DIGItal Early Labour. A Digital Application for Coping in Early Phase of Labour. (DIGI-EL)

Can a Mobile Application, Contraction Coper, Better Prepare Women in Early Labour and Reduce Emotional Distress for Nulliparous Women? A Randomised Control Trial (the Digi-EL Trial) in a Swedish Sample

All first-time mothers in Sweden are offered parental support, but local conditions mean that not everyone gets the opportunity to take part in this. Studies show that there is a lack of evidence-based guidelines for the design of parental support in maternal health care. Early labour or latent phase of labour is the part of childbirth were women often feel insecure, in stress and left out from care. First-time mothers who have no experience of one labour before are particularly vulnerable. Many women today use digital applications during pregnancy and in connection with childbirth. There are several digital applications that will help the woman by guiding her and her partner in different decisions about labour, but it is necessary to offer evidence-based, credible electronic and digital solutions for expectant parents. A meta-synthesis from 2018 showed that women use the internet often and the information they receive there has a great influence on their different choices in connection with childbirth. Volume, accessibility, and convenience about digital solutions play a crucial role for women and partners. The digital application Contraction Coper is designed and tested by the company Birth By Heart © in order to facilitate in early labour for the pregnant woman and her partner. The overall purpose of the project is to evaluate whether the application Contraction Coper can contribute to reduced anxiety and stress during pregnancy and childbirth and whether an additional support from a midwife can increase the application use and satisfaction of women when using the application.

A randomized controlled trial is planned where first-time mothers after pregnancy week 25 are invited to participation via social platforms. Participating first-time mothers are randomly assigned to one of three groups; experiment group one, which gets access to the application Contraction Coper, experiment group two Contraction Coper Plus which gets access to both the application and support of midwives, so-called "blended" care, or three, the control group offered customary maternity care only.

Data collection is conducted using questionnaires, mobile application and activity bracelet.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Contraction Coper; Other: Contraction Coper Plus

Detailed Description

The primary outcome is emotional stress in early labour measured with the dimension "Emotional Distress" in the questionnaire Early Labour Experience Questionnaire (ELEQ) Secondary outcomes are Fear of Birth Scale(FOBS), Childbirth Experience Questionnaire (CEQ), used pain relief methods during labour and birth, mode of birth, amount of time used in the application as well as heart rate, sleep and activity for the experimental groups that had activity bracelets in addition.

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Karlstad, Sweden, 65340
    • Women's department
  • Karlstad, Sweden
    • County of Värmland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• First time mothers
• From pregnancy week 25.
• Swedish or English spoken.
• Having a Smartphone, Android or Apple application.

Exclusion Criteria:

