PreTerm BirthNCT03062020
New Tool to Predict Risk of Spontaneous Preterm Birth in Asymptomatic High-risk Women
A study testing QUIPP in people with PreTerm Birth, run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial summary
The QUIPP tool integrates information of obstetrical history, quantitative fetal fibronectin (qfFN) and cervical length to predict the risk of sPTB in asymptomatic high-risk women. 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
- What is being tested?
- QUIPP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 2 sitesSpain
- Study dates
- 16 Nov 2016to Jun 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Asymptomatic singleton pregnancies, with at least one of the following: Previous spontaneous preterm delivery or a preterm premature rupture of membranes ≤ 346 weeks of gestation, Previous spontaneous second trimester miscarriage, Previous surgery on uterine cervix, Incidental finding of cervical length less than 25mm, Uterine malformations.
- Able to sign informed consent form.
Who cannot join
- Multiple pregnancies.
- Congenital, chromosomal abnormalities or stillbirth in current pregnancy.
- No patient consent to participate in the study
- Women with an obstetrical history of iatrogenic preterm birth indicated for maternal or fetal conditions.
- Symptomatic high-risk women or preterm prelabor rupture of membranes in current pregnancy.
- Pregnant women with an indication of prophylactic cervical cerclage due to her own obstetrical history.
- Pregnant women with a short cervix detected by ultrasound and with an indication to perform a cervical cerclage, prior to study inclusion.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clínic Barcelona ( Maternitat)
Barcelona, Barcelona, 08028
Montse Palacio, M.D, Ph.D, +34932279946 ext. 9904, MPALACIO@clinic.cat
Teresa Cobo, M.D, Ph. D
- Recruiting
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
Núria Lorente, M.D, +34932532100, nlorente@sjdbarcelonahospital.org
Núria Lorente, M.D
About this study
The QUIPP tool integrates information of obstetrical history, quantitative fetal fibronectin (qfFN) and cervical length to predict the risk of sPTB in asymptomatic high-risk women.
The aim of this study is to evaluate the QUIPP tool in our setting in order to optimize the management of women at high risk for sPTB and to validate in a randomized clinical trial, whether the use of QUIPP improves efficiently the management of our asymptomatic high-risk women when it is compared with the current clinical management.
Read more
Design: Randomized controlled trial. Inclusion criteria: Asymptomatic singleton pregnancies 18,0-22,6 weeks at high-risk for sPTB. Sample size: According to a non-inferiority analysis, 129 pregnant women will be needed for each arm.
Methodology: Patient selection and who consent to participate in the study will be randomized into two arms: a) Intervention group: QUIPP tool will be used to select and manage patients attending our PBPC: high-risk patients will be followed-up in our PBPC and low-risk patients will be discharged from PBPC and managed in a low-risk unit. b) Control group: Women will be managed according to current clinical practice.
Main Outcome: sPTB <34,0 and <37,0 weeks of gestation. Secondary Outcomes: Pregnancy outcomes and a neonatal composite morbidity. Expected Results: Perinatal outcomes are similar in the intervention and control group although the intervention group using the QUIPP tool required less medical resources.
Read the detailed description
Preterm birth (PTB) is a leading cause of perinatal morbidity and mortality. Women at high-risk of preterm birth are those with a previous spontaneous preterm birth (sPTB) or preterm premature rupture of membranes before 35 weeks of gestation, uterine malformation, surgery on uterine cervix or a short cervical length; these women have a global risk of PTB about 30% but still 75%-85% of these women will deliver at term without any intervention.
The availability of a specialized Preterm Birth Prevention Clinic (PBPC) is relevant for the management of these high-risk pregnant women and it results in a reduction in the risk of recurrent sPTB, pregnancy prolongation and a reduction in the rate of major neonatal morbidity. However, it implies higher outpatient care costs as well as trained personnel and intensive follow-up management even for those women not destined to deliver preterm QUIPP is a free smartphone application that integrates the obstetrical history of high-risk women, the cervical length and the value of quantitative fetal fibronectin to predict the risk of preterm birth. QUIPP will determinate the risk of preterm birth in these high-risk women.
