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Reduced fetal Movements Intervention Trial

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN07944306
Enrollment
120
Registered
2011-09-12
Start date
2011-11-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stillbirth, Perinatal Death Pregnancy and Childbirth Maternal care related to the fetus and amniotic cavity and possible delivery problems

Interventions

Intervention Group - intensive investigation specifically ultrasound assessment of estimated fetal weight, liquor volume, umbilical artery Doppler and measurement of human placental lactogen with reco

Sponsors

Central Manchester University Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026