Condition category
Pregnancy and Childbirth
Date applied
22/10/2018
Date assigned
22/10/2018
Last edited
22/10/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Early labour is the beginning part of a woman’s labour. There is substantial research demonstrating that women with low-risk pregnancies have better birth outcomes if they remain at home during this time. In spite of these advantages, many women do not feel confident to cope with early labour pain at home and seek admission to their place of birth; these women are at greater risk of unnecessary obstetric intervention and poorer birth outcomes. The evidence indicates women are not having their needs met during early labour and research is required in an attempt to address this shortfall in maternity care. The aim of this study is to find out whether an educational website affects women's experiences of early labour.

Who can participate?
Women aged 16 and over who are pregnant for the first time with a single baby with no known complications

What does the study involve?
Participants are randomly allocated to receive usual care plus access to an early labour website (intervention) named “Let’s Talk Early Labour”, or usual care only (control). The website provides evidence-based information about how to cope in early labour, alongside videos of women who have already had babies, talking about their positive experiences of being at home in early labour. Participants’ early labour experiences are assessed using a questionnaire at 7-28 days after giving birth.

What are the possible benefits and risks of participating?
As an educational, web-based resource, and as an enhanced version of the pre-existing maternity care, this intervention is considered to be low risk, posing minimal risks to the participants who receive the intervention. All participants receive the standard maternity care and no care is removed from those who receive the intervention. This is a new intervention and whether the website will have a positive impact on participants as expected, remains unknown. However, the website has been developed with the aim to improve the early labour experiences of those who receive it and so those in the intervention group may benefit from this improved experience.

Where is the study run from?
Princess Anne Hospital (UK)

When is the study starting and how long is it expected to run for?
May 2017 to September 2020

Who is funding the study?
Wessex Partnership Scheme (UK)

Who is the main contact?
Miss Rebecca Cousins
rcousins@bournemouth.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Rebecca Cousins

ORCID ID

http://orcid.org/0000-0002-1414-0114

Contact details

Faculty of Health and Social Sciences
Royal London House
Bournemouth University
Christchurch Road
Bournemouth
BH1 3LT
United Kingdom
+44 (0)7805 772081
rcousins@bournemouth.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

39131

Study information

Scientific title

The Let’s Talk Early Labour (L-TEL) Trial: can an educational website affect nulliparous women's experiences of early labour - a randomised controlled trial

Acronym

L-TEL

Study hypothesis

The study hypothesis is that those participants who receive access to the website antenatally will score higher overall in a self-reported Early Labour Experience Questionnaire (Janssen and Desmaris 2013) when compared to the study group who will receive only routine care.

Ethics approval

NHS Health Research Authority: South Central - Hampshire A Research Ethics Committee, 15/10/2018, ref: 18/SC/0396

Study design

Randomised; Interventional; Design type: Process of Care, Education or Self-Management

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Reproductive Health and Childbirth, Primary sub-specialty: Intrapartum Care; Health Category: Reproductive health and childbirth; Disease/Condition: Delivery

Intervention

The L-TEL Trial will be an open label, single-centre, pragmatic, randomised control trial (RCT), with a mixed method data collection. Participants will be randomised to receive usual care plus access to an early labour website (intervention) named “Let’s Talk Early Labour”, or usual care only (control). This methodology was deemed most appropriate to assess the effectiveness of the intervention in improving first time mothers' experiences of early labour.

The primary outcome is the total score of the Early Labour Experience Questionnaire (ELEQ) (Janssen and Desmaris 2013). This questionnaire will be completed by participants within 4 weeks following childbirth. The target sample size is 100 participants (50 in each trial arm). This is powered by a 10% difference in the total ELEQ score which has been documented as clinically important for a similar scale (Labour and Delivery Satisfaction Index (Lomas et al 1987)) to which the ELEQ was compared for construct validity during its development. It is estimated that 22% of all births in England are artificially induced (RCM 2016) and participants who have their labour induced will not be able to provide an evaluation of their early labour experiences at home. This has been accounted for in the target recruitment number to ensure the primary outcome can still be met.

Posters advertising the trial will be visible around the NHS Trust's maternity department. These posters will also be posted on Trust based social media (i.e. Facebook page). It is anticipated this will publicise the trial to potential participants in the first half of their pregnancy. Women will be able to self-identify themselves by emailing the researcher and a Participant Information Sheet (PIS) can be emailed to eligible women to read. This will be followed up with a phone call from the researcher to answer questions and discuss the trial and ensure informed, voluntary consent. Women who decide to consent will be sent an online consent form prior to randomisation.

