Clinical trial NCT05122390: DIGItal Early Labour. A Digital Application for Coping in Early Phase of Labour.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Keywords: emotional distress
digital application
Lead sponsor: Värmland County Council, Sweden
Sponsor class: OTHER_GOV
Collaborators: name: Karlstad University
name: Uppsala University
First posted: 2021-11-16
Enrollment: 480
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Emotional distress
timeFrame: "Group differences at 1 month after birth"
Secondary outcomes:
measure: Fear of birth
timeFrame: "Assesed during pregnancy week 25 up till week 36 at consent to the study"
measure: Fear of birth in potential future birth
timeFrame: " Group differencies at 1 month after birth"
measure: Sense of coherence
timeFrame: "Assessed during pregnancy week 25 up till week 36 at consent to the study"
measure: Childbirth experience
timeFrame: "Group differencies at 1 month after birth"
measure: Support from birth companion
timeFrame: "Group differencies at1 month after birth"
measure: Childbirth Self-Efficacy Inventory before childbirth
timeFrame: "Assessed during pregnancy week 25 up till week 36 at consent to the study"
measure: Childbirth Self-Efficacy Inventory after childbirth
timeFrame: "Group differencies at1 month after birth"
measure: Activity bracelet FitBit
timeFrame: "At the timepoint were contractions starts during early labour and until the baby is born"
measure: Activity bracelet FitBit
timeFrame: "At the timepoint were contractions startsduring early labour and until the baby is born"
Other outcomes:
measure: Labour outcome from medical record
timeFrame: "At birth"
measure: Medical interventions during labour from medical record
timeFrame: "During labour and birth"
measure: Length of labour phases from medical record
timeFrame: "During labour and birth"
measure: Pain relif methods used from medical record
timeFrame: "During labour and birth"
measure: Apgar Score from medical record
timeFrame: "At birth and during first week after birth"
measure: Neonatal outcome from medical record
timeFrame: "At birth and during first week after birth"
Locations:
city: Karlstad
country: Sweden
facility: Women's department
city: Karlstad
country: Sweden
facility: County of Värmland
Study officials:
affiliation: Region Värmland
name: Karin Ängeby, PhD
role: PRINCIPAL_INVESTIGATOR
References: