Labor, InducedNCT05100264
Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone for Labor Induction
A study testing Vaginal washing with 5% acetic acid and Vaginal washing with 0.9% NS in people with Labor, Induced and Induced; Birth, run by Alexandra Hospital, Athens, Greece at 1 site in Greece.
Trial summary
Acidification of vaginal pH has been proposed as a potential factor that could help increase the efficacy of vaginal prostaglandins in labor induction. The aim of the present randomized controlled trial is to evaluate the impact of an acidic vaginal pH on the progress of labor induction with dinoprostone… 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, Induced, Induced; Birth
- What is being tested?
- Vaginal washing with 5% acetic acid and Vaginal washing with 0.9% NS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteGreece
- Study dates
- 29 Oct 2021to 30 Dec 2022
- 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
- Singleton pregnancy
- Full term (>37 weeks)
- Cephalic presentation
- Reactive NST (nonstress test)
- Absence of spontaneous uterine contractions
- No contraindications to vaginal delivery
Who cannot join
- Multifetal pregnancy
- Fetal malpresentation
- Preterm delivery (<37 weeks)
- Advanced maternal age (>40 years)
- Bishop score > 7
- Fetal macrosomia ( >4500 gr)
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- Non reassuring NST (nonstress test)
- Suspected chorioamnionitis
- Previous cesarean delivery or other uterine surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone (PGE2) Vaginal Tablet for Labor Induction in Full Term Pregnant Women: A Randomized Controlled Trial
Acidification of vaginal pH has been proposed as a potential factor that could help increase the efficacy of vaginal prostaglandins in labor induction. The aim of the present randomized controlled trial is to evaluate the impact of an acidic vaginal pH on the progress of labor induction with dinoprostone (Prostaglandin E2 - PGE2) vaginal tablet.
- Conditions
- Labor, Induced, Induced; Birth
- Being tested
- Vaginal washing with 5% acetic acid, Vaginal washing with 0.9% NS
- Keywords
- labor induction, dinoprostone, vaginal pH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal washing with 5% acetic acidOther
Induction of labor (vaginal tablet dinoprostone and vaginal washing with 5% acetic acid)
Vaginal washing with 0.9% NSOther
Induction of labor (vaginal tablet dinoprostone and vaginal washing 0.9% NS)
| Study group | Role | What they receive |
|---|---|---|
| Vaginal washing 5% acetic acid | Experimental | Not described Receives: Other: Vaginal washing with 5% acetic acid |
| Vaginal washing 0.9% N/S | Placebo comparator | Not described Receives: Other: Vaginal washing with 0.9% NS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interval from induction to delivery
Time interval (minutes)
Measured: 36 hours
Secondary outcomes (3)
Interval from induction to active labor
Time interval (minutes)
Measured: 36 hours
Interval from induction to second stage of labor
Time interval (minutes)
Measured: 36 hours
Failure of induction of labor
Rate of participants with failure of induction of labor
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start29 Oct 2021
- Primary completion29 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor, InducedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandra Hospital, Athens, Greece
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Georgios Daskalakis, Alexandra Hospital, Athens, Greece
- Investigators
- Georgios Daskalakis, Study director, Alexandra General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100264
- Sponsor's protocol ID
- 68/7/22-9-21
- Status last verified
- Feb 2024
- First submitted
- 18 Oct 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acidic Vaginal pH on the Efficacy of Dinoprostone (PGE2) Vaginal Tablet for Labor Induction in Full Term Pregnant Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05100264
- Acronym / sponsor ID
- 68/7/22-9-21
- Conditions
- Labor, Induced, Induced; Birth
- Keywords
- labor induction, dinoprostone, vaginal pH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Alexandra Hospital, Athens, GreeceUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 29 Oct 2021 (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.
Acidification of vaginal pH has been proposed as a potential factor that could help increase the efficacy of vaginal prostaglandins in labor induction. The aim of the present randomized controlled trial is to evaluate the impact of an acidic vaginal pH on the progress of labor induction with dinoprostone (Prostaglandin E2 - PGE2) vaginal tablet.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal washing 5% acetic acid | Experimental | Other: Vaginal washing with 5% acetic acid |
| Vaginal washing 0.9% N/S | Placebo comparator | Other: Vaginal washing with 0.9% NS |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Singleton pregnancy
- Full term (>37 weeks)
- Cephalic presentation
- Reactive NST (nonstress test)
- Absence of spontaneous uterine contractions
Key exclusion criteria (9 listed)
- Multifetal pregnancy
- Fetal malpresentation
- Preterm delivery (<37 weeks)
- Advanced maternal age (>40 years)
- Bishop score > 7
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 washing with 5% acetic acidInduction of labor (vaginal tablet dinoprostone and vaginal washing with 5% acetic acid) | Other | Vaginal washing 5% acetic acid |
| Vaginal washing with 0.9% NSInduction of labor (vaginal tablet dinoprostone and vaginal washing 0.9% NS) | Other | Vaginal washing 0.9% N/S |
Primary outcome
Interval from induction to delivery
Time frame: 36 hours
Time interval (minutes)
3 secondary outcomes
Interval from induction to active labor
Time frame: 36 hours
Interval from induction to second stage of labor
Time frame: 36 hours
Failure of induction of labor
Time frame: 36 hours
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 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
Georgios Daskalakis study director
Alexandra General 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 washing with 5% acetic acid and Vaginal washing with 0.9% NS in people with Labor, Induced and Induced; Birth, run by Alexandra Hospital, Athens, Greece at 1 site in Greece.
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 9 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 20 Feb 2024. 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 Greece. 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?
Interval from induction to delivery (time frame: 36 hours). 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 20 Feb 2024.