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

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

Interventions

PROCEDURE

optimal

Physiological Saline Solution

PROCEDURE

variability

Other solutions

Sponsors & Collaborators

• Puerta de Hierro University Hospital

  lead OTHER

Principal Investigators

• Ana Belen Hernandez Lopez, Miswife · Midwife

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

29 Years

Max Age

35 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-06-01

Primary Completion

2020-12-31

Completion

2020-12-31

Countries

• Spain

Study Locations