lavage.
It is planned to include 70 patients in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaginal lavage group | Active Comparator | We will make vaginal lavage with steril %0.9 NaCl serum ( 20cc) before inserting dinoprostone (Propess ®) 10 mg vaginal ovule |
|
| Control group | Placebo Comparator | We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaginal lavage group | Procedure | vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Succesful cervical repining which allows succesful vaginal delivery | Cervical ripening is defined cervical Bishop score >5 the indication of unsuccessful induction | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ä°lter Yenidede, MD | Zeynep Kamil Maternity and Children Hospital | Principal Investigator |
| Çetin Kılıççı | Zeynep Kamil Maternity and Children Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeynep Kamil Maternity and Children Hospital | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D014627 | Vaginitis |
| ID | Term |
|---|---|
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Randomized Controlled Study
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| Control Group | Procedure | vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion. |
|
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D008722 | Methods |