Labor ComplicationNCT06371742
Study of the Fluid Intake Effect During Labour
An observational study of Labor Complication, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Complication
- What is being tested?
- Liquid ingestion during labour
- How many people
- 144 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Feb 2017to 14 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: An initial analysis of the data collected from the total sample of N=171 showed that 16 per cent (N=27) of parturients did not walk (N=10) or were not given oxytocin (N=17). The use of ambulation and oxytocin speeds up the labour process. Therefore, in order to control labour conditions and external influences, as well as to guarantee the homogeneity of the sample, pregnant women who did not walk or were not given oxytocin were excluded. Therefore, the overall sample considered for the descriptive analysis was N= 144. The overall sample was made up of pregnant women aged between 18 (10.4%) and 39 (0.7%), with an average age of 26.22 ± 5.42. The average weight of the pregnant women was 74.06kg ± 11.62, ranging from 52 (1.4%) to 122kg (0.7%), with the average being 70kg (7.6%).
Who may be able to join
- low-risk pregnancies
- term pregnancies (> 37 weeks gestation),
- primiparous pregnancies
- fetuses with cephalic presentation
- with spontaneous onset of labour
- at the beginning of the active phase of labour (> 4cm dilation).
Who cannot join
- parturients with associated pathologies, either previous or during pregnancy, medium or high-risk pregnancies and who develop problems during labour, such as hyperthermia, hypothermia, hypoglycaemia, lipothymia, foetuses with cardiotocographic alterations and NBs with tight cervical circles at birth.
- pregnant women who did not walk and who were not given intravenous (IV) oxytocin during labour
- parturients who did not consent to their data being used.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Egas Moniz School of Health and Science
Almada, Monte de Caparica, 2829-699
About this study
Official title: The Effect of Fluid Intake on the Duration of Labour, Type of Delivery, Well-being of the Pregnant Woman and the Newborn
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.
Read the 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 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.
- Conditions
- Labor Complication
- Being tested
- Liquid ingestion during labour
- Medical subject headings
- Obstetric Labor Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid ingestion during labourOther
An assessment of the volume capacity of the water glasses was carried out using duly certified 50mL syringes in order to calibrate and control the correct measurement of the amount of water ingested. Water is measured using a graduated cup, which is pre-existing in the BP service, since its water intake policy is governed by the formula 1ml/kg/h of clear liquids (water or tea).
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of labour
The labour type was registered taken in account if eutocic, cup, forceps, caesarean section.
Measured: During the labour
Duration of labour
The mean value of labour duration in hours (h)
Measured: During the labour
Occurrence of nausea and vomiting
The frequency of nausea and vomiting episodes in number
Measured: During the labour
Apgar index of the newborn (From 0 to 10)
The apgar index will be analysed by a score from 0 to 10. The 5-minute Apgar score of 7-10 as reassuring, a score of 4-6 as moderately abnormal, and a score of 0-3 as low in the term infant and late-preterm infant and as a nonspecific sign of illness.
Measured: At the 1st and 5th minute of the newborn's life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Feb 2017
- Primary completion14 Jul 2017
- Study completion14 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Bernardo, PhD, Principal investigator, Egas Moniz School of Health and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371742
- Sponsor's protocol ID
- 539HydrationNutr
- Status last verified
- Apr 2024
- First submitted
- 27 Mar 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluid Intake on the Duration of Labour, Type of Delivery, Well-being of the Pregnant Woman and the Newborn
- ClinicalTrials.gov ID
- NCT06371742
- Acronym / sponsor ID
- 539HydrationNutr
- Conditions
- Labor Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Sep 2017 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- An initial analysis of the data collected from the total sample of N=171 showed that 16 per cent (N=27) of parturients did not walk (N=10) or were not given oxytocin (N=17). The use of ambulation and oxytocin speeds up the labour process. Therefore, in order to control labour conditions and external influences, as well as to guarantee the homogeneity of the sample, pregnant women who did not walk or were not given oxytocin were excluded. Therefore, the overall sample considered for the descriptive analysis was N= 144. The overall sample was made up of pregnant women aged between 18 (10.4%) and 39 (0.7%), with an average age of 26.22 ± 5.42. The average weight of the pregnant women was 74.06kg ± 11.62, ranging from 52 (1.4%) to 122kg (0.7%), with the average being 70kg (7.6%).
Key inclusion criteria (6 listed)
- low-risk pregnancies
- term pregnancies (> 37 weeks gestation),
- primiparous pregnancies
- fetuses with cephalic presentation
- with spontaneous onset of labour
Key exclusion criteria (3 listed)
- parturients with associated pathologies, either previous or during pregnancy, medium or high-risk pregnancies and who develop problems during labour, such as hyperthermia, hypothermia, hypoglycaemia, lipothymia, foetuses with cardiotocographic alterations and NBs with tight cervical circles at birth.
- pregnant women who did not walk and who were not given intravenous (IV) oxytocin during labour
- parturients who did not consent to their data being used.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid ingestion during labourAn assessment of the volume capacity of the water glasses was carried out using duly certified 50mL syringes in order to calibrate and control the correct measurement of the amount of water ingested. Water is measured using a graduated cup, which is pre-existing in the BP service, since its water intake policy is governed by the formula 1ml/kg/h of clear liquids (water or tea). | Other | – |
Primary outcome
Type of labour
Time frame: During the labour
The labour type was registered taken in account if eutocic, cup, forceps, caesarean section.
Duration of labour
Time frame: During the labour
The mean value of labour duration in hours (h)
Occurrence of nausea and vomiting
Time frame: During the labour
The frequency of nausea and vomiting episodes in number
Apgar index of the newborn (From 0 to 10)
Time frame: At the 1st and 5th minute of the newborn's life
The apgar index will be analysed by a score from 0 to 10. The 5-minute Apgar score of 7-10 as reassuring, a score of 4-6 as moderately abnormal, and a score of 0-3 as low in the term infant and late-preterm infant and as a nonspecific sign of illness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Bernardo, PhD principal investigator
Egas Moniz School of Health and Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Complication, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of labour (time frame: During the labour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.