A-BIRTHPERFORM Versus Conventional Partogram in the Improvement of Birth Results

NCT04009993 | Unknown

• 1 other identifier: SLT0 06/17/0 0 011
• Study Type: interventional
• Target: 969
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

digital tool; decision making; labour process; birth results

Outcome Measures

Primary Outcomes (1)

• Incidence of non-spontaneous vaginal births

  Investigator will be making this evaluation after birth, evaluating the data obtained from the conventional partogram (in the control group) and from the A-BIRTHPERFORM tool (in the intervention group). The measurements or variables that will be used are: data of the progress of labour entered against time, cervical dilatation, record of start oxytocin use if necessary, time of birth, and birth mode in each group of the trial

  Immediately after the birth

Secondary Outcomes (2)

• Percentage of compliance with NICE clinical guidelines on artificial rupture of membranes technique

  Immediately after the birth

• Percentage of compliance with NICE clinical guidelines on oxytocin use during labour

  Immediately after the birth

Study Arms (2)

A-BIRTHPERFORM digital tool

EXPERIMENTAL

interactive partogram that maternity care professionals of the experimental group use, in interactive and device will guide the professional thought the NICE guidelines on labour care

Device: A-BIRTHPERFORM digital tool

control group with conventional partogram use

NO INTERVENTION

Conventional care in each participant hospital, with conventional partogram in each centre

Interventions

A-BIRTHPERFORM digital tool DEVICE

use of A-BIRTHPERFORM digital tool

A-BIRTHPERFORM digital tool

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational age: 37-41 weeks
• Spontaneous and induced onset of labour
• Women with low and medium risk during labour and birth with cephalic presentation fetus

You may not qualify if:

• Premature
• High risk pregnancies and labour
• Malpositions of the fetus

Sponsors & Collaborators

• Hospital del Mar: lead

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Laura GL Garcia-Lausin

CONTACT

0034 686902138; lgarcia1@imim.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: July 8, 2019
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share