Can a test of preterm labour (quantitative fetal fibronectin) help diagnosis and clinical decision making?

Conditions

Preterm labour Pregnancy and Childbirth Preterm labour

Stock SJ, Horne M, Bruijn M, White H, Heggie R, Wotherspoon L, Boyd K, Aucott L, Morris RK, Dorling J, Jackson L, Chandiramani M, David A, Khalil A, Shennan A, Baaren GV, Hodgetts-Morton V, Lavender T, Schuit E, Harper-Clarke S, Mol B, Riley RD, Norman J, Norrie J.

2021-09-016 citations

10.3310/hta25520

Evaluating the use of the QUiPP app and its impact on the management of threatened preterm labour: A cluster randomised trial

Helena Watson, Naomi Carlisle, Paul T. Seed, Jenny Carter, Katy Kuhrt et al. (7 authors)

PLoS Medicine2021-07-0622 citations

10.1371/journal.pmed.1003689

Interventions

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 t

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Delivery rate is measured within 7 days of enrollment in the study	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, Scotland, United Kingdom

Contacts

Public ContactLisa Wotherspoon

lisa.wotherspoon@ed.ac.uk+44 (0)131 242 6753

Outcome results

None listed