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

V

Värmland County Council, Sweden

Status

Completed

Conditions

Pregnancy Related

Treatments

Other: Contraction Coper Plus
Other: Contraction Coper

Study type

Interventional

Funder types

Other

Identifiers

NCT05122390
CcVarmland

Details and patient eligibility

About

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.

Full 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.

Enrollment

480 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

°Multiparas.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

480 participants in 3 patient groups

Contraction Coper
Experimental group
Description:
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).
Treatment:
Other: Contraction Coper
Contraction Coper Plus
Active Comparator group
Description:
The digital application Contraction Coper with additionally support from a midwife in two different occasions during pregnancy.
Treatment:
Other: Contraction Coper
Other: Contraction Coper Plus
Control
No Intervention group
Description:
Conventional antenatal care.

Trial contacts and locations

2

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Central trial contact

Anna Nordin, PhD; Karin Ängeby, PhD

Data sourced from clinicaltrials.gov

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