WAHT-OBS-070

It is the responsibility of every individual to check that this is the latest version/copy of this document.

ACTIM PARTUS TEST IN THE PREDICTION OF

PRETERM LABOUR

This guidance does not override the individual responsibility of health professionals to make
appropriate decision according to the circumstances of the individual patient in consultation with
the patient and/or carer. Health care professionals must be prepared to justify any deviation
from this guidance.

INTRODUCTION

Actim Partus test is a visually interpreted, qualitative immunochromatographic dipstick test for
detecting the presence of phosphorylated IGFBP-1 (insulin-like growth factor binding protein-1)
in cervical secretions. The presence of phosphorylated IGFBP-1 during weeks 24-34 of
pregnancy, along with symptoms of labour, suggests the possibility of a preterm labour.

THIS GUIDELINE IS FOR USE BY THE FOLLOWING STAFF GROUPS:

Medical and midwifery staff competent to perform test.

To be used in conjunction with preterm labour guideline

WAHT-OBS-009 Preterm prelabour rupture of membranes (PPROM)
WAHT-OBS-007 Spontaneous preterm labour
IH-OBS-001 SWMNN Preterm labour guideline

Lead Clinician(s)
Miss R Duckett Consultant Obstetrician
Miss R Imtiaz Consultant Obstetrician
Mrs J A Barratt Clinical Midwife Specialist

Guideline approved by the Obstetrics Clinical Governance 19th July 2013

Group:

Extension approved by Trust Management Committee on: 22nd July 2015

This guideline should not be used after end of: 19th July 2016

Actim Partus test in prediction of preterm labour

WAHT-OBS-070 Page 1 of 10 Version 6.1
WAHT-OBS-070
It is the responsibility of every individual to check that this is the latest version/copy of this document.

Key amendments to this guideline

Date Amendment By:
06.09.05 Approved by Clinical Effectiveness
Committee
02.11.05 Point of Care Testing approved by Dr A Munro
10.01.08 Reviewed by Clinical lead and approved by Obstetrics Guideline
group
05.01.10 Guideline extended for a further period with no
amendments made
27.04.10 Minor amendments to wording Rachel Duckett
03.08.12 Extended by lead for a further 3 months to allow for Rachel Duckett
agreement of further changes.
31.08.12 If Fetal Fibronectin is negative then the patient should only Rachel Duckett
be considered for transfer to another hospital after review
by the Obstetric Consultant. The decision for transfer
should then be a consultant to consultant referral with
clear documentation as to the indications for transfer.
28.05.13 Change in practice to Actim Partus test from Fetal Judi Barratt
Fibronectin
07.08.15 Document extended for 12 months as per TMC paper TMC
approved on 22nd July 2015

Actim Partus test in prediction of preterm labour

WAHT-OBS-070 Page 2 of 10 Version 6.1
WAHT-OBS-070
It is the responsibility of every individual to check that this is the latest version/copy of this document.

ACTIM PARTUS TEST IN

PREDICTION OF PRETERM LABOUR
Introduction

Actim Partus test is a visually interpreted, qualitative immunochromatographic dipstick test for
detecting the presence of phosphorylated IGFBP-1 (insulin-like growth factor binding protein-1)
in cervical secretions.
The presence of phosphorylated IGFBP-1 during weeks 24-34 of pregnancy, along with
symptoms of labour, suggests the possibility of a preterm labour.

The appropriate use of Actim Partus test, should reduce not only the need for tocolysis,
but also reduce the number of unnecessary courses of steroids currently used. It will
also be beneficial in reducing unnecessary transfers between units.

Patients Covered

Patients eligible for Actim Partus

1. Women are between 24+0 weeks and 34+0 /35+6 weeks’ gestation.
2. Women are tightening or contracting and there is no sign of cervical dilatation on speculum.
3. There is no evidence of ruptured membranes.
4. There has been no moderate or heavy bleeding or suspected placental abruption or
placenta praevia.
5. No fetal compromise or demise
6. Singleton or twin pregnancy.

Patients NOT eligible for Actim Partus

Women presenting with signs and symptoms of threatened preterm labour between 24+0 –35+6
weeks with:

1. Ruptured membranes.
2. Cervical dilatation more than or equal to 1.5 cms or less than or equal to 1 cm long.
3. Moderate or gross vaginal bleeding.
4. Co-existing medical disorder such as severe pre eclampsia.
5. Gestational age <24+0 weeks or >35+6 weeks.

The test is kept in the clean utility room on central / delivery suite.

Specimen collection

Step 1: Test should ideally be performed prior to a digital examination. Insert a speculum and
visualise the cervical os. Take the cervical secretion sample by the holding the sterile polyester
swab at the Cervical Os for 10-15 seconds. This allows the swab to absorb a sufficient amount
of specimen. If indicated also take HVS and endocervical swabs.

Step 2: Open the Specimen Extraction solution tube and place the polyester swab in the
extraction solution tube and swirl around vigorously for approx. 10 seconds. Press the swab
Actim Partus test in prediction of preterm labour
WAHT-OBS-070 Page 3 of 10 Version 6.1
WAHT-OBS-070
It is the responsibility of every individual to check that this is the latest version/copy of this document.

against the wall of the Specimen Extraction Solution tube to remove any remaining liquid from
the swab. Discard the swab.

