The Let's Talk Early Labour (L-TEL) Trial

Not Applicable

Completed

• Conditions: abour; Pregnancy and Childbirth

• Registration Number: ISRCTN69770712
• Lead Sponsor: Bournemouth University

Brief Summary

2023 Results article in https://doi.org/10.1016/j.wombi.2023.07.132 (added 14/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-22
• Study Completion: 2020-09-21
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 140

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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:<br>1. Labour phase (as defined by NICE 2014 guidelines) on admission<br>2. Place of birth<br>3. Birth mode (i.e. spontaneous vaginal birth, instrumental assisted birth or operative caesarean section birth)<br>4. Analgesia use<br>5. Augmentation of labour (artificial rupture of membranes, intrapartum oxytocin infusion use)<br>6. Neonatal Apgar scores as assessed at 1 minute and 5 minutes of age<br>7. Neonatal resuscitation required<br>8. Breastfeeding at discharge from place of birth