Patients will be randomized in two groups: Intervention group (QUIPP tool arm): QUIPP tool is applied and patients with a high-risk result will be follow-up in a high-risk unit (PBPC) and patients with a low-risk value will be managed in a low-risk unit. Control group (no QUIPP tool arm): current management in a PBPC will be applied.
The use of QUIPP will allow determining which asymptomatic pregnancies with risk factors for sPTB will deliver preterm. Furthermore, we expect to provide the non-specialized clinician with an objective, useful, accurate and efficient tool to manage these women with same pregnancy and neonatal outcomes and using less resource.
- Conditions
- PreTerm Birth
- Being tested
- QUIPP
- Keywords
- Preterm Birth, Asymptomatic high-risk women, QUIPP, Quantitative fetal fibronectin, Cervical length
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUIPPDevice
Information required by QUIPP tool will be introduced ( obstetrical history, cervical length and quantitative fetal fibronectin value) and a percentage of risk of preterm birth will be given. Women with a high-risk value will be managed in Preterm Birth Prevention Clinic and women with low-risk value will be followed-up in a low-risk unit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: QUIPP tool arm | Experimental | In this group, QUIPP tool will be used to select and manage patients attending our PBPC: high-risk patients will be followed-up in our PBPC and low-risk patients will be discharged from PBPC and managed in a low-risk unit. Receives: Device: QUIPP |
| Control group: no QUIPP tool arm | No intervention | Women will be managed according to current clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous preterm birth before 34.0 and 37.0 weeks of gestation
Delivery < 34.0 and <37.0 weeks of gestation ( Yes/No )
Measured: 3.5 years
Secondary outcomes (14)
Gestational age at delivery
Weeks and days at the moment of delivery
Measured: 3,5 years
Hospital admission due to sPTB or PPROM
Number of hospital admission due to a spontaneous preterm labor or a preterm premature rupture of membranes
Measured: 3.5 years
Emergency department visits due to uterine contractions
Number of emergency department visits
Measured: 3.5 years
Clinical chorioamnionitis
Fever ( >37.8 ºC) and maternal tachycardia ( >100 beats per minute) and /or fetal tachycardia ( >160 beats per minute) and/or maternal leukocytosis ( >15000 leukocites/mm3) and/or uterine contractions and/or malodorous leukorrhea
Measured: 3.5 years
Maternal mortality
Maternal death (Yes/No)
Measured: 3.5 years
5 min APGAR score <7
APGAR test less than 7 at the 5 minuts after birth
Measured: 3.5 years
umbilical artery pH at delivery <7.1
pH artery value less than 7.1
Measured: 3.5 years
NCIU admission
Admission in a neonatal intensive care unit ( Yes/No)
Measured: 3.5 years
Need for respiratory support
Administration of respiratory support during the NCIU stay.
Measured: 3.5 years
Respiratory distress syndrome
Breathing disorder ( Yes /No)
Measured: 3.5 years
Intraventricular haemorrhage
Severe intraventricular haemorrhage grade III/IV
Measured: 3.5 years
Necrotizing enterocolitis
Intestinal necrosis in the newborn ( Yes/No)
Measured: 3.5 years
Neonatal sepsis
Blood infection of the newborn (Yes/No)
Measured: 3.5 years
Neonatal mortality
neonatal death
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start16 Nov 2016
- Primary completionNov 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PreTerm BirthStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montse Palacio, Hospital Clinic of Barcelona
- Investigators
- Núria Lorente, M.D, Principal investigator, BCNatal | Barcelona Center for Maternal Fetal and Neonatal Medicine | Hospital Clínic - Hospital Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062020
- Sponsor's protocol ID
- HCB/2016/0552
- Status last verified
- Feb 2017
- First submitted
- 29 Nov 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurtzman J, Chandiramani M, Briley A, Poston L, Das A, Shennan A. Quantitative fetal fibronectin screening in asymptomatic high-risk patients and the spectrum of risk for recurrent preterm delivery. Am J Obstet Gynecol. 2009 Mar;200(3):263.e1-6. doi: 10.1016/j.ajog.2009.01.018.
