HIDRATA Study: Efficacy of a Hydration Protocol in Nulliparous Women During Labor

NCT03607929 | Unknown

• 2 other identifiers: PuertadeHierroPI15/00897
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Long; Nulliparity; Premature Rupture of Membrane; Pregnancy, Prolonged; Pregnancy

Keywords

ARE; deshydration; adverse events; cesarean; fever

Outcome Measures

Primary Outcomes (1)

• duration of labor

  total duration from onset of labor until the birth.

  24 hours

Study Arms (2)

optimal and hydration

EXPERIMENTAL

Physiological Saline Solution 300 ml/h AND drink freely mineral water during labor

Procedure: optimal

variability and hydration

ACTIVE COMPARATOR

Other Solutions \>o \< 300 ml/h AND uncontrolled drink during labor

Procedure: variability

Interventions

optimal PROCEDURE

Physiological Saline Solution

Also known as: controlled

optimal and hydration

variability PROCEDURE

Other solutions

Also known as: uncontrolled

variability and hydration

Eligibility Criteria

• Age: 29 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are 18 years-of-age or older;
• With gestation between 37-41+3 weeks
• Have signed an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead

Study Sites (1)

Puerta de Hierro Majadahonda University Hospital

Madrid, 28222, Spain

RECRUITING

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture; Pregnancy, Prolonged; Fever

Interventions

Optimal Pressed Ceramic; Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ana Belen Hernandez Lopez, Miswife

  Midwife

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Belen Hernandez Lopez, MSc PhD

CONTACT

+34675529071; anabelen.hernandez2@salud.madrid.org

Montserrat Solis Muñoz, MSc PhD RN

CONTACT

+341916000; montserrat.solis@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The methodology for carrying out the clinical trial followed the directives proposed in the CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomized trials (Schulz et al. 2010). Randomization and masking Women who fulfill the inclusion criteria will assigned in a masked manner into one of two groups according to a randomization list generated in the hospital's Care Research Unit using Epidat software version 3.1. Allocations will be disclosed through opaque, sealed, consecutively numbered envelopes at the moment the woman is recruited into the study . Given the difficulty of masking allocations from the persons carrying out the intervention and collecting the information, in addition to using objective variable measurement systems, collaborators will be blinded to the results during their analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwife

Model Details: INTERVENTION GROUP " OPTIMAL HYDRATION" LABOR: they will be initiated the administration of crystalloid solutions in continuous perfusion at a rate of 200ml/h, until delivery, alternating each of them: (1)Physiological Serum (2)Physiological Serum (3)Ringer Lactate. The oral intake of mineral water will be promoted, at a rate of 100ml/h. To avoid bias, the mineral water will be administered by the research team. IMMEDIATE PUERPERIUM: Women who have had a low-risk delivery will drink mineral water at a rate of 100ml / h during the two hours of the immediate puerperium. Suspending Hydration i.v. CONTROL GROUP " VARIABILITY IN HYDRATION" The women will be hydrated in accordance with the midwives' experience, training and clinical criteria, either independently or jointly with the attending clinicians (obstetricians, gynecologists and anesthetists).

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: July 31, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)