Condition category
Pregnancy and Childbirth
Date applied
24/08/2011
Date assigned
12/09/2011
Last edited
07/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

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

Maternal and Fetal Health Research Centre
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