New Tool to Predict Risk of Spontaneous Preterm Birth in Asymptomatic High-risk Women

NCT03062020 | Unknown

• 1 other identifier: HCB/2016/0552
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 2

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.

Conditions

PreTerm Birth

Keywords

Preterm Birth; Asymptomatic high-risk women; QUIPP; Quantitative fetal fibronectin; Cervical length

Outcome Measures

Primary Outcomes (1)

• Spontaneous preterm birth before 34.0 and 37.0 weeks of gestation

  Delivery \< 34.0 and \<37.0 weeks of gestation ( Yes/No )

  3.5 years

Secondary Outcomes (14)

• Gestational age at delivery

  3,5 years

• Hospital admission due to sPTB or PPROM

  3.5 years

• Emergency department visits due to uterine contractions

  3.5 years

• Clinical chorioamnionitis

  3.5 years

• Maternal mortality

  3.5 years

Study Arms (2)

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.

Device: QUIPP

Control group: no QUIPP tool arm

NO INTERVENTION

Women will be managed according to current clinical practice.

Interventions

QUIPP DEVICE

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.

Intervention group: QUIPP tool arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (2)

Hospital Clínic Barcelona ( Maternitat)

Barcelona, Barcelona, 08028, Spain

RECRUITING

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08950, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 19254585 BACKGROUND

• 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.

  PMID: 25932845 BACKGROUND

• 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.

  PMID: 25846437 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Núria Lorente, M.D

  BCNatal | Barcelona Center for Maternal Fetal and Neonatal Medicine | Hospital Clínic - Hospital Sant Joan de Déu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Núria Lorente, M.D

CONTACT

+34932532100; nlorente@sjdhospitalbarcelona.org

Montse Palacio, M.D, Ph.D

CONTACT

+3493 227 9946; MPALACIO@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor. Physician Doctor. Senior consultant

Study Record Dates

• First Submitted: November 29, 2016
• First Posted: February 23, 2017
• Study Start: November 16, 2016
• Primary Completion: November 1, 2020
• Study Completion: June 1, 2021
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)