Prediction of adverse pregnancy outcomes following induction of labour

ISRCTN ISRCTN10984408
DOI https://doi.org/10.1186/ISRCTN10984408
Secondary identifying numbers 2.0
Submission date
26/01/2016
Registration date
02/02/2016
Last edited
16/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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)

Contact information

Dr Alexander Frick
Public

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

ORCiD logoORCID ID 0000-0001-8013-3679
Prof Ranjit Akolekar
Scientific

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

Study information

Study designSingle-centre prospective observational cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titlePrediction Of adverse Pregnancy outcomes following INduction of labour in singleton pregnancies: A single centre observational study
Study acronymPOPIN
Study objectivesThe 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(s)London – Dulwich Research Ethics Committee, 31/03/2016, ref: 16/LO/0367
Health condition(s) or problem(s) studiedPregnancy and childbirth
InterventionWomen 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 typeOther
Primary outcome measureDetection 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 measures1. 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 study start date01/11/2015
Completion date01/10/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants1000
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/03/2016
Date of final enrolment01/03/2017

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

Medway NHS Foundation Trust
Hospital/treatment centre

Windmill Road
Gillingham
ME7 5NY
England
United Kingdom

ROR logo "ROR" https://ror.org/01apxt611

Funders

Funder type

Charity

Fetal Medicine Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
FMF
Location
United Kingdom

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in leading peer reviewed scientific journals for obstetric ultrasound, such is Ultrasound in Obstetrics & Gynecology.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

12/05/2016: Ethics approval information added.