Labor InductionNCT03050684
Does Vaginal Washing Affect the Success Rate of the Labour Induction?
A study testing vaginal lavage group in people with Labor Induction and Dinoprostone Vaginal Insert, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Induction, Dinoprostone Vaginal Insert, Vaginal Infection
- What is being tested?
- vaginal lavage group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2017to 20 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Participiants with fetal demise
- Participiants with emercency delivery indications,
- Participiants with previous cesarean delivery or have other uterine surgery
- Participiants with cephalopelvic disproportion
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Maternity and Children Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Being tested
- vaginal lavage group, Control Group
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal lavage groupProcedure or surgery
vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
Control GroupProcedure or surgery
vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: vaginal lavage group |
| Control group | Placebo comparator | We will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Succesful cervical repining which allows succesful vaginal delivery
Cervical ripening is defined cervical Bishop score >5 the indication of unsuccessful induction
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start20 Feb 2017
- Primary completion10 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Yayla Abide, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- İlter Yenidede, MD, Principal investigator, Zeynep Kamil Maternity and Children HospitalÇetin Kılıççı, Principal investigator, Zeynep Kamil Maternity and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050684
- Sponsor's protocol ID
- 2016-162
- Status last verified
- Jan 2018
- First submitted
- 21 Jan 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Vaginal Washing Before Inserting Dinoprostone Affect the Success Rate of the Labour Induction?
- ClinicalTrials.gov ID
- NCT03050684
- Acronym / sponsor ID
- 2016-162
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 13 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| vaginal lavage group | Active comparator | Procedure: vaginal lavage groupWe 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 GroupWe will insert dinoprostone (Propess ®) vaginal ovule without vaginal lavage. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with singleton pregnancies
- Term gestational week (defined as>37 weeks),
- Fetal cephalic presentation
- Participiants with with intact amniotic membrane
- Reactive fetal heart rate
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginal lavage groupvaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion. | Procedure or surgery | vaginal lavage group |
| Control Groupvaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion. | Procedure or surgery | Control group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İlter Yenidede, MD principal investigator
Zeynep Kamil Maternity and Children Hospital
Çetin Kılıççı principal investigator
Zeynep Kamil Maternity and Children Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginal lavage group in people with Labor Induction and Dinoprostone Vaginal Insert, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Succesful cervical repining which allows succesful vaginal delivery (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.