Pregnancy RelatedDIGI-ELNCT05122390
DIGItal Early Labour. A Digital Application for Coping in Early Phase of Labour.
A study testing Contraction Coper and Contraction Coper Plus in people with Pregnancy Related, run by Värmland County Council, Sweden at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Contraction Coper and Contraction Coper Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 2 sitesSweden
- Study dates
- 15 Oct 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First time mothers
- From pregnancy week 25.
- Swedish or English spoken.
- Having a Smartphone, Android or Apple application.
Who cannot join
- °Multiparas.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Contraction Coper, Contraction Coper Plus
- Keywords
- emotional distress, digital application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraction CoperOther
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 PlusOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Contraction Coper; Other: Contraction Coper Plus |
| Control | No intervention | Conventional antenatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "Group differences at 1 month after birth"
Secondary outcomes (9)
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.
Measured: "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.
Measured: " 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.
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "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.
Measured: "Group differencies at1 month after birth"
Activity bracelet FitBit
Heartrate is measured using activity bracelet. A higher heartrate indicates more pain and distress
Measured: "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
Measured: "At the timepoint were contractions startsduring early labour and until the baby is born"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start15 Oct 2022
- Primary completion15 Jul 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Värmland County Council, Sweden
- Sponsor type
- Other government
- Collaborators
- Karlstad University, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Karin Ängeby, PhD, Principal investigator, Region Värmland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122390
- Sponsor's protocol ID
- CcVarmland
- Acronym
- DIGI-EL
- Status last verified
- Oct 2023
- First submitted
- 23 Sep 2021
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05122390
- Acronym / sponsor ID
- DIGI-EL / CcVarmland
- Conditions
- Pregnancy Related
- Keywords
- emotional distress, digital application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Värmland County Council, SwedenOther government
- Collaborators
- Karlstad University, Uppsala University
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Contraction Coper | Experimental | Other: Contraction CoperThe 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). |
| Contraction Coper Plus | Active comparator | Other: Contraction Coper, Other: Contraction Coper PlusThe digital application Contraction Coper with additionally support from a midwife in two different occasions during pregnancy. |
| Control | No intervention | –Conventional antenatal care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First time mothers
- From pregnancy week 25.
- Swedish or English spoken.
- Having a Smartphone, Android or Apple application.
Key exclusion criteria (1 listed)
- °Multiparas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contraction CoperDigital 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, Contraction Coper Plus |
| Contraction Coper PlusDigital 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. | Other | Contraction Coper Plus |
Primary outcome
Emotional distress
Time frame: "Group differences at 1 month after birth"
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.
9 secondary outcomes
Fear of birth
Time frame: "Assesed during pregnancy week 25 up till week 36 at consent to the study"
Fear of birth in potential future birth
Time frame: " Group differencies at 1 month after birth"
Sense of coherence
Time frame: "Assessed during pregnancy week 25 up till week 36 at consent to the study"
Childbirth experience
Time frame: "Group differencies at 1 month after birth"
Support from birth companion
Time frame: "Group differencies at1 month after birth"
Childbirth Self-Efficacy Inventory before childbirth
Time frame: "Assessed during pregnancy week 25 up till week 36 at consent to the study"
Childbirth Self-Efficacy Inventory after childbirth
Time frame: "Group differencies at1 month after birth"
Activity bracelet FitBit
Time frame: "At the timepoint were contractions starts during early labour and until the baby is born"
Activity bracelet FitBit
Time frame: "At the timepoint were contractions startsduring early labour and until the baby is born"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Ängeby, PhD principal investigator
Region Värmland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contraction Coper and Contraction Coper Plus in people with Pregnancy Related, run by Värmland County Council, Sweden at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional distress (time frame: "Group differences at 1 month after birth"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.