Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06371742 |
| Other study ID # |
539HydrationNutr |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2017 |
| Est. completion date |
September 14, 2017 |
Study information
| Verified date |
April 2024 |
| Source |
Egas Moniz - Cooperativa de Ensino Superior, CRL |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 newborn's 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 parturient's 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.
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 woman/couple, 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
woman/couple.
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 parturient's 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 parturient's
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 3.1® 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 1ml/kg/hour 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 ≤ 0.05. The investigators analysed it using non-parametric tests using Spearman's 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.
