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Reduced fetal Movements Intervention Trial
ISRCTN ISRCTN07944306
DOI 10.1186/ISRCTN07944306
ClinicalTrials.gov identifier
EudraCT number
Public title Reduced fetal Movements Intervention Trial
Scientific title A pilot randomised controlled trial to determine whether intensive investigation for women presenting with reduced fetal movements after 36 weeks gestation reduces the incidence of poor pregnancy outcome compared to standard management.
Acronym ReMIT
Serial number at source 1.41
Study hypothesis We hypothesise that intensive investigation of women with reduced fetal movements by ultrasound scan measurement of the baby’s size, liquor volume, detailed assessment of the placenta and with measurement of the placental marker, human placental lactogen (hPL) will improve prediction of poor pregnancy outcome, and that recommendation of delivery based on these indices will reduce the incidence of poor pregnancy outcome.
Lay summary Lay summary under review 3
Ethics approval United Kingdom National Research Ethics Service, NRES Committee North West - Greater Manchester Central Committee
Study design Single centre non-blinded randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Stillbirth, Perinatal Death
Participants - inclusion criteria Women presenting with a subjective reduction in fetal movements between 36+0 and 41+3 weeks gestation with a viable singleton pregnancy on initial assessment.
Participants - exclusion criteria 1. Fetus with a congenital anomaly
2. Multiple pregnancy
3. Fetus requiring immediate delivery for abnormal fetal heart rate trace
4. Maternal age <16 years
5. Women unable to give informed consent
Anticipated start date 01/11/2011
Anticipated end date 01/11/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 120
Interventions Intervention Group - intensive investigation specifically ultrasound assessment of estimated fetal weight, liquor volume, umbilical artery Doppler and measurement of human placental lactogen with recommendation to deliver the infant if any of these indices are abnormal.

Control Group - standard treatment as outlined in the guidelines from the Royal College of Obstetricians and Gynaecologists.
Primary outcome measure(s) 1. Proportion of women with poor pregnancy outcome
2. Poor pregnancy outcome is defined as:
2.1. Stillbirth
2.2. Unexpected admission to the neonatal intensive care unit
2.3. Metabolic acidosis (umbilical arterial cord pH <7.1)
Secondary outcome measure(s) 1. Proportion of infants with a birthweight centile < 10
2. Proportion of eligible women recruited to the study (feasibility)
3. Anxiety scores and views of women before and after their assigned treatment (acceptability)
4. Views of medical and midwifery staff on the intervention
Sources of funding 1. Manchester Biomedical Research Centre (UK)
2. Central Manchester University Hospitals NHS Foundation Trust (UK) (ref: R01519)
Trial website
Publications 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23590451
Contact name Dr  Alexander  Heazell
  Address Maternal and Fetal Health Research Centre
5th Floor (Research)
St Mary's Hospital
Oxford Road
  City/town Manchester
  Zip/Postcode M13 9WL
  Country United Kingdom
Sponsor Central Manchester University Hospitals NHS Foundation Trust (UK)
  Address Research and Innovation Directorate
1st Floor
Postgradute Centre
Oxford Road
  City/town Manchester
  Zip/Postcode M13 9WL
  Country United Kingdom
  Sponsor website: http://www.cmft.nhs.uk/
Date applied 24/08/2011
Last edited 07/05/2013
Date ISRCTN assigned 12/09/2011
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