Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371742
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2024-03-27
Brief Title:
Study of the Fluid Intake Effect During Labour
Sponsor:
Egas Moniz - Cooperativa de Ensino Superior CRL
Organization:
Egas Moniz - Cooperativa de Ensino Superior CRL
Study Overview
Official Title:
The Effect of Fluid Intake on the Duration of Labour Type of Delivery Well-being of the Pregnant Woman and the Newborn
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ingestion during labor is an issue that has attracted the attention of the scientific community in recent decades with different practices occurring in different countries However the scientific evidence of the risk benefit of fluid intake in labor is still not fully understood The aim of this study was to contribute with data that allow the evaluation of an eventual relationship between the amount of fluid ingested during labor and the type of delivery the duration of labor the occurrence of nausea and vomiting and the value of the Index of Apgar at the 1st and 5th minutes of the newborns life An observational study with a convenience sample of 144 parturient from two hospitals of Portugal were employed The analysis was based on recording the before mentioned variables and potentially confounding variables In order to control for potential sources of bias in the study and to guarantee the homogeneity of the sample in the specific statistical treatment of each dependent variable an observation grid was drawn up for all the participants in the study Twenty eight of the parturient the parturients ambulation labour analgesia food intake during labour the use of oxytocin during labour the occurrence of postpartum complications the birth weight of the newborn and the occurrence of birth complications
Detailed Description:
To carry out the study authorization was requested from the National Data Protection Commission Each participant was given a code to ensure the confidentiality and protection of the data collected The data obtained was recorded on coded sheets without any element identifying the participant and entered into a database accessed only by the researcher in charge and processed using the identification code assigned to the participants The study was also authorized by the Ethics Committee of the Egas Moniz School of Health and Science by the Ethics Committee of Garcia de Orta Hospital and by Barreiro Hospital The data was collected after the informed consent of the pregnant womancouple using an observation grid that allowed the variables to be observed and recorded in accordance with the Declaration of Helsinki
This is an observational study since the researcher chose not to interfere in the clinical practice of each of the hospital institutions and nothing was imposed on the pregnant womancouple
The analysis was based on recording the variables mentioned above and potentially confounding variables In order to control for potential sources of bias in the study and to guarantee the homogeneity of the sample in the specific statistical treatment of each dependent variable an observation grid was drawn up for all the participants in the study including in addition to the amount and type of fluid ingested the type of labour the assessment of the duration of labour expressed in the partogram a sheet recording the progress of labour in the parturients file the occurrence of nausea and vomiting during labour Apguar index AI at the first and fifth minute of life the age of the parturient the parturients ambulation labour analgesia food intake during labour the use of oxytocin during labour the occurrence of complications in the postpartum period the weight of the Newborn NB at birth and the occurrence of complications during labour
The target population was primiparous women with low-risk full-term pregnancies with cephalic fetuses and spontaneous onset of labour The sample size was determined by the Gpower 31 programme according to the statistical analysis to be carried out and with a 95 confidence interval which suggested an sample number of 150 This was a convenience sample made up of pregnant women who had signed an informed consent form at Garcia de Orta Hospital and at Barreiro Hospital and who met the inclusion criteria All parturients with associated pathologies either previous or during pregnancy medium or high-risk pregnancies and who develop problems during labour such as hyperthermia hypotension hypoglycaemia lipothymia fetuses with cardiotocographic alterations and NB with tight cervical circles at birth were excluded Pregnant women who did not walk and who were not given intravenous oxytocin during labour were also excluded in order to standardize the sample as were all the parturients who did not consent to their data being used
An assessment was made of the volume capacity of the water glasses using duly certified 50 mL syringes in order to calibrate and control the correct measurement of the amount of water ingested The water was measured using a graduated glass since its water intake policy is governed by the formula 1mlkghour of clear liquids water or tea Subsequently an observation grid was drawn up for all the participants in the study and the data was collected and integrated into the observation grid directly from the pregnant women present in the delivery room