Step 3: Open the foil pouch containing the dipstick by tearing. Do not touch the yellow dip area
at the lower part of the dipstick. Patient identification marks may be written on the upper purple
part of the dipstick. The dipstick must be used ASAP after its removal from the foil pouch.

Step 4: Place the yellow dip area of the dipstick into the extracted sample and hold it there
until you see the liquid front reach the result area. Remove the dipstick from the solution and
place it in a horizontal position.

Step 5: A negative result (control line only) should be read at 5 minutes. The results should
not be interpreted after this time.

Step 6: A positive test result can be interpreted as soon as two blue lines - a control line and a
test line - appear in the result area. If, after five minutes, only the control line has appeared,
the test result is negative. Should no control line appear, the test should be discarded and a
new test performed.

Negative Result
 A negative result has a negative predictive value of 100% for birth within 48 hours, and
92% for birth within 7 – 14 days.
 If the result is negative the patient should be discharged home unless other obstetric
indications require admission.
 All women with a negative test will be given education on the signs and symptoms of
preterm labour and reassured that they can come back at any time.
 NB A negative test is not helpful if there is cervical dilatation present. The patient
should then be treated as being in preterm labour. Clinical judgement must
always be a part of the assessment – in the presence of a negative test where
there is still a high index of suspicion, please discuss the case with the ST 6 -7/
Consultant on call.

Positive Result
 Once a positive test has been confirmed on a woman who has signs and symptoms of
preterm labour the management will be in accordance to the preterm labour guidelines.
WHAT-OBS-007
 Positive test patient should have steroids administered.
 The use of tocolysis should be considered in line with the preterm labour guideline.
 Neonatal Intensive Care will be notified of admission. If there are no cots available it
may be necessary to arrange an intra-uterine transfer, this should always involve
discussion with the Consultant Obstetrician on call.

If the woman has not delivered within 7 days, a plan of care will be decided by the obstetric
consultant/obstetric team. A further Actim Partus test may be indicated.

Management of Actim Partus test result

If Actim Partus test negative:

 Reassure the patient.
 Prescribe Oral analgesia (if needed).
 Discharge home 2 hours after contractions/pain settles.
 If Actim Partus is negative then the patient should only be considered for transfer to
another hospital after review by the Obstetric Consultant. The decision for transfer

Actim Partus test in prediction of preterm labour

WAHT-OBS-070 Page 4 of 10 Version 6.1
WAHT-OBS-070
It is the responsibility of every individual to check that this is the latest version/copy of this document.

should then be a consultant to consultant referral with clear documentation as to the

indications for transfer.

If Actim Partus test positive:

 Admit for observation.
 Intravenous access.
 Take blood for Group and Save. FBC.
 Send MSU for culture and sensitivity.
 Prescribe Steroids if <34 completed weeks. See WAHT-OBS-009 PPROM
 Prescribe Oral analgesia if required.
 ? Tocolysis - refer to Atosiban guideline D12 WAHT-OBS-020
 Arrange transfer to hospital with neonatal unit (Worcestershire Royal Hospital or other)
as per guideline.
 Request pediatrician to speak to mother

Actim Partus test in prediction of preterm labour

WAHT-OBS-070 Page 5 of 10 Version 6.1
WAHT-OBS-070
It is the responsibility of every individual to check that this is the latest version/copy of this document.

APPENDIX 1

Actim Partus test in prediction of preterm labour

WAHT-OBS-070 Page 6 of 10 Version 6.1
WAHT-OBS-070
It is the responsibility of every individual to check that this is the latest version/copy of this document.

MONITORING TOOL
How will monitoring be carried out? Audit of forms within medical records
Who will monitor compliance with the guideline? Obstetric Governance Committee

STANDARDS:
Item % Exceptions
All women presenting in possible preterm labour who are eligible will 100%
have Actim Partus testing to determine management.

REFERENCES

1. Erdemoglu and Mungan T. Significance of detecting insulin-like growth factor binding

protein-1 in cervicovaginal secretions: comparison with nitrazine test and amniotic fluid
volume assessment. Acta Obstet Gynecol Scand (2004) 83:622-626.

2. Kubota T and Takeuchi H. Evaluation of insulin-like growth factor binding protein-1 as

a diagnostic tool for rupture of the membranes.J Obstet Gynecol Res (1998) 24:411-
417.

3. Rutanen E-M et al. Evaluation of a rapid strip test for insulin-like growth factor binding
protein-1 in the diagnosis of ruptured fetal membranes. Clin Chim Acta (1996) 253:91-
101.

4. Rutanen E-M, Pekonen F, Kärkkäinen T. Measurement of insulin-like growth factor

binding protein-1 in cervical/vaginal secretions: comparisonwith the ROM-check
Membrane Immunoassay in the diagnosis of ruptured fetal membranes

Actim Partus test in prediction of preterm labour

WAHT-OBS-070 Page 7 of 10 Version 6.1
WAHT-OBS-070
It is the responsibility of every individual to check that this is the latest version/copy of this document.

