Condition category
Pregnancy and Childbirth
Date applied
24/08/2011
Date assigned
12/09/2011
Last edited
11/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Currently, 1 in 200 babies born after 24 weeks of pregnancy is stillborn. Despite improvements in pregnancy care, the rate of stillbirth is the same as 20 years ago. One reason is the lack of a test to identify which babies are most at risk of stillbirth. One symptom that mothers are commonly aware of before stillbirth is a reduction in their baby’s movements. We believe that a reduction in babies’ movements is a sign that they are receiving less nutrients and oxygen from their mother because the afterbirth (placenta) is working less well. The placenta in women who come to hospital with a reduction in baby’s movements is smaller, abnormally shaped and more damaged than those with normal movements. We believe that performing specialised tests on women who come to hospital because their baby’s movements have reduced could identify women whose babies are at most risk of stillbirth, allowing us to deliver them before they die. The aim of our study is to find out whether recommending delivery based on extra tests reduces the number of stillbirths and admissions to the neonatal intensive care unit (NICU), compared to the current standard practice. The extra tests are assessment of the baby’s size, the amount of water around the baby, the blood flow through the placenta and a blood test. By carrying out this initial study we will find out whether women will agree to participate in a study after coming to hospital with reduced baby movements and whether the tests and any associated treatment cause increased anxiety for mothers. We will also see whether the test results changed the way doctors and midwives cared for their patients. We will then be able to develop a larger study to see whether these tests can help prevent stillbirths.

Who can participate?
Women over 16 years of age who come to the maternity triage unit or maternity day unit at St Mary’s Hospital, Manchester with reduced baby movements between 36 weeks and 41 weeks 3 days of pregnancy.

What does the study involve?
Women are randomly allocated into one of two groups. In the current care group the women are checked by a midwife and if they meet certain criteria we perform an ultrasound scan for the baby’s size and the amount of water around the baby and the result is recorded. In the detailed assessment group the women have an ultrasound scan for the baby’s size, amount of water around the baby and blood flow through the placenta, appearance of the placenta and a blood test.

What are the potential benefits and risks of participating?
The additional tests might identify women at high risk of complications, allowing the baby to be delivered earlier. There are no known risks of having an extra scan or blood test in late pregnancy.

Where is the study run from?
St Mary’s Hospital, Manchester, UK.

When is the study starting and how long is it expected to run for?
November 2011 to November 2012.

Who is funding the study?
Manchester Biomedical Research Centre and Central Manchester University Hospitals NHS Foundation Trust (UK).

Who is the main contact?
Dr Alexander Heazell
alexander.heazell@manchester.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexander Heazell

ORCID ID

Contact details

Maternal and Fetal Health Research Centre
5th Floor (Research)
St Mary's Hospital
Oxford Road
Manchester
M13 9WL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.41

Study information

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

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stillbirth, Perinatal Death

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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

Overall trial start date

01/11/2011

Overall trial end date

01/11/2012

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

120

Participant 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

Recruitment start date

01/11/2011

Recruitment end date

01/11/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

Central Manchester University Hospitals NHS Foundation Trust (UK)

Sponsor details

Research and Innovation Directorate
1st Floor
Postgradute Centre
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.cmft.nhs.uk/

Funders

Funder type

Hospital/treatment centre

Funder name

Manchester Biomedical Research Centre (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Central Manchester University Hospitals NHS Foundation Trust (UK) (ref: R01519)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23590451

Publication citations

  1. Results

    Heazell AE, Bernatavicius G, Roberts SA, Garrod A, Whitworth MK, Johnstone ED, Gillham JC, Lavender T, A randomised controlled trial comparing standard or intensive management of reduced fetal movements after 36 weeks gestation--a feasibility study., BMC Pregnancy Childbirth, 2013, 13, 95, doi: 10.1186/1471-2393-13-95.

Additional files

Editorial Notes