NCT06371742

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2017

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

April 17, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

March 27, 2024

Last Update Submit

April 15, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • Type of labour

    The labour type was registered taken in account if eutocic, cup, forceps, caesarean section.

    During the labour

  • Duration of labour

    The mean value of labour duration in hours (h)

    During the labour

  • Occurrence of nausea and vomiting

    The frequency of nausea and vomiting episodes in number

    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.

    At the 1st and 5th minute of the newborn's life

Interventions

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).

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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%).

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egas Moniz School of Health and Science

Almada, Monte de Caparica, 2829-699, Portugal

Location

MeSH Terms

Conditions

Obstetric Labor Complications

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Alexandra Bernardo, PhD

    Egas Moniz School of Health and Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2024

First Posted

April 17, 2024

Study Start

February 1, 2017

Primary Completion

July 14, 2017

Study Completion

September 14, 2017

Last Updated

April 17, 2024

Record last verified: 2024-04

Locations