Reduced fetal Movements Intervention Trial

Not Applicable

Completed

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

• Registration Number: ISRCTN07944306
• Lead Sponsor: Central Manchester University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-12
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of women with poor pregnancy outcome <br>2. Poor pregnancy outcome is defined as:<br>2.1. Stillbirth<br>2.2. Unexpected admission to the neonatal intensive care unit<br>2.3. Metabolic acidosis (umbilical arterial cord pH <7.1)

Secondary Outcome Measures

Name	Time	Method
1. Proportion of infants with a birthweight centile < 10<br>2. Proportion of eligible women recruited to the study (feasibility)<br>3. Anxiety scores and views of women before and after their assigned treatment (acceptability)<br>4. Views of medical and midwifery staff on the intervention