CONTRIBUTION LIST
Key individuals involved in developing the document
Name Designation
Miss R Imtiaz Consultant Obstetrician
Miss R Duckett Consultant Obstetrician
Mrs Judi Barratt Clinical Midwife Specialist
Circulated to the following individuals for comments
Mr S Agwu Consultant Obstetrician/Gynaecologist
Mrs P Arya Consultant Obstetrician/Gynaecologist
Mrs A Blackwell Consultant Obstetrician/Gynaecologist
Mrs S Ghosh Consultant Obstetrician/Gynaecologist
Mr J Hughes Consultant Obstetrician/Gynaecology
Miss M Pathak Consultant Obstetrician/Gynaecologist
Mrs J Shahid Consultant Obstetrician/Gynaecologist
Miss D Sinha Consultant Obstetrician/Gynaecologist
Miss L Thirumalaikumar Consultant Obstetrician/Gynaecologist
Mr A Thomson Clinical Director - Consultant Obstetrician/Gynaecologist
Mr J Uhiara Consultant Obstetrician/Gynaecologist
Mr J F Watts Consultant Obstetrician-Gynaecologist
Rosemary Fletcher Clinical Pharmacist
Patti Paine Head of Midwifery
Karen Kokoska Maternity Services Risk Manager
Rachel Carter Matron IP WRH
Margaret Stewart Matron OP-Community
Alison Talbot Matron IP Alexandra Hospital
Fiona Pagan Delivery Suite Manager, Alexandra Hospital
Jossette Jones / Sally Talbot Delivery Suite Deputy Managers, Alexandra Hospital
Pamela Jones Delivery Suite Manager, WRH
User representatives LW Forum
Midwife representatives from clinical areas (for consultation with their peers)
J A Barratt Clinical Midwife Specialist
M Byrne Midwife, Alexandra Hospital
H Doherty/J McGivney Community Midwife, Bromsgrove-Redditch Team
J S Farmer Midwife, Antenatal Clinic, WRH
C Parry Community Midwife, Evesham Team
J Martin Midwife, Alexandra Hospital
T Meredy Midwife, Antenatal Clinic, Alexandra Hospital
R Rees Audit & Training Midwife/WRH representative
G Robinson Community Midwife, Worcester Team
H Walker Community Midwife, Kidderminster
V Tristram Midwife, Kidderminster Hospital/Supervisor of Midwives
J Voyce Community Midwife, Malvern Team
B Wilkes Midwife, Alexandra Hospital
R Williams Midwife, WRH
Circulated to the following CD’s/Heads of dept for comments from their
directorates/depts
Dr A Short/Dr A Gallagher Consultant Paediatrician
Circulated to the chair of the following committee’s / groups for comments
Alison Smith Medicines Safety Committee
Mr A Munro Point of Care Testing

Actim Partus test in prediction of preterm labour

WAHT-OBS-070 Page 8 of 10 Version 6.1
 WAHT-OBS-070
It is the responsibility of every individual to check that this is the latest version/copy of this document.

Supporting Document 1 - Equality Impact Assessment Tool

To be completed by the key document author and attached to key document when submitted
to the appropriate committee for consideration and approval.

Yes/No Comments
1. Does the policy/guidance affect one group
less or more favourably than another on the
basis of:

Race
Ethnic origins (including gypsies and
travellers)
Nationality
Gender Yes Pregnant women

Culture
Religion or belief
Sexual orientation including lesbian,
gay and bisexual people
Age
2. Is there any evidence that some groups are No
affected differently?
3. If you have identified potential No
discrimination, are any exceptions valid,
legal and/or justifiable?
4. Is the impact of the policy/guidance likely to No
be negative?
5. If so can the impact be avoided? No
6. What alternatives are there to achieving the No
policy/guidance without the impact?
7. Can we reduce the impact by taking No
different action?

If you have identified a potential discriminatory impact of this key document, please refer it to Human
Resources, together with any suggestions as to the action required to avoid/reduce this impact.

For advice in respect of answering the above questions, please contact Human Resources

Actim Partus test in prediction of preterm labour

WAHT-OBS-070 Page 9 of 10 Version 6.1
 WAHT-OBS-070
It is the responsibility of every individual to check that this is the latest version/copy of this document.

Supporting Document 2 – Financial Impact Assessment

To be completed by the key document author and attached to key document when submitted to the
appropriate committee for consideration and approval.

Yes/No
Title of document:

1. Does the implementation of this document require any additional No

Capital resources

2. Does the implementation of this document require additional No

revenue

3. Does the implementation of this document require additional No

manpower

4. Does the implementation of this document release any No

manpower costs through a change in practice

5. Are there additional staff training costs associated with No

implementing this document which cannot be delivered through
current training programmes or allocated training times for staff

Other comments:

If the response to any of the above is yes, please complete a business case and which is signed by your
Finance Manager and Directorate Manager for consideration by the Accountable Director before
progressing to the relevant committee for approval

Actim Partus test in prediction of preterm labour

WAHT-OBS-070 Page 10 of 10 Version 6.1