The data was processed and analysed statistically using IBM SPSS version 24 software Taking into account the data collected on the observation grid the sample was descriptively analysed the assumptions for applying statistical methods were checked and the data was statistically analysed Bearing in mind the objectives of this study to see if there is an association between the amount of water ingested during labour LW and the type of delivery the duration of LW the occurrence of nausea and vomiting the Apgar score AI at the 1st and 5th minute of life of the Newborn NB and the different nature of the variables scalar - total amount of fluid ingested mL duration of labour hours and nominal - type of delivery occurrence of nausea and vomiting AI at the 1st and 5th minutes different statistical analyses were used to confirm the null hypothesis as well as testing the normality of the sample distribution for the scalar variables duration of labour using the Kolmogorov-Smirnov and Shapiro-Wilk tests As the distribution of the variable was not normal ρ 005 The investigators analysed it using non-parametric tests using Spearmans Rho Correlation Coefficient For the remaining variables the Logistic Regression test was applied since this statistical analysis makes it possible to estimate the chances of a given event occurring given a set of variables In this case for example to identify the risk of dystocia for each mL of fluid ingested
This is an observational study since the researcher chose not to interfere in the clinical practice of each of the hospital institutions and nothing was imposed on the pregnant womancouple
The analysis was based on recording the variables mentioned above and potentially confounding variables In order to control for potential sources of bias in the study and to guarantee the homogeneity of the sample in the specific statistical treatment of each dependent variable an observation grid was drawn up for all the participants in the study including in addition to the amount and type of fluid ingested the type of labour the assessment of the duration of labour expressed in the partogram a sheet recording the progress of labour in the parturients file the occurrence of nausea and vomiting during labour Apguar index AI at the first and fifth minute of life the age of the parturient the parturients ambulation labour analgesia food intake during labour the use of oxytocin during labour the occurrence of complications in the postpartum period the weight of the Newborn NB at birth and the occurrence of complications during labour
The target population was primiparous women with low-risk full-term pregnancies with cephalic fetuses and spontaneous onset of labour The sample size was determined by the Gpower 31 programme according to the statistical analysis to be carried out and with a 95 confidence interval which suggested an sample number of 150 This was a convenience sample made up of pregnant women who had signed an informed consent form at Garcia de Orta Hospital and at Barreiro Hospital and who met the inclusion criteria All parturients with associated pathologies either previous or during pregnancy medium or high-risk pregnancies and who develop problems during labour such as hyperthermia hypotension hypoglycaemia lipothymia fetuses with cardiotocographic alterations and NB with tight cervical circles at birth were excluded Pregnant women who did not walk and who were not given intravenous oxytocin during labour were also excluded in order to standardize the sample as were all the parturients who did not consent to their data being used
An assessment was made of the volume capacity of the water glasses using duly certified 50 mL syringes in order to calibrate and control the correct measurement of the amount of water ingested The water was measured using a graduated glass since its water intake policy is governed by the formula 1mlkghour of clear liquids water or tea Subsequently an observation grid was drawn up for all the participants in the study and the data was collected and integrated into the observation grid directly from the pregnant women present in the delivery room
The data was processed and analysed statistically using IBM SPSS version 24 software Taking into account the data collected on the observation grid the sample was descriptively analysed the assumptions for applying statistical methods were checked and the data was statistically analysed Bearing in mind the objectives of this study to see if there is an association between the amount of water ingested during labour LW and the type of delivery the duration of LW the occurrence of nausea and vomiting the Apgar score AI at the 1st and 5th minute of life of the Newborn NB and the different nature of the variables scalar - total amount of fluid ingested mL duration of labour hours and nominal - type of delivery occurrence of nausea and vomiting AI at the 1st and 5th minutes different statistical analyses were used to confirm the null hypothesis as well as testing the normality of the sample distribution for the scalar variables duration of labour using the Kolmogorov-Smirnov and Shapiro-Wilk tests As the distribution of the variable was not normal ρ 005 The investigators analysed it using non-parametric tests using Spearmans Rho Correlation Coefficient For the remaining variables the Logistic Regression test was applied since this statistical analysis makes it possible to estimate the chances of a given event occurring given a set of variables In this case for example to identify the risk of dystocia for each mL of fluid ingested
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None