Prediction of the Onset of Term and Preterm Labour

Preterm Birth Clinical Trial

— PREDICT  

Official title:

Prediction of the Onset of Term and Preterm Labour (PREDICT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04590677
• Other study ID #: C&W19/037
• Status: Recruiting
• Start date: October 20, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2021
• Source: Chelsea and Westminster NHS Foundation Trust
• Contact: Research Delivery Operations Manager
• Phone: 020 3315 6825
• Email: research.development[@]chewest.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Obstetric Labor, Premature
• Premature Birth
• Preterm Birth
• Preterm Birth Complication
• Preterm Labor
• Preterm Pregnancy
• Preterm Premature Rupture of Membrane
• Rupture

Intervention

Other:
• Samples required from group 1 (procedure within observational study)
Weekly maternal blood samples to be taken Daily urine samples to be collected One rectal swab at the initial visit only Weekly vaginal swabs Daily Heart rate monitoring (only applicable to a subset of women in group 1)
• Samples required from group 2 (procedure within observational study)
Weekly maternal blood samples to be taken Daily urine samples to be collected One rectal swab at the initial visit only Weekly vaginal swabs

Locations

Country	Name	City	State
United Kingdom	Chelsea and Westminster Hospital	London

Sponsors (3)

Lead Sponsor	Collaborator
Chelsea and Westminster NHS Foundation Trust	Borne Charity, SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in biomarker concentration with respect to gestational age of onset of term and preterm labour	To use a combination of maternal blood, urine, rectal and vaginal swabs from pregnant to develop a biomarker to allow prediction of women at risk of preterm birth.	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	Optimal thresholds for each biomarker and estimated associated sensitivity, specificity of each biomarker	To determine the temporal relationship between concentration of each biomarker e.g. hCG (IU/L), Progesterone (µg/ml) and onset of labour.; For biomarkers that demonstrate a clinically relevant relationship with onset of labour e.g. hCG (IU/L), Progesterone (µg/ml), the clinical utility of the biomarker will be determined.	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	Correlation between the percentage of patients with reported demographic variables, lifestyle variables and clinical symptoms	To determine the correlation between the percentage of patients with reported demographic variables, lifestyle variables and clinical symptoms reported through questionnaires and a daily diary and the onset of preterm birth.	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.