Condition category
Pregnancy and Childbirth
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
About 11% of all babies born worldwide are preterm (premature) meaning that they are born more than three weeks before their due date. Accurately predicting whether a woman will have a preterm delivery is notoriously challenging. Up to 80% of women who show signs of preterm labour remain pregnant after 7 days. Despite this, many women are given treatments aimed at preventing complications for their babies, should they be premature. This can be very costly and little is known about the effects for mothers and their babies if a preterm delivery does not take place. Fetal fibronectin (fFN) is a “glue-like” protein which attaches the amniotic sac (the fluid sac that contains and protects a fetus) to the lining of the womb. At the end of pregnancy, fFN begins to break down and can be detected in vaginal fluid. By measuring the concentration of fFN, it is possible to predict whether the baby is likely to arrive prematurely (quantitative foetal Fibronectin test). Generally, the result will either be positive (showing the fFN is present and so there is an increased chance of labour) or negative (where it is not present, ruling out the chance of labour). The aim of this study is to find out how accurate the quantitative foetal Fibronectin (qfFN) test is at predicting preterm delivery.

Who can participate?
Women who are showing signs of going into labour prematurely.

What does the study involve?
Women have a vaginal swab taken so that levels of quantitative fetal fibronectin can be measured. This will allow the researchers to predict the chance of the women delivering their babies prematurely over the next seven days. Regular contact is kept with the women in the form of telephone interviews so that the number of women who have had a preterm delivery can be measured.

What are the possible benefits and risks of participating?
There are no direct benefits to women or their babies for participating in this study, although some women gain satisfaction from contributing research studies which will improve future care for women with preterm labour. There are very few risks from participation as qfFN is the most commonly used test for preterm labour, and it is considered to be safe. Knowledge of qfFN results may increase or decrease anxiety levels, and this will be assessed as part of the trial.

Where is the study run from?
Royal Infirmary of Edinburgh (lead centre) and three hospitals in England (UK).

When is the study starting and how long is it expected to run for?
December 2015 to May 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Ms Lisa Wotherspoon (Public)
2. Dr Sarah Stock (Scientific)

Trial website

Contact information



Primary contact

Ms Lisa Wotherspoon


Contact details

University of Edinburgh MRC Centre for Reproductive Health
Queen's Medical Research Institute
47 Little France Crescent
EH16 4TJ
United Kingdom
+44 131 242 6753



Additional contact

Dr Sarah Stock


Contact details

University of Edinburgh MRC Centre for Reproductive Health
Queen's Medical Research Institute
47 Little France Crescent
EH16 4TJ
United Kingdom
+44 131 242 6449

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

QUIDS – Quantitative Fibronectin to help Decision-making in women with Symptoms of Preterm Labour



Study hypothesis

In women with symptoms suggestive of preterm labour, quantitative fetal fibronectin will help rule out preterm labour and aid decision making.

Ethics approval

West of Scotland REC 5, 22/03/2016, ref: 16/WS/0068

Study design

Multi-centre prospective cohort study.

Primary study design


Secondary study design

Cohort study

Trial setting


Trial type


Patient information sheet


Preterm labour


Women with symptoms of preterm labour (22-34 weeks gestational age) who are participating in the study will have a vaginal swab sample taken to test levels of quantitative fetal fibronectin in order to predict the likelihood of preterm delivery within the next 7 days. Women will be followed up until delivery to determine the diagnostic accuracy of the test.

Intervention type



Drug names

Primary outcome measures

Delivery rate is measured within 7 days of enrollment in the study.

Secondary outcome measures

1. Acceptability of the qfFN, measured by telephone interviews in a subset of participants (n=30) at 48 hours following test
2. Anxiety, measured using the State Trait Anxiety Index questionnaire pre and 48 hours post test
3. Cost effectiveness of fFN measured by decison analytical modelling until discharge from hospital
4. Delivery within 48 hours of enrollment in the study
5. Rate of spontaneous preterm delivery before 34 weeks
6. Rate of spontaneous preterm delivery before 37 weeks

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Women with signs and symptoms of preterm labour 24-34 weeks (or earlier gestation if the fetus is considered potentially viable) in whom hospital admission, inter-hospital transfer or treatment (antenatal steroids, tocolysis or magnesium sulphate) is being considered
2. Signs and symptoms may include any or all of the following:
2.1. Back pain
2.2. Abdominal cramping
2.3. Abdominal pain
2.4. Light vaginal bleeding
2.5. Vaginal pressure
2.6. Uterine tightenings or contractions
2.7. Cervical effacement or dilatation.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Women who have moderate or severe vaginal bleeding
2. Women who have cervical dilatation greater or equal to 3cm
3. Women with confirmed rupture of membranes
4. Sexual intercourse, vaginal examination or transvaginal ultrasound in the preceding 24 hours factors can invalidate results and so these women will be initially excluded from the study. They can later be included if still symptomatic after 24 hours, when fFN accuracy will be restored.

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh
51 Little France Crescent
EH16 4TJ
United Kingdom

Trial participating centre

Birmingham Women's Hospital
Mindelsohn Way
B15 2TG
United Kingdom

Trial participating centre

Nottingham University Hospitals
Derby Road
United Kingdom

Trial participating centre

West Middlesex University Hospital
Twickenham Road
United Kingdom

Sponsor information


University of Edinburgh and NHS Lothian ACCORD

Sponsor details

Research & Development Management Suite
The Queen's Medical Research Institute
47 Little France Crescent
EH16 4TJ
United Kingdom
+44 131 242 3336

Sponsor type




Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Results and Publications

Publication and dissemination plan

Intention to publish date


Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.