Prediction of the Onset of Term and Preterm Labour (NCT04590677) | Clinical Trial Compass
UnknownNot Applicable
Prediction of the Onset of Term and Preterm Labour
United Kingdom200 participantsStarted 2020-10-20
Plain-language summary
This study will collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour.
Who can participate
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)…
What they're measuring
1
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.
Trial details
NCT IDNCT04590677
SponsorChelsea and Westminster NHS Foundation Trust