Does Vaginal Washing Before Inserting Dinoprostone Affect the Success Rate of the Labour Induction?
| Registry | NCT03050684 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, screening |
| Enrollment | 200 (Actual) |
| Sponsor | Zeynep Kamil Maternity and Pediatric Research and Training Hospital (Other) |
| Conditions | Labor Induction, Dinoprostone Vaginal Insert, Vaginal Infection, Effect Increased |
| Interventions | vaginal lavage group, Control Group (Procedure) |
| Dates | start 2017-02-20, primary completion 2017-12-10, completion 2017-12-20, first posted 2017-02-13, last updated 2018-01-31 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Labor Induction All trials for Dinoprostone Vaginal Insert All trials of vaginal lavage group All trials of Control Group
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| vaginal lavage group | Active comparator | Procedure: vaginal lavage group | We will make vaginal lavage with steril %0.9 NaCl serum ( 20cc) before inserting dinoprostone (Propess ®) 10 mg vaginal ovule |
| Control group | Placebo comparator | Procedure: Control Group | We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage. |
Sex: Female, ages: 18 Years to 40 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Zeynep Kamil Maternity and Children Hospital | Istanbul | Turkey (Türkiye) |