Does Vaginal Washing Affect the Success Rate of the Labour Induction?
Does Vaginal Washing Before Inserting Dinoprostone Affect the Success Rate of the Labour Induction?
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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Istanbul, Kalkon
- Zeynep Kamil Maternity and Children Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients with singleton pregnancies
- Term gestational week (defined as>37 weeks),
- Fetal cephalic presentation
- Participiants with with intact amniotic membrane
- Reactive fetal heart rate
- Cervical Modified Bishop's score <5
Exclusion Criteria:
- Patients with with multipl pregnancies
- Participiants with malpresentation anomalies
- Participiants with nonreassurring fetal heart rate
- Participiants with more than three contractions in 10 minutes
- Participiants with contrandications for using prostaglandins
- Participiants with fetal anomaly
- Participiants with fetal demise
- Participiants with emercency delivery indications,
- Participiants with previous cesarean delivery or have other uterine surgery
- Participiants with cephalopelvic disproportion
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: vaginal lavage group
We will make vaginal lavage with steril %0.9 NaCl serum ( 20cc) before inserting dinoprostone (Propess ®) 10 mg vaginal ovule
|
vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
|
|
Placebo-jämförare: Control group
We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage.
|
vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Succesful cervical repining which allows succesful vaginal delivery
Tidsram: 12 Months
|
Cervical ripening is defined cervical Bishop score >5 the indication of unsuccessful induction
|
12 Months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: İlter Yenidede, MD, Zeynep Kamil Maternity and Children Hospital
- Huvudutredare: Çetin Kılıççı, Zeynep Kamil Maternity and Children Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2016-162
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .