Clinical trial NCT04590677: Prediction of the Onset of Term and Preterm Labour
Official title: Prediction of the Onset of Term and Preterm Labour (PREDICT)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Pregnancy
Preterm Birth
Preterm Birth Complication
Preterm Premature Rupture of Membrane
Preterm Labor
Keywords: Preterm
Biomarker
Pregnancy
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: SPD Development Company Limited
name: Borne Charity
First posted: 2020-10-19
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: This study will collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour.

Detailed description: Preterm birth is not a single entity but rather multifactorial The mechanisms underlying preterm birth are multifactorial and include stretch, oxidative stress, inflammation, infection and thrombosis. 85% of women have no identifiable risk factors for preterm birth and there is a requirement to develop a biomarker which can be used early in pregnancy to identify such women at risk. Equally important is to have a detection tool which will allow us to offer an individualised approach to preterm birth prevention and the women to benefit personalised surveillance and timely preventative measures such as cervical cerclage or progesterone.

The aim of this study is to collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour. We will use maternal blood, urine and vaginal secretion to look for biomarkers in these samples which can be use in the clinical setting to determine which women will go on to give birth preterm. This will allow clinicians to correctly identify these women and initiate treatment in the right woman to prevent preterm labour and birth. Equally important it will reduce unnecessary intervention and admission in those women who are not at risk.

Eligibility criteria: Group 1 inclusion criteria

* Pregnant woman
* 36 weeks gestational age

Group 1 exclusion criteria

* Risk factors for preterm birth (previous preterm birth or second trimester loss, cervical suture, previous cervical treatment, previous full dilatation caesarean, transabdominal suture).
* Planned Caesarean Section
* Any high-risk pregnancy conditions such as PET (pre-eclamptic toxaemia), OC (Obstetric cholestasis), FGR (fetal growth restriction)
* Unable to read written English
* Unable to provide informed consent
* Poor attendance with antenatal care
* Uncertain gestational age

Exclusion criteria for subset within group 1 using heart rate monitor

* Does not have access to an Apple iPhone or iPad with Bluetooth 4.0 (or later) and iOS 10.0 (or later)
* Skin condition where there is sensitivity to wearing a skin monitor
* Known heart condition or use of a pacemaker
* Taking any medications that may affect heart rate

Group 2 inclusion criteria

* Pregnant woman
* Presenting at or after 24 weeks gestational age and before 36 weeks / Symptoms of threatened preterm labour (abdominal pain) with fetal fibronectin level ≥ 50 ng/mL and without rupture of membranes
* In-utero transfer with suspected threatened preterm labour with evidence of cervical shortening and dilatation with or without a fetal fibronectin
* Rupture of membranes with or without contractions

Group 2 exclusion criteria

* Any high-risk pregnancy conditions such as PET (pre-eclampsia), OC (Obstetric cholestasis), FGR (fetal growth restriction)
* Unable to read written English
* Unable to provide informed consent
* Poor compliance with antenatal care
* Uncertain gestational age

Primary outcomes:
measure: Relative change in biomarker concentration with respect to gestational age of onset of term and preterm labour
timeFrame: Group 1 from 36 weeks until delivery (approximately 6 weeks). Group 2 from admission at or beyond 24 weeks gestation until 42 weeks of gestation if not delivered.
Secondary outcomes:
measure: Optimal thresholds for each biomarker and estimated associated sensitivity, specificity of each biomarker
timeFrame: Group 1 from 36 weeks until delivery (approximately 6 weeks). Group 2 from admission at or beyond 24 weeks gestation until 42 weeks of gestation if not delivered.
measure: Correlation between the percentage of patients with reported demographic variables, lifestyle variables and clinical symptoms
timeFrame: Group 1 from 36 weeks until delivery (approximately 6 weeks). Group 2 from admission at or beyond 24 weeks gestation until 42 weeks of gestation if not delivered.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
Study officials:
affiliation: Chelsea and Westminster NHS Foundation Trust
name: Natasha Singh, MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngo TTM, Moufarrej MN, Rasmussen MH, Camunas-Soler J, Pan W, Okamoto J, Neff NF, Liu K, Wong RJ, Downes K, Tibshirani R, Shaw GM, Skotte L, Stevenson DK, Biggio JR, Elovitz MA, Melbye M, Quake SR. Noninvasive blood tests for fetal development predict gestational age and preterm delivery. Science. 2018 Jun 8;360(6393):1133-1136. doi: 10.1126/science.aar3819.
citation: Heng YJ, Di Quinzio MK, Permezel M, Rice GE, Georgiou HM. Interleukin-1 receptor antagonist in human cervicovaginal fluid in term pregnancy and labor. Am J Obstet Gynecol. 2008 Dec;199(6):656.e1-7. doi: 10.1016/j.ajog.2008.06.011. Epub 2008 Jul 21.
citation: Heng YJ, Di Quinzio MK, Permezel M, Rice GE, Georgiou HM. Cystatin A protease inhibitor and cysteine proteases in human cervicovaginal fluid in term pregnancy and labor. Am J Obstet Gynecol. 2011 Mar;204(3):254.e1-7. doi: 10.1016/j.ajog.2010.10.912. Epub 2010 Dec 16.