Clinical Trials Logo

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT05122390
Study type Interventional
Source Värmland County Council, Sweden
Contact Karin Ängeby, PhD
Phone +46703579767
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 15, 2022
Completion date June 15, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Completed NCT03284515 - Vaccination In Pregnancy Gene Signature: VIP Signature Study
Recruiting NCT04828382 - Prospective Study of Pregnancy in Women With Cystic Fibrosis
Enrolling by invitation NCT04527926 - STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy N/A
Recruiting NCT04296396 - Opioid Prescription After Cesarean Trial Phase 3
Not yet recruiting NCT04960800 - Effect of a Specific Exercise Program During Pregnancy on Diastasis Recti Abdominis N/A
Not yet recruiting NCT04992104 - Microbiome and Malnutrition in Pregnancy
Completed NCT03188250 - Chama Cha MamaToto: a Pilot Study of Peer Support Groups in Kenya N/A
Recruiting NCT03671109 - Improving Maternal heAlth by Reducing Malaria in African HIV Women Phase 3
Recruiting NCT03855735 - TeamBaby - Safe, Digitally Supported Communication in Obstetrics and Gynecology N/A
Active, not recruiting NCT03679130 - FitMum: Fitness for Good Health of Mother and Child N/A
Completed NCT03687879 - Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum
Recruiting NCT04568044 - Evaluation of Humoral Immunity Following COVID-19 in Pregnancy
Recruiting NCT04572178 - Cash Payment and Counseling During Pregnancy N/A
Recruiting NCT04079959 - Endometrial Leucocytes Around the Time of Embryo Implantation in Women Undergoing in IVF-ET
Active, not recruiting NCT05056142 - Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor N/A
Recruiting NCT04326322 - Methionine Requirements During Healthy Human Pregnancy N/A
Recruiting NCT04725812 - Complement Regulation to Undo Systemic Harm in Preeclampsia Phase 2
Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
Completed NCT04146025 - Nurtured in Nature N/A