Continuous care during labor by a maternity care assistant will reduce the usage of an epidural and will reduce complications and is therefore costeffective and increases patient satisfaction about their labor experience
ID
Bron
Verkorte titel
Aandoening
Vaginal birth
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Usage of epidural analgesia during labor
Achtergrond van het onderzoek
Background
To improve perinatal outcome, in 2009 the Steering Committee for Pregnancy and Childbirth in the Netherlands advised to implement continuous care during labor, although clear data on cost effectiveness are lacking. Despite a marked rise in the use of epidural anesthesia, current obstetrical caregivers are not able to supply continuous care for more than 70% of women. In the Dutch system, maternity care assistants supply care during the last stages of labor and the question is whether to extent care to a longer period of time would be a cost effective intervention.
Methods
We propose an RCT on continuous care compared to care as usual. All multiparous and nulliparous women with an intention to a vaginal delivery, with understanding of the Dutch language and > 18 years of age can be included. The intervention consist of continuous care by a trained maternity assistant (MA) from the moment the obstetrical caregiver states labor has started.
The primary outcome will be use of epidural analgesia. Secondary outcomes are mode of delivery, complications, patient satisfaction and cost effectiveness which will be calculated by QALY per prevented EA based on utility index from the EQ-5D and usage of healthcare. Standardized sensitivity analysis will be done to quantify the outcome and a budget impact analysis will be done . In order to show a reduction from 25% to 17% in the primary outcome 2x496 women are needed
Doel van het onderzoek
Continuous care during labor by a maternity care assistant will reduce the usage of an epidural and will reduce complications and is therefore costeffective and increases patient satisfaction about their labor experience
Onderzoeksopzet
Inclusion started 30-08-2018
Onderzoeksproduct en/of interventie
Continuous support during labor from the moment midwife states labor has started by a maternity care assistant
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Planned vaginal birth
Women from 18 years or older
Pregnancy in third trimester
Living in the region of south Limburg
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Planned caesarean
Not able to read informed consent (knowledge of Dutch language)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiƫnten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL8065 |
CCMO | NL51853.068.17 |