DIGItal Early Labour. A Digital Application for Coping in Early Phase of Labour.

NCT05122390 | Completed

• 1 other identifier: CcVarmland
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pregnancy Related

Keywords

emotional distress; digital application

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Fear of birth

  "Assesed during pregnancy week 25 up till week 36 at consent to the study"

• Fear of birth in potential future birth

  " Group differencies at 1 month after birth"

• Sense of coherence

  "Assessed during pregnancy week 25 up till week 36 at consent to the study"

• Childbirth experience

  "Group differencies at 1 month after birth"

• Support from birth companion

  "Group differencies at1 month after birth"

Other Outcomes (6)

• Labour outcome from medical record

  "At birth"

• Medical interventions during labour from medical record

  "During labour and birth"

• Length of labour phases from medical record

  "During labour and birth"

Study Arms (3)

Contraction Coper

EXPERIMENTAL

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

Contraction Coper Plus

ACTIVE COMPARATOR

The digital application Contraction Coper with additionally support from a midwife in two different occasions during pregnancy.

Other: Contraction Coper; Other: Contraction Coper Plus

Control

NO INTERVENTION

Conventional antenatal care.

Interventions

Contraction Coper OTHER

Digital application built on the Birth without fear method, based on four different tools to be used during labour. Breathing, relaxation, voice and mind.

Contraction Coper; Contraction Coper Plus

Contraction Coper Plus OTHER

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.

Contraction Coper Plus

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant persons
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• °Multiparas.

Sponsors & Collaborators

• Värmland County Council, Sweden: lead
• Karlstad University: collaborator
• Uppsala University: collaborator

Study Sites (2)

Women's department

Karlstad, 65340, Sweden

Location

County of Värmland

Karlstad, Sweden

Location

Study Officials

• Karin Ängeby, PhD

  Region Värmland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The experimental group is divided into two groups, one group that gets access to the application Contraction Coper only and one group gets Contraction Coper Plus, both the application and additional support of the midwife through blended care. The third group is standard care only.

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: November 16, 2021
• Study Start: October 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: October 1, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)