Pregnancy Clinical Trial
— HYDRATAOfficial title:
Effectiveness "HIDRATACION OPTIMA " During Labor in Reducing Time Dilation and Expulsion, Cesarean, Fever and Dehydration
Aim. To evaluate the efficacy of optimizing hydration during labor in nulliparous women with
respect to reducing the duration of dilation and the second stage of labor, lowering the
incidence of Cesarean sections and fever, and also with respect to changes in sodium and
osmolarity in blood and urine, and 24 hour diuresis.
Background. In the international scientific community there is a lack of consensus regarding
the most suitable hydration strategies to be used in the attention of nulliparous women
during low risk birth. Insufficient hydration during labor is associated with increased
maternal and neonatal morbidity.
Design. A randomized, controlled clinical trial with allocation concealment and masking
during the evaluation of the results.
Methods. A study of nulliparous women whose births and newborn are attended in the Obstetric
Service of a University Hospital. The women will be randomized to two groups: the "optimal
hydration" group, that will be guaranteed 300 ml/h (intravenous crystalloids and water) with
a minimum diuresis of 400 ml/24h; and the "variability in hydration" group, comprised of the
administration of intravenous and clear liquid volumes, without any established perfusion
rate, based on criteria established by the healthcare professional attending the birth, and
without established minimum diuresis. Mother outcomes: duration of labor, Cesarean section,
fever, dehydration. Newborn outcomes: distress, hypoglycemia, hyponatremia, jaundice, weight
loss in 48h, breastfeeding difficulties. Analysis will be per-protocol. Statistical
significance will be set at p<0.05 Discussion. The findings obtained in this study will
provide new evidence for considering the benefits of providing women with suitable optimized
hydration during labor. Diminishing the clinical practice variability related to hydration
strategies applied to nulliparous women attended during labor through the use of a
decision-making algorithm to administer optimal hydration, would imply improved health and
safety for mothers and their newborn together with reduced maternal and neonatal morbidity.
Funding granted in 2015 by the Spanish Health Research Fund (PI 15/00897, Ministry of
Health).
Keywords: hydration; dehydration; adverse events; labor; Cesarean section, fever.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 29 Years to 35 Years |
Eligibility |
Inclusion Criteria: Women who: - Are 18 years-of-age or older; - With gestation between 37-41+3 weeks - Have signed an informed consent form. Exclusion Criteria: The following exclusion criteria will apply: - Women who do not have sufficient understanding of the Spanish language or those with whom communication will be difficult - Women with a multiple gestation - Gestation with high maternal or neonatal risk - Maternal pathology (metabolic diseases, preeclampsia, eclampsia, etc.) - Fetal pathology - Precipitated delivery; fetal death. Criteria for leaving the study: - Severe maternal complications during the immediate or intermediate postpartum periods that require admittance to the Intensive care Unit - Neonatal complications that require admittance to the Neonatology Service for more than 48 hours - If, once the study has started, the participant fails to cooperate during follow-up (delivery, during the immediate or intermediate postpartum periods) or decides to discontinue their participation. |
Country | Name | City | State |
---|---|---|---|
Spain | Puerta de Hierro Majadahonda University Hospital | Madrid |
Lead Sponsor | Collaborator |
---|---|
Puerta de Hierro University Hospital |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | duration of labor | total duration from onset of labor until the birth. | 24 hours |
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