PubMed 19254585Abbott DS, Hezelgrave NL, Seed PT, Norman JE, David AL, Bennett PR, Girling JC, Chandirimani M, Stock SJ, Carter J, Cate R, Kurtzman J, Tribe RM, Shennan AH. Quantitative fetal fibronectin to predict preterm birth in asymptomatic women at high risk. Obstet Gynecol. 2015 May;125(5):1168-1176. doi: 10.1097/AOG.0000000000000754.
PubMed 25932845Kuhrt K, Smout E, Hezelgrave N, Seed PT, Carter J, Shennan AH. Development and validation of a tool incorporating cervical length and quantitative fetal fibronectin to predict spontaneous preterm birth in asymptomatic high-risk women. Ultrasound Obstet Gynecol. 2016 Jan;47(1):104-9. doi: 10.1002/uog.14865.
PubMed 25846437
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Tool to Predict Risk of Spontaneous Preterm Birth in Asymptomatic High-risk Women
- ClinicalTrials.gov ID
- NCT03062020
- Acronym / sponsor ID
- HCB/2016/0552
- Conditions
- PreTerm Birth
- Keywords
- Preterm Birth, Asymptomatic high-risk women, QUIPP, Quantitative fetal fibronectin, Cervical length
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 23 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.
The QUIPP tool integrates information of obstetrical history, quantitative fetal fibronectin (qfFN) and cervical length to predict the risk of sPTB in asymptomatic high-risk women.
The aim of this study is to evaluate the QUIPP tool in our setting in order to optimize the management of women at high risk for sPTB and to validate in a randomized clinical trial, whether the use of QUIPP improves efficiently the management of our asymptomatic high-risk women when it is compared with the current clinical management.
Design: Randomized controlled trial. Inclusion criteria: Asymptomatic singleton pregnancies 18,0-22,6 weeks at high-risk for sPTB. Sample size: According to a non-inferiority analysis, 129 pregnant women will be needed for each arm.
Methodology: Patient selection and who consent to participate in the study will be randomized into two arms: a) Intervention group: QUIPP tool will be used to select and manage patients attending our PBPC: high-risk patients will be followed-up in our PBPC and low-risk patients will be discharged from PBPC and managed in a low-risk unit. b) Control group: Women will be managed according to current clinical practice.
Main Outcome: sPTB <34,0 and <37,0 weeks of gestation. Secondary Outcomes: Pregnancy outcomes and a neonatal composite morbidity. Expected Results: Perinatal outcomes are similar in the intervention and control group although the intervention group using the QUIPP tool required less medical resources.
Detailed description
Preterm birth (PTB) is a leading cause of perinatal morbidity and mortality. Women at high-risk of preterm birth are those with a previous spontaneous preterm birth (sPTB) or preterm premature rupture of membranes before 35 weeks of gestation, uterine malformation, surgery on uterine cervix or a short cervical length; these women have a global risk of PTB about 30% but still 75%-85% of these women will deliver at term without any intervention.
The availability of a specialized Preterm Birth Prevention Clinic (PBPC) is relevant for the management of these high-risk pregnant women and it results in a reduction in the risk of recurrent sPTB, pregnancy prolongation and a reduction in the rate of major neonatal morbidity. However, it implies higher outpatient care costs as well as trained personnel and intensive follow-up management even for those women not destined to deliver preterm QUIPP is a free smartphone application that integrates the obstetrical history of high-risk women, the cervical length and the value of quantitative fetal fibronectin to predict the risk of preterm birth. QUIPP will determinate the risk of preterm birth in these high-risk women.
Patients will be randomized in two groups: Intervention group (QUIPP tool arm): QUIPP tool is applied and patients with a high-risk result will be follow-up in a high-risk unit (PBPC) and patients with a low-risk value will be managed in a low-risk unit. Control group (no QUIPP tool arm): current management in a PBPC will be applied.
