A-BIRTHPERFORM Versus Conventional Partogram in the Improvement of Birth Results
NCT04009993 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 969
Last updated 2019-07-08
Summary
Midwives and Obstetricians when assisting women during labour do not follow the clinical guidelines on labour process care,in many cases oxytocin is used routinely without medical indication, and ends in the erroneous use of oxytocin, and risk of labour dystocia arise. In Spain, according to the National Health System the rate of oxytocin use during labour is 53.3%, in pregnant women with spontaneous onset of labour, which is high and is far from the expected standard (expected standard of 5 to 10%, as an indicator of good practice). The partogram is one of the conventional obstetric tools used in labour wards, specially the World Health Organization partogram with the four-hours action line, which is widely used and it serves to give a graphic content and a global vision of the evolution and medication given in a concrete women in labour, although a routine use of partogram is not recommended, and new studies are needed to stablish the effectiveness of the partograph. There are frequent professional errors using conventional partogram and this justify the need for a tool different from the usual ones. The algorithm of care in normal and in disrupted labour recommended by The National Institute for Health and Clinical Excellence (NICE) guidelines is complex.
The tool the investigators have designed is A-BIRTHPERFORM digital tool for professionals and consists in helping applying the Intrapartum Care´s NICE Guidelines algorithms to help decision-making.
Objective: The aim of the study will be to analyze if the use of A-BIRTHPERFORM contributes to improve perinatal results by reducing instrumental deliveries and caesarean sections.
Methods: Design: randomized controlled trial. Participants: The study will be conducted in 4 maternity hospitals of different autonomous communities of Spanish. Participants will be women from 18 to 41 years of age, pregnant at term between 37 and 41 weeks gestation, with spontaneous onset of labour or induced labour and with low or medium obstetric risk. Participants will be randomized to receive professional care during delivery using A-BIRTHPERFORM or assigned to conventional partogram care. The control group will be subject to traditional care through the use of conventional partogram used in each hospital following the labour care guidelines of each participant hospital. The experimental group will be cared by professionals using A-BIRTHPERFORM during the whole labour process.
Discussion: A-BIRTHPERFORM could help improve the use of NICE Guidelines on Intrapartum Care, and could help reducing the use of oxytocin, decreasing instrumented deliveries and severe perineal lacerations. The digital tool aims to provide standardization and systematization to childbirth care and to serve as a communication tool between team members.
This tool could allow the professional to freely access it from any digital device, not necessarily located at the counter or reception of the maternal unit, which facilitates personal reflection on labour progress and with the team, in order to improve health results for women and their families.
Conditions
- Labor Complication
Interventions
- DEVICE
-
A-BIRTHPERFORM digital tool
use of A-BIRTHPERFORM digital tool
Sponsors & Collaborators
-
Hospital del Mar
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 42 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-06-30
- Primary Completion
- 2021-06-30
- Completion
- 2022-06-30
More Related Trials
-
The Influence of Oxytocin on Intrapartum Fetal Well-being and Delivery Outcomes in Patients Receiving Epidural Analgesia
NCT06403982 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Reducing Neonatal Morbidity by Discontinuing Oxytocin During the Active Phase of 1st Stage of Labor
NCT03991091 ·Status: COMPLETED ·Phase: PHASE4
-
Air Versus Saline Solution for the Localization of the Epidural Space in Labour Analgesia
NCT02792933 ·Status: COMPLETED ·Phase: NA
-
Induction of Labor With Oxytocin: When Should Oxytocin be Held?
NCT00957593 ·Status: COMPLETED ·Phase: NA
-
Oxytocin Regimen to Prevent Atony and Postpartum Hemorrhage During Vaginal Delivery: 3-arm RCT
NCT00790062 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
NCT02008591 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Low-dose and High-dose Oxytocin Regimens for Labor Augmentation
NCT02487797 ·Status: COMPLETED ·Phase: PHASE4
-
High Dose Versus Low Dose Oxytocin for Augmentation of Delayed Labour
NCT01587625 ·Status: COMPLETED ·Phase: NA
-
Assessment of Pelvis Diameters as a Predictor for the Mode of Delivery ,Using Non-invasive, Ultrasound Based Measurements
NCT01093144 ·Status: UNKNOWN ·Phase: NA
-
Oxytocin Receptor Expression in Pregnancy
NCT03907735 ·Status: ACTIVE_NOT_RECRUITING
-
Trial of Underwater Birth
NCT07313319 ·Status: RECRUITING ·Phase: NA
-
Head-perineum Distance and Delivery Mode
NCT04771091 ·Status: COMPLETED ·Phase: NA
-
Labour Augmentation by Means of Oxytocin - Obstetric Outcome and Women's Experiences
NCT01263158 ·Status: COMPLETED ·Phase: NA
-
Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
NCT02908126 ·Status: TERMINATED ·Phase: PHASE1
-
Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon
NCT01139801 ·Status: COMPLETED ·Phase: NA
-
Labor Induction After Failed Induction With Dinoprostone.
NCT04597333 ·Status: COMPLETED ·Phase: NA
-
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring and Nonlaboring Patients by Practicing Clinicians
NCT01730963 ·Status: COMPLETED
-
How Long Can Labor Last? Person Centred Care During Labor to Increase Safety for Women and Newborn
NCT06420453 ·Status: COMPLETED
-
The Study of Giving Birth, a Study About Treatment of Labor Dystocia
NCT04649593 ·Status: COMPLETED ·Phase: NA
-
The Comparison of Oxytocin Induced Labor and Cook Balloon Induced Labor
NCT02202083 ·Status: UNKNOWN ·Phase: PHASE4
-
Active Versus Expectant Management of the Third Stage of Labor
NCT00473707 ·Status: COMPLETED ·Phase: NA
-
Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
NCT04949633 ·Status: RECRUITING ·Phase: PHASE3
-
Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour
NCT04760496 ·Status: COMPLETED ·Phase: PHASE4
-
A Randomized, Control Trial for Preinduction Cervical Ripening
NCT00393731 ·Status: COMPLETED ·Phase: PHASE2
-
Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes
NCT03310333 ·Status: UNKNOWN ·Phase: PHASE4