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

NCT ID: NCT05122390

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2023-10-01

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.

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.

Conditions

Pregnancy Related

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Contraction Coper

Intervention Type: 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 Plus

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

Group Type: ACTIVE_COMPARATOR

Contraction Coper

Intervention Type: 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 Plus

Intervention Type: 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.

Control

Conventional antenatal care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

°Multiparas.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karlstad University

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: collaborator

Värmland County Council, Sweden

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karin Ängeby, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Värmland

Locations

Women's department

Karlstad, , Sweden

County of Värmland

Karlstad, , Sweden

Countries

Sweden

Other Identifiers

CcVarmland

Identifier Type: -

Identifier Source: org_study_id