Preterm BirthPROPEVNCT03689166
Effect of Probiotics on the Preterm Delivery Rate in Pregnant Women at High Risk for Preterm Birth
A study testing Probiotic in people with Preterm Birth, run by Maternal-Infantil Vall d´Hebron Hospital at 1 site in Spain.
Trial summary
Preterm birth (PB) continues to be the main cause of perinatal morbidity and mortality, with emotional and economic consequences. Despite improvements in health, PB prevalence remains stable, possibly due to complex causes such as maternal age, stress, multiparity, etc. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 23 Oct 2017to 16 Jun 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Threatened preterm labour: regular clinical and cardiotography-registered uterine dynamics, and cervical modifications (cervical shortening ≤ 25 mm between 24 and 29 weeks, and ≤ 15 mm between 30 and 34 weeks) according to our care protocol.
- Single gestation.
- Echographically-normal foetal morphology.
- Minimum age 18 years.
- Ability to understand informed consent.
- Signed informed consent.
Who cannot join
- Multiple gestations.
- Pregnant women with diagnosis of chorioamnionitis.
- Cervical dilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotics on the Preterm Delivery Rate (< 37 Weeks) in Pregnant Women at High Risk for Preterm Birth (Pregnant Women With Threatened Preterm Labour): PROPEV TRIAL Protocol
Preterm birth (PB) continues to be the main cause of perinatal morbidity and mortality, with emotional and economic consequences. Despite improvements in health, PB prevalence remains stable, possibly due to complex causes such as maternal age, stress, multiparity, etc. Shortening of the uterine cervix in early stages of gestation is a risk factor for PB. The presence of abnormal vaginal microbiota in the early stages of pregnancy is als a risk factor for PB. However, no studies have analysed the impact of probiotics (live microorganisms which, in adequate amounts, confer a health benefit on the host) on the PB in high-risk PB patients (pregnant women with threatened preterm delivery, i.e., uterine contractions and cervical shortening, with a 30% PB risk before 34 weeks, and 50% PB prior to 37 weeks (> 6-10% PB). Similarly, the effect of probiotics on vaginal flora dominated by lactic acid-producing bacteria could be analysed.
Read the detailed description
Hypothesis
- Pregnant women with threatened preterm labour (TPL) will present vaginal microbiome different from those without TPL.
- Treatment with probiotics will modify the vaginal microbioma of pregnant women with TPL.
- The PB rate before 37 weeks in pregnant women with TPL who have received probiotics since their diagnosis will be reduced by at least 30%.
Goals
- To correlate the use of probiotics of pregnant women with TPL with the PB rate before 37 weeks.
- To ascertain the PB rate before 28, 30, 32 and 34 weeks in both groups.
- To assess neonatal morbidity between both groups.
Methods
Prospective, randomised, longitudinal, prospective, double-blind study.
Relevance
This study will determine whether the use of probiotics in pregnant women with TPL is associated with a lower risk of PB before 37 weeks. If so, it would allow us to act on the tertiary prevention of PB and treatment of TPL, the main cause of perinatal morbidity and mortality in our setting. It will also facilitate understanding of the pathophysiology of PB, influence of vaginal microbiota and the mechanism of action of probiotics.
- Conditions
- Preterm Birth
- Being tested
- Probiotic, Placebo
- Keywords
- Probiotics, Preterm birth, Threatened preterm labour
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Reduce preterm birth with this dietary supplement
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Active comparator | Probiotic drug Receives: Dietary Supplement: Probiotic |
| Control group | Placebo comparator | This group will receive placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm birth rate <37 weeks
To evaluate the percentage of preterm birth in each group (in days of gestation)
Measured: From 24 to 37 weeks
Secondary outcomes (5)
Preterm birth rate <34 weeks
To evaluate the percentage of preterm birth in each group (in days of gestation)
Measured: From 24 to 34 weeks
Preterm birth rate <32 weeks
To evaluate the percentage of preterm birth in each group (in days of gestation)
Measured: From 24 to 32 weeks
Preterm birth rate <30 weeks
To evaluate the percentage of preterm birth in each group (in days of gestation)
Measured: From 24 to 30 weeks
Preterm birth rate <28 weeks
To evaluate the percentage of preterm birth in each group (in days of gestation)
Measured: From 24 to 38 weeks
Intergroup neonatal morbidity
To assess neonatal morbidity
Measured: First year of life of newborns
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start23 Oct 2017
- Primary completion16 Jun 2022
- Study completion16 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Definition and design. Prospective, double-blind randomised study. Population Pregnant women admitted for TPL between weeks 24.0 and 34.6 of gestation at the participating centre.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal-Infantil Vall d´Hebron Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689166
- Sponsor's protocol ID
- PR(AMI)236/2016
- Acronym
- PROPEV
- Status last verified
- Sep 2022
- First submitted
- 11 Feb 2018
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will allow us to determine whether the use of probiotics in pregnant women with TPL is associated with an increased risk of PB. If so, it would allow us to act on the tertiary prevention of PB and treatment of TPL, the main cause of perinatal morbidity and mortality in our setting. Similarly, it will facilitate understanding of the pathophysiology of PB, influence of vaginal microbiota and the mechanism of action of probiotics.
Publications
Del Barco E, Molano LG, Vargas M, Miserachs M, Puerto L, Garrido-Gimenez C, Soler Z, Munoz B, Pratcorona L, Rimbaut S, Vidal M, Dalmau M, Casellas A, Carreras E, Manichanh C, Goya M. The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial). Biomedicines. 2025 May 8;13(5):1141. doi: 10.3390/biomedicines13051141.
