UnknownNot Applicable

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

Spain130 participantsStarted 2018-06-01

Plain-language 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.

Who can participate

Age range

29 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

duration of labor

Timeframe: 24 hours

Trial details

NCT IDNCT03607929

SponsorPuerta de Hierro University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31

Contact for this trial

Ana Belen Hernandez Lopez, MSc PhD

+34675529071 anabelen.hernandez2@salud.madrid.org

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