Dinoprostone Vaginal Insert, Effect Increased, Labor Induction, Vaginal Infection
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREvaginal lavage group
vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
PROCEDUREControl Group
vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
Sponsors
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized Controlled Study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Succesful cervical repining which allows succesful vaginal delivery | 12 Months | Cervical ripening is defined cervical Bishop score \>5 the indication of unsuccessful induction |
Countries
Turkey (Türkiye)
Outcome results
None listed