PubMed 40426968
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on the Preterm Delivery Rate (< 37 Weeks) in Pregnant Women at High Risk for Preterm Birth (Pregnant Women With Threatened Preterm Labour): PROPEV TRIAL Protocol
- ClinicalTrials.gov ID
- NCT03689166
- Acronym / sponsor ID
- PROPEV / PR(AMI)236/2016
- Conditions
- Preterm Birth
- Keywords
- Probiotics, Preterm birth, Threatened preterm labour
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Maternal-Infantil Vall d´Hebron HospitalUniversity, hospital or other
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 16 Jun 2022 (actual)
- Study completion
- 16 Jun 2022 (actual)
- First posted
- 28 Sep 2018 (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.
Preterm birth (PB) continues to be the main cause of perinatal morbidity and mortality, with emotional and economic consequences. Despite improvements in health, PB prevalence remains stable, possibly due to complex causes such as maternal age, stress, multiparity, etc. Shortening of the uterine cervix in early stages of gestation is a risk factor for PB. The presence of abnormal vaginal microbiota in the early stages of pregnancy is als a risk factor for PB. However, no studies have analysed the impact of probiotics (live microorganisms which, in adequate amounts, confer a health benefit on the host) on the PB in high-risk PB patients (pregnant women with threatened preterm delivery, i.e., uterine contractions and cervical shortening, with a 30% PB risk before 34 weeks, and 50% PB prior to 37 weeks (> 6-10% PB). Similarly, the effect of probiotics on vaginal flora dominated by lactic acid-producing bacteria could be analysed.
Detailed description
Hypothesis
- Pregnant women with threatened preterm labour (TPL) will present vaginal microbiome different from those without TPL.
- Treatment with probiotics will modify the vaginal microbioma of pregnant women with TPL.
- The PB rate before 37 weeks in pregnant women with TPL who have received probiotics since their diagnosis will be reduced by at least 30%.
Goals
- To correlate the use of probiotics of pregnant women with TPL with the PB rate before 37 weeks.
- To ascertain the PB rate before 28, 30, 32 and 34 weeks in both groups.
- To assess neonatal morbidity between both groups.
Methods
Prospective, randomised, longitudinal, prospective, double-blind study.
Relevance
This study will determine whether the use of probiotics in pregnant women with TPL is associated with a lower risk of PB before 37 weeks. If so, it would allow us to act on the tertiary prevention of PB and treatment of TPL, the main cause of perinatal morbidity and mortality in our setting. It will also facilitate understanding of the pathophysiology of PB, influence of vaginal microbiota and the mechanism of action of probiotics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Definition and design. Prospective, double-blind randomised study. Population Pregnant women admitted for TPL between weeks 24.0 and 34.6 of gestation at the participating centre.
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Active comparator | Dietary Supplement: ProbioticProbiotic drug |
| Control group | Placebo comparator | Other: PlaceboThis group will receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Threatened preterm labour: regular clinical and cardiotography-registered uterine dynamics, and cervical modifications (cervical shortening ≤ 25 mm between 24 and 29 weeks, and ≤ 15 mm between 30 and 34 weeks) according to our care protocol.
- Single gestation.
- Echographically-normal foetal morphology.
- Minimum age 18 years.
- Ability to understand informed consent.
Key exclusion criteria (3 listed)
- Multiple gestations.
- Pregnant women with diagnosis of chorioamnionitis.
- Cervical dilation.
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 |
|---|---|---|
| ProbioticReduce preterm birth with this dietary supplement | Dietary supplement | Probiotics group |
| PlaceboPlacebo | Other | Control group |
Primary outcome
Preterm birth rate <37 weeks
Time frame: From 24 to 37 weeks
To evaluate the percentage of preterm birth in each group (in days of gestation)
5 secondary outcomes
Preterm birth rate <34 weeks
Time frame: From 24 to 34 weeks
Preterm birth rate <32 weeks
Time frame: From 24 to 32 weeks
Preterm birth rate <30 weeks
Time frame: From 24 to 30 weeks
Preterm birth rate <28 weeks
Time frame: From 24 to 38 weeks
Intergroup neonatal morbidity
Time frame: First year of life of newborns
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 16 Sep 2022.
- Derived from this study: PubMed 40426968Del Barco E, Molano LG, Vargas M, Miserachs M, Puerto L, Garrido-Gimenez C, Soler Z, Munoz B, Pratcorona L, Rimbaut S, Vidal M, Dalmau M, Casellas A, Carreras E, Manichanh C, Goya M. The Effect of Probiotics on Preterm Birth Rates in Pregnant Women After a Threatened Preterm Birth Episode (The PROPEV Trial). Biomedicines. 2025 May 8;13(5):1141. doi: 10.3390/biomedicines13051141.
- Individual participant dataSharing planned: No. This study will allow us to determine whether the use of probiotics in pregnant women with TPL is associated with an increased risk of PB. If so, it would allow us to act on the tertiary prevention of PB and treatment of TPL, the main cause of perinatal morbidity and mortality in our setting. Similarly, it will facilitate understanding of the pathophysiology of PB, influence of vaginal microbiota and the mechanism of action of probiotics.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Preterm Birth, run by Maternal-Infantil Vall d´Hebron Hospital at 1 site in Spain.
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 3 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 16 Sep 2022. 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 Spain. 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?
Preterm birth rate <37 weeks (time frame: From 24 to 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689166, which also lists 1 linked publication.
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 16 Sep 2022.