In an attempt to ensure women who may not feel confident to self-identify have information about their ongoing trial, community midwives will also screen women for eligibility. At the routine 25 week appointment, women who are assessed by the midwives to be eligible will be advised that The L-TEL Trial is recruiting and will be given some brief information about what the trial entails. There will be a brief online training package for the midwives providing this information to complete. Eligible women will be offered a Participant Information Sheet and asked if they consent to being contacted by the researcher. With permission, contact details (phone number and email) will be collected by their community midwife and provided to the researcher. At least 24 hours later, the researcher will make telephone contact with women to provide an opportunity to discuss the research in more detail, answer any questions about the research and ensure women are able to provide voluntary and informed consent. Those who wish to consent will be emailed an online consent form to complete prior to randomisation. A copy of this consent form will be emailed to the participant and placed in their clinical notes.

Following recruitment and consent, an online, modified version of the Childbirth Self-Efficacy Inventory (CBSEI) (Lowe 1993) will be emailed to participants for completion. Participants will also be asked to provide some baseline characteristics that will later aid data analysis (year of birth, marital status, ethnicity, education level, and postcode). These baseline characteristics are important as they may have an impact on women’s early labour experiences. Provision of these details will be optional.

Following simple computer randomisation, the researcher will email and text the participant to inform them of their trial arm and request a response from the participant to ensure they have received this information.

Those in the intervention group will receive a link via text and email to the “Let’s Talk Early Labour” website and will be able to freely use this throughout the remainder of their pregnancy. The intervention group will continue to receive usual antenatal care. The control group will not receive the website link and will continue to receive usual antenatal care as scheduled.

At 7-14 days postnatally, both trial arms will receive an online, modified version of the Early Labour Experience Questionnaire (Janssen and Desmaris 2013) to complete. Questions will be added to the end to measure adherence to the intervention, gauge how the intervention group used the website and what was liked best and least about the website.

The researcher will collect some other maternal and neonatal clinical outcomes (see secondary outcomes section for details) by retrospectively reviewing the computerised, centralised hospital system where this data is already routinely collected. This data will be managed anonymously on a data management form. All data will be kept secure on a university password protected computer.

Research participants will be enrolled on the study for an estimated 21 weeks (≈ 5 months) (the end 17 weeks of their pregnancy and up to 4 weeks postnatally). The trial will end when the last ELEQ response is returned.

Based on the number of women booked to birth at the NHS Trust, it is anticipated the L-TEL trial will run for 14 months.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Women’s affective experience as determined by the total score of a pre-validated Early Labour Experience Questionnaire (ELEQ) (Janssen and Desmaris 2013) (modified for online use with the author's permission), measured at 7-28 days postnatal

Secondary outcome measures

A number of secondary, maternal and neonatal clinical outcomes will also be retrospectively collected, by the researcher, from the hospital’s centralised computer system during the 6 week postnatal period following a participant's birth. These outcomes will be:
1. Labour phase (as defined by NICE 2014 guidelines) on admission
2. Place of birth
3. Birth mode (i.e. spontaneous vaginal birth, instrumental assisted birth or operative caesarean section birth)
4. Analgesia use
5. Augmentation of labour (artificial rupture of membranes, intrapartum oxytocin infusion use)
6. Neonatal Apgar scores as assessed at 1 minute and 5 minutes of age
7. Neonatal resuscitation required
8. Breastfeeding at discharge from place of birth

Overall trial start date

18/05/2017

Overall trial end date

21/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Pregnant with a live, healthy, single foetus without known complications
2. Nulliparous (no previous pregnancy >24 weeks gestation)
3. At least 16 years of age at the point of consent
4. Suitable as per Trust guidelines for a spontaneous, vaginal birth at a midwifery-led unit
5. Able to speak and read English for the purpose of informed consent
6. Not requiring antenatal care from a specialist, case-loading midwifery team (a team specifically available for women with complex social needs)
7. Able to access the internet, either on WiFi or on mobile data without unacceptable costs from doing so

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

1. Pregnancy with complications (medical, maternal or fetal) that requires birth at the obstetric led unit
2. Multiparous (any previous pregnancy > 24 weeks gestation)
3. Planning for induction or caesarean section birth
4. Unable to speak or read English for informed consent
5. Requiring specialist care from a case-loading midwifery team for complex social needs
6. Unable to access the internet without inappropriate associated costs

Recruitment start date

22/10/2018

Recruitment end date

22/09/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Princess Anne Hospital
Coxford Road
Southampton
SO16 5YA
United Kingdom

Sponsor information

Organisation

Bournemouth University

Sponsor details

c/o Mrs Julie Northam
4th Floor Melbury House
1-3 Oxford Road
Bournemouth
BH8 8ES
United Kingdom
+44 (0)1202962381
jnortham@bournemouth.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Wessex Partnership Scheme

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal with intent to publish by the end of 2020.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/10/2018: The participant information sheet has been uploaded.