CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 642 enrolled
Drug / intervention
Epidural analgesia +1 moreprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06429111
NCT06429111N/ACompleted

Effectiveness and Safety in Maternal and Neonatal Outcomes of Waterbirth Compared to Delivery in Women Using Epidural Analgesia

In Brief

An observational study evaluating Epidural analgesia and Immersion water for Natural Childbirth and 5 related conditions. Completed, enrolled 642 participants across 1 site.

Detailed Summary

Childbirth is a unique and non-transferable experience in the life of a woman, her partner and her family. It is a very intense process that requires accompaniment and, in the vast majority of cases, requires analgesic support in order to overcome this life event in an optimal and atraumatic way. Among the analgesic methods for pain relief during the labor process, there are pharmacological and non-pharmacological methods. From the evidence we know that the most effective pharmacological method is epidural analgesia (EA), while the most recognized non-pharmacological method is immersion in hot water (bathtub) for dilatation and delivery, called waterbirth(WB) At present there is controversy and doubts about the increase in the number of interventions involving the use of epidural analgesia, but there is also controversy about the safety of the use of water, especially in those processes where the birth ends in water. Given the popularity of these two methods, the aim is to study and compare the maternal and neonatal outcomes derived from the use of both methods in order to provide greater knowledge to women in their decision making.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 24, 2024
Enrollment StartJun 6, 2020
Primary CompletionFeb 24, 2023
Study CompletionMar 24, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 2.1 years ago

Interventions

Epidural analgesiaprocedure

Consists of a central nerve block by injecting a local anesthetic near the nerves that transmit pain, in the lumbar region, for pain relief during labor.

Immersion waterprocedure

Consists of the use of hot water immersion in a birthing tub during labor and/or delivery.