Effectiveness and Safety in Maternal and Neonatal Outcomes in Water Birth.

NCT06429111 | Completed

• 1 other identifier: water birth
• Study Type: observational
• Target: 642
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Natural Childbirth; Water Birth; Neonatal Asphyxia; Outcome, Adverse Birth; Labor Pain; Obstetric Pain

Outcome Measures

Primary Outcomes (21)

• Completion of labor

  How labor is terminated : Normal in water Normal underwater Instrumented delivery Cesarean section

  24 hours

• intrapartum administration of oxytocin

  Yes/no intrapartum oxytocin required

  24 hours

• Amniotomy

  If intrapartum amniotomy is needed YES/NO

  24 hours

• presence of fetal heart rate abnormalities Frequency of non-reassuring or pathological episodes in the cardiotocographic recording.

  Frequency of non-reassuring or pathological episodes in the cardiotocographic recording. (Scale)

  24 hours

• Number of bladder catheterizations

  Number of times bladder catheterization is performed during the delivery process (Scale)

  Up to 24 hours

• Number of scalp blood determinations

  Determination of pH and lactate from fetal scalp blood to study the management of intrapartum fetal hypoxia. Only when when there is suspicion of risk of loss of fetal well-being due to a non-reassuring or pathological cardiotocographic monitor. (Scale)

  Up to 24 hours

• Intrapartum fever

  Presence of intrapartum fever YES/NO

  Up tu 24 hours

• Presence of obstetric emergency

  An obstetric emergency is considered to be the occurrence of any episode of: Cord rupture puerperal hemorrhage Shoulder impaction Manual removal of placenta Risk of loss of fetal well-being (Nominal)

  Up to 24 hours

• Perineal tear

  Injury to the genital tract due to spontaneous trauma as a result of childbirth. These traumas are classified according to Sultan 1999 according to the injury produced: First degree: Injury to the perineal skin and mucosa. Second degree: Injury to perineal muscles without affecting the anal sphincter. Third degree a.- Injury that reaches the external anal sphincter affecting less than 50%. Third degree b.- Injury reaching the external anal sphincter affecting more than 50%. Third degree c.- Injury reaching the complete external anal sphincter and internal anal sphincter. Fourth degree: Injury to the external anal sphincter plus the internal anal sphincter plus the anal epithelium. (Nominal)

  Up to 24 hours

• Apgar score at one minuto of life of the neonate.

  A one-minute assessment of five items that determine a numerical value called the "Apgar test" that evaluates cardiac activity, respiratory effort, reflexes, muscle tone and skin color. If the value is less than or equal to 7, it is interpreted as a poor neonatal adaptation; if it is greater than 7, it is interpreted as an adequate adaptation. (Scale)

  Up to 24 hours

• Apgar score at five minuts of life of the neonate.

  A five minutes assessment of five items that determine a numerical value called the "Apgar test" that evaluates cardiac activity, respiratory effort, reflexes, muscle tone and skin color. If the value is less than or equal to 7, it is interpreted as a poor neonatal adaptation; if it is greater than 7, it is interpreted as an adequate adaptation. (Scale)

  Up to 24 hours

• Arterial cord blood ph

  Value determining the analysis of blood samples from the umbilical cord artery after birth. The purpose of this analysis is to determine the degree of possible fetal hypoxia suffered by the newborn during delivery. The blood sample will be taken without clamping the umbilical cord in the case of late cord. A value lower than 7.10 can be interpreted as a higher risk of fetal hypoxia. (Scale)

  Up to 24 hours

• Neonatal ventilation support

  If the neonate requires after birth support with positive ventilation, oxygen administration or intubation. YES/NO

  Up to 24 hours

• Presence of distress neonatal

  Presence of respiratory distress in the neonate during the first two hours of life. YES/NO

  Up to 48 hours

• Neonatal admission

  Describes if the neonate needs to be admitted to the neonatal unit. YES/NO

  Up to 30 days

• Neonatal sepsis

  Describes whether neonatal sepsis has occurred.YES/NO

  Up to 30 days

• Presence of hypoxic ischemic encephalopathy

  Describes whether the neonate has a diagnosis of hypoxic ischemic encephalopathy.