The use of QUIPP will allow determining which asymptomatic pregnancies with risk factors for sPTB will deliver preterm. Furthermore, we expect to provide the non-specialized clinician with an objective, useful, accurate and efficient tool to manage these women with same pregnancy and neonatal outcomes and using less resource.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: QUIPP tool arm | Experimental | Device: QUIPPIn this group, QUIPP tool will be used to select and manage patients attending our PBPC: high-risk patients will be followed-up in our PBPC and low-risk patients will be discharged from PBPC and managed in a low-risk unit. |
| Control group: no QUIPP tool arm | No intervention | –Women will be managed according to current clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Asymptomatic singleton pregnancies, with at least one of the following: Previous spontaneous preterm delivery or a preterm premature rupture of membranes ≤ 346 weeks of gestation, Previous spontaneous second trimester miscarriage, Previous surgery on uterine cervix, Incidental finding of cervical length less than 25mm, Uterine malformations.
- Able to sign informed consent form.
Key exclusion criteria (7 listed)
- Multiple pregnancies.
- Congenital, chromosomal abnormalities or stillbirth in current pregnancy.
- No patient consent to participate in the study
- Women with an obstetrical history of iatrogenic preterm birth indicated for maternal or fetal conditions.
- Symptomatic high-risk women or preterm prelabor rupture of membranes in current pregnancy.
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 |
|---|---|---|
| QUIPPInformation required by QUIPP tool will be introduced ( obstetrical history, cervical length and quantitative fetal fibronectin value) and a percentage of risk of preterm birth will be given. Women with a high-risk value will be managed in Preterm Birth Prevention Clinic and women with low-risk value will be followed-up in a low-risk unit. | Device | Intervention group: QUIPP tool arm |
Primary outcome
Spontaneous preterm birth before 34.0 and 37.0 weeks of gestation
Time frame: 3.5 years
Delivery < 34.0 and <37.0 weeks of gestation ( Yes/No )
14 secondary outcomes
Gestational age at delivery
Time frame: 3,5 years
Hospital admission due to sPTB or PPROM
Time frame: 3.5 years
Emergency department visits due to uterine contractions
Time frame: 3.5 years
Clinical chorioamnionitis
Time frame: 3.5 years
Maternal mortality
Time frame: 3.5 years
5 min APGAR score <7
Time frame: 3.5 years
umbilical artery pH at delivery <7.1
Time frame: 3.5 years
NCIU admission
Time frame: 3.5 years
Need for respiratory support
Time frame: 3.5 years
Respiratory distress syndrome
Time frame: 3.5 years
Intraventricular haemorrhage
Time frame: 3.5 years
Necrotizing enterocolitis
Time frame: 3.5 years
Neonatal sepsis
Time frame: 3.5 years
Neonatal mortality
Time frame: 3.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 19254585Kurtzman J, Chandiramani M, Briley A, Poston L, Das A, Shennan A. Quantitative fetal fibronectin screening in asymptomatic high-risk patients and the spectrum of risk for recurrent preterm delivery. Am J Obstet Gynecol. 2009 Mar;200(3):263.e1-6. doi: 10.1016/j.ajog.2009.01.018.
- Background: PubMed 25932845Abbott DS, Hezelgrave NL, Seed PT, Norman JE, David AL, Bennett PR, Girling JC, Chandirimani M, Stock SJ, Carter J, Cate R, Kurtzman J, Tribe RM, Shennan AH. Quantitative fetal fibronectin to predict preterm birth in asymptomatic women at high risk. Obstet Gynecol. 2015 May;125(5):1168-1176. doi: 10.1097/AOG.0000000000000754.
- Background: PubMed 25846437Kuhrt K, Smout E, Hezelgrave N, Seed PT, Carter J, Shennan AH. Development and validation of a tool incorporating cervical length and quantitative fetal fibronectin to predict spontaneous preterm birth in asymptomatic high-risk women. Ultrasound Obstet Gynecol. 2016 Jan;47(1):104-9. doi: 10.1002/uog.14865.
- Individual participant dataSharing planned: No
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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.
Núria Lorente, M.D principal investigator
BCNatal | Barcelona Center for Maternal Fetal and Neonatal Medicine | Hospital Clínic - Hospital Sant Joan de Déu
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QUIPP in people with PreTerm Birth, run by Hospital Clinic of Barcelona at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Núria Lorente, M.D (+34932532100, nlorente@sjdhospitalbarcelona.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous preterm birth before 34.0 and 37.0 weeks of gestation (time frame: 3.5 years). 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 NCT03062020, which also lists 3 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 23 Feb 2017.