Condition category
Pregnancy and Childbirth
Date applied
26/01/2016
Date assigned
02/02/2016
Last edited
16/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Although most labours begin naturally, however around one third of women need help to get started. In these cases, a healthcare professional will often “induce” labour. Although the aim of induction is to achieve a vaginal delivery, it is not always successful and some women end up having a caesarean section (an operation where the child is delivered through a cut in the abdomen). Currently, there are no effective methods to predict which women will not respond favourably to induction of labor or how long this process is likely to take. The aim of this study is to develop techniques to help predict whether induction will result in vaginal delivery or caesarean section.

Who can participate?
Women aged 18 or over with a single baby pregnancy, who have been scheduled for an induction of labour at Medway Maritime Hospital.

What does the study involve?
All women at Medway Maritime Hospital receive a routine clinical assessment in the pre-induction clinic, which involves an ultrasound scan of the baby, digital vaginal examination and a blood test. Participants are also offered an ultrasound scan to measure the length and dilation of the neck of the womb (cervix) and to find out how low the baby’s head is in the pelvis. For those agreeing to take part in the study, a swab of the vagina and another blood sample is taken to be tested in the laboratory for natural indicators (biochemical markers) as well as receiving an ultrasound scan which can help to predict the result of the induction. The amount of women who go into labour following induction are then recorded and compared to the results of prediction from the biochemical markers and ultrasound scan to find out how well the tests are able to predict the results of the induction.

What are the possible benefits and risks of participating?
There are no direct benefits or risks for participants taking part in this study.

Where is the study run from?
Medway Maritime Hospital (UK)

When is the study starting and how long is it expected to run for?
November 2015 to June 2017

Who is funding the study?
Fetal Medicine Foundation (UK)

Who is the main contact?
1. Dr Alexander Frick (public)
2. Mr Ranjit Akolekar (scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr Alexander Frick

ORCID ID

http://orcid.org/0000-0001-8013-3679

Contact details

Fetal Medicine Research Institute
16-20 Windsor walk
London
SE5 8BB
United Kingdom

Type

Scientific

Additional contact

Prof Ranjit Akolekar

ORCID ID

Contact details

Medway Maritime Hospital
Fetal Medicine Unit
Windmill Road
Gillingham
ME7 5NY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2.0

Study information

Scientific title

Prediction Of adverse Pregnancy outcomes following INduction of labour in singleton pregnancies: A single centre observational study

Acronym

POPIN

Study hypothesis

The aim of this study is to assess if a combination of ultrasound findings and biochemical markers from vaginal secretions and maternal blood can better predict vaginal delivery than traditional methods such as the Bishop Score.

Ethics approval

London – Dulwich Research Ethics Committee, 31/03/2016, ref: 16/LO/0367

Study design

Single-centre prospective observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

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

Condition

Pregnancy and childbirth

Intervention

Women attending a pre-induction clinic who are participating in the study will have a vaginal swab taken to test levels of quantitative fetal fibronectin and placental alpha-macroglobulin-1 prior to induction of labour. They will also have a transperineal ultrasound (TPUS) to measure the angle of progression, head-perineum distance and sonographic assessment of cervical dilatation. The results from these assessments will be combined with maternal characteristics to predict mode of delivery.

Patients will then be followed throughout the induction and labour process, with the transperineal ultrasound assessments repeated on a 4 hourly basis to compare the effectiveness of ultrasound with clinical vaginal examination.

Women will be followed until delivery to determine the accuracy of the pre-induction test and intrapartum ultrasound assessments. The total duration of observation will vary from depending on the length of induction and labour, but will typically be 1-3 days. There will be no need for follow up after delivery.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Detection rate and false positive rate for predicting vaginal delivery following induction of labour is measured using a combination of maternal characteristics, ultrasound findings, and biochemical markers from a pre-induction clinic at the time of delivery.

Secondary outcome measures

1. Detection rate for caesarean section for failure to progress is measured using a combination of maternal characteristics, ultrasound findings, and biochemical markers from a pre-induction clinic at the time of delivery
2. Detection rate for caesarean section for fetal distress is measured using a combination of maternal characteristics, ultrasound findings, and biochemical markers from a pre-induction clinic at the time of delivery
3. Detection rate for maternal haemorrhage greater than 1500 ml is measured using a combination of maternal characteristics, ultrasound findings, and biochemical markers from a pre-induction clinic at the time of delivery
4. Detection rate for neonatal intensive care admission is measured using a combination of maternal characteristics, ultrasound findings, and biochemical markers from a pre-induction clinic at the time of delivery
5. Effectiveness of intrapartum ultrasound in predicting vaginal delivery as compared to traditional vaginal examination is determined at the time of delivery

Overall trial start date

01/11/2015

Overall trial end date

01/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Viable singleton pregnancy
3. Aged 18 years or over
4. Cephalic presentation
5. Attending pre-induction of labour clinic
6. Informed written consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1000

Participant exclusion criteria

1. Multiple pregnancies
2. Women with fetal demise
3. Women less than 18 years
4. Women who are unconscious or severely ill, those with learning difficulties, and serious mental illness
5. Malpresentation

Recruitment start date

01/03/2016

Recruitment end date

01/03/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Medway Maritime Hospital
Medway NHS Foundation Trust Windmill Road
Gillingham
ME7 5NY
United Kingdom

Sponsor information

Organisation

Medway NHS Foundation Trust

Sponsor details

Windmill Road
Gillingham
ME7 5NY
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Fetal Medicine Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in leading peer reviewed scientific journals for obstetric ultrasound, such is Ultrasound in Obstetrics & Gynecology.

Intention to publish date

31/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/05/2016: Ethics approval information added.