Does Vaginal Washing Affect the Success Rate of the Labour Induction?
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03050684|
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : January 31, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Labor Induction Dinoprostone Vaginal Insert Vaginal Infection Effect Increased||Procedure: vaginal lavage group Procedure: Control Group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Study|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Does Vaginal Washing Before Inserting Dinoprostone Affect the Success Rate of the Labour Induction?|
|Actual Study Start Date :||February 20, 2017|
|Actual Primary Completion Date :||December 10, 2017|
|Actual Study Completion Date :||December 20, 2017|
Active Comparator: vaginal lavage group
We will make vaginal lavage with steril %0.9 NaCl serum ( 20cc) before inserting dinoprostone (Propess ®) 10 mg vaginal ovule
Procedure: vaginal lavage group
vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
Placebo Comparator: Control group
We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage.
Procedure: Control Group
vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
- Succesful cervical repining which allows succesful vaginal delivery [ Time Frame: 12 Months ]Cervical ripening is defined cervical Bishop score >5 the indication of unsuccessful induction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050684
|Zeynep Kamil Maternity and Children Hospital|
|Principal Investigator:||İlter Yenidede, MD||Zeynep Kamil Maternity and Children Hospital|
|Principal Investigator:||Çetin Kılıççı||Zeynep Kamil Maternity and Children Hospital|