Clinical trial NCT03062020: New Tool to Predict Risk of Spontaneous Preterm Birth in Asymptomatic High-risk Women
Official title: New Tool to Predict Risk of Spontaneous Preterm Birth in Asymptomatic High-risk Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PreTerm Birth
Keywords: Preterm Birth
Asymptomatic high-risk women
QUIPP
Quantitative fetal fibronectin
Cervical length
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 258
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Spontaneous preterm birth before 34.0 and 37.0 weeks of gestation
timeFrame: 3.5 years
Secondary outcomes:
measure: Gestational age at delivery
timeFrame: 3,5 years
measure: Hospital admission due to sPTB or PPROM
timeFrame: 3.5 years
measure: Emergency department visits due to uterine contractions
timeFrame: 3.5 years
measure: Clinical chorioamnionitis
timeFrame: 3.5 years
measure: Maternal mortality
timeFrame: 3.5 years
measure: 5 min APGAR score <7
timeFrame: 3.5 years
measure: umbilical artery pH at delivery <7.1
timeFrame: 3.5 years
measure: NCIU admission
timeFrame: 3.5 years
measure: Need for respiratory support
timeFrame: 3.5 years
measure: Respiratory distress syndrome
timeFrame: 3.5 years
measure: Intraventricular haemorrhage
timeFrame: 3.5 years
measure: Necrotizing enterocolitis
timeFrame: 3.5 years
measure: Neonatal sepsis
timeFrame: 3.5 years
measure: Neonatal mortality
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic Barcelona ( Maternitat)
Study officials:
affiliation: BCNatal | Barcelona Center for Maternal Fetal and Neonatal Medicine | Hospital Clínic - Hospital Sant Joan de Déu
name: Núria Lorente, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Abbott 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.
citation: Kuhrt 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.