Preterm BirthPhase 3OPTIM-PTLNCT04831086
To Optimize Antenatal Management of Women With Pre Term Labor Using Amniocentesis
A Phase 3 study testing Steroid Drug and Tocolytic Agents in people with Preterm Birth and Preterm Labor, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial summary
Implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection in women with preterm labor and intact membranes Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Preterm Labor, Intra-amniotic Infection
- What is being tested?
- Steroid Drug and Tocolytic Agents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteSpain
- Study dates
- 5 May 2021to 30 Dec 2024
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria.
Who cannot join
- Women who do no accept to be part of the study
- Maternal age < 18 years
- Multiple gestations
- Clinical chorioamnionitis at randomization (defined by the presence of fever above 38 celsius degrees (ºC), fetal tachycardia (>160 heart beat per minute >10 minutes), maternal White blood cells > 15000/mm3 (not justified by the administration of antenatal steroids).
- Cervical dilatation > 3 cm
- Major structural malformations of fetal complications that are related to neurodevelopmental impairment.
- Technical problems to perform an amniocentesis (prediction models include information from amniotic fluid: glucose and IL-6 concentration).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Optimize Antenatal Management of Women Admitted With Pre Term Labor and Intact Membranes Using Multivariable Prediction Models: Multicenter Randomised Control Trial (OPTIM-PTL)
Implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection in women with preterm labor and intact membranes
Read the detailed description
To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection:
- Optimises antenatal management (regarding steroids, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes.
- It is a cost-effective strategy.
- It improves neonatal outcome (in premature newborns <30 weeks), and reduces infectious maternal morbility.
- It improves neurodevelopmental outcome at 1.2 and 5 years.
- Conditions
- Preterm Birth, Preterm Labor, Intra-amniotic Infection, Amniocentesis Affecting Fetus or Newborn
- Being tested
- Steroid Drug, Tocolytic Agents
- Medical subject headings
- Premature Birth, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid DrugDrug
Steroids doses will be optimized in the intervention group according the risk based on predictive models
Tocolytic AgentsDrug
Tocolysis duration will be optimized in the intervention group according the risk based on predictive models
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In the intervention arm, the management will be optimized according to the risk of the predictive model. The predictive model of intra-amniotic infection includes maternal C-reactive protein (CRP) (in mg/L) and amniotic fluid glucose (in mg/dL), and the predictive model of spontaneous preterm delivery within 7 days includes gestational age (in weeks), cervical length (in mm), amniotic fluid glucose (in mg/dL) and Interleukin (IL)-6 (in a log10 scale). High risk will be defined when the risk is > 10% in the predictive model of spontaneous delivery in 7 days and > 20% in the predictive model of intra-amniotic infection:
1. If low-risk: we will optimize the standard management reducing the dose of steroids (e.g not administering second doses), tocolysis duration and facilitating discharge home.
2. If high-risk: we will follow the standard management of each center and we will treat with antibiotics Receives: Drug: Steroid Drug; Drug: Tocolytic Agents |
| Control | No intervention | In the control arm the standard management of each center will be followed regarding doses of steroids, duration of tocolysis or maternal stay length duration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antenatal steroid doses
Number of antenatal steroid doses administered
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
maternal stay length
Maternal length of hospital stay (in days).
Measured: through study completion, an average of 1 year
Clinical chorioamnionitis
Clinical chorioamnionitis occurrence defined by the presence of maternal fever >=38ºC, fetal tachycardia > 160 bpm, leukocytes > 14000/m2 without steroids effect and cervical purulent fluid
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start5 May 2021
- Primary completion30 Oct 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor and intact membranes between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria.
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Hospital Universitario La Fe, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Consorci Sanitari de Terrassa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Universitario Puerta del Mar, Hospital Sant Joan de Deu, Germans Trias i Pujol Hospital, University Hospital Virgen de las Nieves, Hospital Clínico Universitario Lozano Blesa, Parc Taulí Hospital Universitari, Complexo Hospitalario Universitario de A Coruña, Hospital Son Llatzer, Hospital Universitari Joan XXIII de Tarragona., Hospital Universitario de Torrejón, Madrid
- Responsible party
- Principal investigator, Teresa Cobo Cobo, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Teresa Cobo, MD, PhD, Principal investigator, Fundació Recerca Biomèdica Clínica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831086
- Sponsor's protocol ID
- OPTIM-PTL
- Acronym
- OPTIM-PTL
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2021
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Cobo T, Aldecoa V, Figueras F, Herranz A, Ferrero S, Izquierdo M, Murillo C, Amoedo R, Rueda C, Bosch J, Martinez-Portilla RJ, Gratacos E, Palacio M. Development and validation of a multivariable prediction model of spontaneous preterm delivery and microbial invasion of the amniotic cavity in women with preterm labor. Am J Obstet Gynecol. 2020 Sep;223(3):421.e1-421.e14. doi: 10.1016/j.ajog.2020.02.049. Epub 2020 Mar 5.
PubMed 32147290Cobo T, Aldecoa V, Bartha JL, Bugatto F, Paz Carrillo-Badillo M, Comas C, Diago-Almeda V, Ferrero S, Goya M, Herraiz I, Marti-Malgosa L, Olivella A, Paules C, Vives A, Figueras F, Palacio M, Gratacos E; OPTIM-PTL group. Assessment of an intervention to optimise antenatal management of women admitted with preterm labour and intact membranes using amniocentesis-based predictive risk models: study protocol for a randomised controlled trial (OPTIM-PTL Study). BMJ Open. 2021 Sep 28;11(9):e054711. doi: 10.1136/bmjopen-2021-054711.