°Multiparas.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contraction Coper; The digital application Contraction Coper is provided from pregnancy week 25. The application contains two different modules. One is an informational module about the method (about 60 minutes), the other is a contraction module to be used in early labour (in total 6 hours).	Other: Contraction Coper; Digital application built on the Birth without fear method, based on four different tools to be used during labour. Breathing, relaxation, voice and mind.
Active Comparator: Contraction Coper Plus; The digital application Contraction Coper with additionally support from a midwife in two different occasions during pregnancy.	Other: Contraction Coper; Digital application built on the Birth without fear method, based on four different tools to be used during labour. Breathing, relaxation, voice and mind.; Other: Contraction Coper Plus; Digital application built on the Birth without fear method, based on four different tools to be used during labour. Breathing, relaxation, voice and mind. Clinical guidance from a midwife during two different occasions is added to the group.
No Intervention: Control; Conventional antenatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotional distress	The subscale Emotional distress from Early Labour Experience Questionnaire (ELEQ) will be used for measure. Emotional distress scale is assessed on a five point Likert scale 1-5. Minimum score 6 and maximum score is 30. A higher score represents more distress during early labour.	"Group differences at 1 month after birth"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of birth	Fear of forthcoming birth will be measured with Birth scale (FOBS) by a question 'How do you feel right now about the approaching birth?' by placing a mark on two different 10-cm lines, by using the anchors; (a)'calm' and 'worried' and (b) 'no fear' and 'strong fear' creating an average of minimum score is 0 and maximum score 100 with high scores indicating higher levels of childbirth fear. Cut off point is considered at 60.	"Assesed during pregnancy week 25 up till week 36 at consent to the study"
Fear of birth in potential future birth	Fear of Birth scale (FOBS) will be used and asked by a question 'How do you feel right now about a potential future birth?' by placing a mark on two different 10-cm lines, by using the anchors; (a)'calm' and 'worried' and (b) 'no fear' and 'strong fear' creating an average of minimum score is 0 and maximum score 100 with high scores indicating higher levels of childbirth fear. Cut off point is considered at 60. Pairwise analyse with score before birth.	" Group differencies at 1 month after birth"
Sense of coherence	Sense of Coherence will be measured with SOC-13 (short version). Each question is answered between 1-7. The summed score ranges between 13 and 91. Score is categorized into low(<60), moderate (61-75) and high (>76) SOC.	"Assessed during pregnancy week 25 up till week 36 at consent to the study"
Childbirth experience	Childbirth Experience Questionnaire(CEQ) will be used. The questionnaire contains four different dimensions. The items (n=22) are measured on a four point Likert scale. Minimum is 22 and maximum 88. A higher value represents a more positive chidbirth experience.	"Group differencies at 1 month after birth"
Support from birth companion	The Birth Companion Support Questionnaire (BCSQ) will be used for measuring the support the woman experiences from her partner during labour and birth and contains two different dimensions. 12 items are answered on a 4 point Likert scale. Minimum is 12 and maximum is 48. A higher score represents a more positive attitude about recieved support.	"Group differencies at1 month after birth"
Childbirth Self-Efficacy Inventory before childbirth	The Swedish version of Child Birth Self-efficacy Inventory, (CBSEI) will be used. The questionnaire measuring self-efficacy on both outcome expectancies, i.e. 'what behavior do you think would be useful during labour' as well as self-efficacy expectancies, i.e.' how do you think you will be able to conduct yourselves during labour'. The 15 questions will be asked on ten point Likert scale. ranging from 1 to 10; higher scores indicate a higher degree of childbirth self-efficacy. Minimumscore is 15 and maximum scores are 150 on both scales.	"Assessed during pregnancy week 25 up till week 36 at consent to the study"
Childbirth Self-Efficacy Inventory after childbirth	The Swedish version of Child Birth Self-efficacy Inventory (CBSEI) with the assessment of self-efficacy after childbirth. 'How did you conduct yourselves during labour'. The 15 questions will be asked on ten point Likert scale. ranging from 1 to 10; higher scores indicate a higher degree of childbirth self-efficacy during childbirth. Minimumscore is 15 and maximum scores are 150. Pairwise analysis with score before birth for analysis.	"Group differencies at1 month after birth"
Activity bracelet FitBit	Heartrate is measured using activity bracelet. A higher heartrate indicates more pain and distress	"At the timepoint were contractions starts during early labour and until the baby is born"
Activity bracelet FitBit	Sleep pattern is measured using activity bracelet. A shorter and interrupted sleep indicates more pain and distress	"At the timepoint were contractions startsduring early labour and until the baby is born"

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labour outcome from medical record	Mode of birth; vaginal, vaccuum extraction, cesarean section	"At birth"
Medical interventions during labour from medical record	Amniotomy, oxytocin augmentation yes/no	"During labour and birth"
Length of labour phases from medical record	Length of latent phase, length of active phase, length of pushing phase, measured in minutes and hours	"During labour and birth"
Pain relif methods used from medical record	Nitrus oxide, Epidural, Spinal, non-medical pain relief yes/no	"During labour and birth"
Apgar Score from medical record	Apgar Score ranging from 1-10, at 1 and 5 and 10 minutes after childbirth. Minimum 0-0-0 and maximum 10-10-10.	"At birth and during first week after birth"
Neonatal outcome from medical record	Neonatal care at neonatal intensive unit within one week after childbirth, yes/no	"At birth and during first week after birth"

Collaborators and Investigators

• Sponsor: Värmland County Council, Sweden
• Collaborators: Uppsala University; Karlstad University
• Investigators: Principal Investigator: Karin Ängeby, PhD, Region Värmland

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: November 15, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: emotional distress; digital application
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature
• Other Study ID Numbers: CcVarmland

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No