PubMed 34588268
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Optimize Antenatal Management of Women Admitted With Pre Term Labor and Intact Membranes Using Multivariable Prediction Models: Multicenter Randomised Control Trial (OPTIM-PTL)
- ClinicalTrials.gov ID
- NCT04831086
- Acronym / sponsor ID
- OPTIM-PTL / OPTIM-PTL
- Conditions
- Preterm Birth, Preterm Labor, Intra-amniotic Infection, Amniocentesis Affecting Fetus or Newborn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Collaborators
- Hospital Vall d'Hebron, Hospital Universitario La Fe, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Consorci Sanitari de Terrassa, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Hospital Universitario Puerta del Mar, Hospital Sant Joan de Deu, Germans Trias i Pujol Hospital, University Hospital Virgen de las Nieves, Hospital Clínico Universitario Lozano Blesa, Parc Taulí Hospital Universitari, Complexo Hospitalario Universitario de A Coruña, Hospital Son Llatzer, Hospital Universitari Joan XXIII de Tarragona., Hospital Universitario de Torrejón, Madrid
- Study start
- 5 May 2021 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 5 Apr 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.
Implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection in women with preterm labor and intact membranes
Detailed description
To evaluate whether the implementation of prediction models of risk of spontaneous delivery within 7 days or of intra-amniotic infection:
- Optimises antenatal management (regarding steroids, tocolysis, antibiotics, maternal length stay duration) without worsening perinatal outcomes.
- It is a cost-effective strategy.
- It improves neonatal outcome (in premature newborns <30 weeks), and reduces infectious maternal morbility.
- It improves neurodevelopmental outcome at 1.2 and 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor and intact membranes between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Steroid Drug, Drug: Tocolytic AgentsIn the intervention arm, the management will be optimized according to the risk of the predictive model. The predictive model of intra-amniotic infection includes maternal C-reactive protein (CRP) (in mg/L) and amniotic fluid glucose (in mg/dL), and the predictive model of spontaneous preterm delivery within 7 days includes gestational age (in weeks), cervical length (in mm), amniotic fluid glucose (in mg/dL) and Interleukin (IL)-6 (in a log10 scale). High risk will be defined when the risk is > 10% in the predictive model of spontaneous delivery in 7 days and > 20% in the predictive model of intra-amniotic infection: 1. If low-risk: we will optimize the standard management reducing the dose of steroids (e.g not administering second doses), tocolysis duration and facilitating discharge home. 2. If high-risk: we will follow the standard management of each center and we will treat with antibiotics |
| Control | No intervention | –In the control arm the standard management of each center will be followed regarding doses of steroids, duration of tocolysis or maternal stay length duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women with singleton pregnancies admitted with a diagnosis of preterm labor between 23.0 and 34.6 weeks, not in labor at randomization and who do not meet exclusion criteria.
Key exclusion criteria (7 listed)
- Women who do no accept to be part of the study
- Maternal age < 18 years
- Multiple gestations
- Clinical chorioamnionitis at randomization (defined by the presence of fever above 38 celsius degrees (ºC), fetal tachycardia (>160 heart beat per minute >10 minutes), maternal White blood cells > 15000/mm3 (not justified by the administration of antenatal steroids).
- Cervical dilatation > 3 cm
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 |
|---|---|---|
| Steroid DrugSteroids doses will be optimized in the intervention group according the risk based on predictive models | Drug | Intervention |
| Tocolytic AgentsTocolysis duration will be optimized in the intervention group according the risk based on predictive models | Drug | Intervention |
Primary outcome
Antenatal steroid doses
Time frame: through study completion, an average of 1 year
Number of antenatal steroid doses administered
2 secondary outcomes
maternal stay length
Time frame: through study completion, an average of 1 year
Clinical chorioamnionitis
Time frame: through study completion, an average of 1 year
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 12 Mar 2025.
- Results publication: PubMed 32147290Cobo T, Aldecoa V, Figueras F, Herranz A, Ferrero S, Izquierdo M, Murillo C, Amoedo R, Rueda C, Bosch J, Martinez-Portilla RJ, Gratacos E, Palacio M. Development and validation of a multivariable prediction model of spontaneous preterm delivery and microbial invasion of the amniotic cavity in women with preterm labor. Am J Obstet Gynecol. 2020 Sep;223(3):421.e1-421.e14. doi: 10.1016/j.ajog.2020.02.049. Epub 2020 Mar 5.
- Derived from this study: PubMed 34588268Cobo T, Aldecoa V, Bartha JL, Bugatto F, Paz Carrillo-Badillo M, Comas C, Diago-Almeda V, Ferrero S, Goya M, Herraiz I, Marti-Malgosa L, Olivella A, Paules C, Vives A, Figueras F, Palacio M, Gratacos E; OPTIM-PTL group. Assessment of an intervention to optimise antenatal management of women admitted with preterm labour and intact membranes using amniocentesis-based predictive risk models: study protocol for a randomised controlled trial (OPTIM-PTL Study). BMJ Open. 2021 Sep 28;11(9):e054711. doi: 10.1136/bmjopen-2021-054711.
- Predictive models of spontaneous delivery within 7 days and of intra-amniotic infections descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Teresa Cobo, MD, PhD principal investigator
Fundació Recerca Biomèdica Clínica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Steroid Drug and Tocolytic Agents in people with Preterm Birth and Preterm Labor, run by Fundacion Clinic per a la Recerca Biomédica 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 1 inclusion and 7 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 12 Mar 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Antenatal steroid doses (time frame: through study completion, an average of 1 year). 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 NCT04831086, which also lists 2 linked publications.
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 12 Mar 2025.