  1 month

• Maternal infection

  Presence of any type of maternal infection in the postpartum period (urinary tract infection, endometritis, mastitis or others), YES/NO

  Up to 1 month

• Breastfeeding upon hospital discharge

  Type of breastfeeding established at hospital discharge: Breastfeeding Artificial breastfeeding Mixed breastfeeding

  Up to 1 week

• Visits to the hospital emergency department during the first month postpartum

  Number of urgent hospital visits made by the woman during the first postpartum month. (Scale)

  Up to1 month

• Maternal satisfaction

  Measured according to the validation of the Mackey Childbirth Satisfaction Rating Scale. It consists of 34 items grouped in five subscales referring to the woman (9 items), the partner (2 items), the newborn (3 items), the midwife (9 items) and the obstetrician (8 items). It also contains a subscale for overall assessment of the experience (3 items). Each item is evaluated on a 5-point Likert scale ranging from very dissatisfied (1) to very satisfied (5), with a neutral central value. The final score of the scale is obtained by adding the values assigned to each item, so that the higher the score, the greater the satisfaction. Similarly, partial scores can be obtained for each subscale. The questionnaire is offered to the woman in the postpartum period and is collected before discharge from the hospital.

  Up to 3 days

Secondary Outcomes (13)

• cervical dilatation at the time of choice of analgesic method

  Up to 24 hours

• group b streptococcus colonization during gestation

  Up to 24 hours

• Duration of the dilatation phase

  Up to 24 hours

• Duration of the active second stage of labor

  Up to 24 hours

• Type of expulsion

  Up to 24 hours

Study Arms (2)

low-risk pregnant women who freely chooses to use epidural analgesia during labor

* Pregnant women at term with normal pregnancy without the presence of maternal and neonatal risk factors who meet criteria according to the protocol for the use of water and who choose epidural analgesia at the time of admission to the dilatation room in active labor. * Over 17 years of age * Psychic and cognitive capacity for decision making * Willingness to take part in the study and signature of the informed consent form. * Absence of ideomatic barrier

Procedure: Epidural analgesia

low-risk pregnant woman who freely chooses the use of water during childbirt

Pregnant women at term with normal pregnancy without the presence of maternal and neonatal risk factors who meet criteria according to the protocol for the use of water and who choose immersion water at the time of admission to the dilatation room in active labor. * Over 17 years of age * Psychic and cognitive capacity for decision making * Willingness to take part in the study and signature of the informed consent form. * Absence of ideomatic barrier

Procedure: Immersion water

Interventions

Epidural analgesia PROCEDURE

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.

low-risk pregnant women who freely chooses to use epidural analgesia during labor

Immersion water PROCEDURE

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

low-risk pregnant woman who freely chooses the use of water during childbirt

Eligibility Criteria

• Age: 17 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The Hospital Universitario La Plana is the reference center of the Health Department No. 3, is a regional hospital located in the city of Vila-real, province of Castellon. Candidates for participation in the study are full-term pregnant women who meet the inclusion criteria and who are admitted to the dilation room during the active labor period in the Delivery Service of the Hospital Universitario La Plana during the period from April 2020 to June 2023.

You may qualify if:

• Pregnant women at term with normal pregnancy without the presence of maternal and neonatal risk factors that preclude the use of water and epidural analgesia at the time of admission to the delivery room.
• Pregnant women who are 18 years of age or older or who will turn 18 in the year of delivery.
• Have the psychic and cognitive capacity to make decisions.
• Desire to be part of the study and signature of informed consent to participate in the study.

You may not qualify if:

• Presence of any maternal or fetal risk factor that precludes the choice of water or epidural analgesia at the time of admission to the dilation room in active labor.
• Under 17 years of age or under 18 years of age in the year of delivery.
• Ideomatic barrier that makes it impossible for the patient to understand the study and to agree to the informed consent, .Unwillingness to participate or failure to sign the informed consent form.

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: lead
• Universitat Jaume I: collaborator
• Hospital Universitario de la Plana: collaborator

Study Sites (1)

Hospital Universitario La Plana

Vila-real, Castellon, 12540, Spain

Location

Related Publications (16)

• Cluett ER, Burns E, Cuthbert A. Immersion in water during labour and birth. Cochrane Database Syst Rev. 2018 May 16;5(5):CD000111. doi: 10.1002/14651858.CD000111.pub4.

  PMID: 29768662 BACKGROUND

• Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.

  PMID: 29781504 BACKGROUND

• Shaw-Battista J. Systematic Review of Hydrotherapy Research: Does a Warm Bath in Labor Promote Normal Physiologic Childbirth? J Perinat Neonatal Nurs. 2017 Oct/Dec;31(4):303-316. doi: 10.1097/JPN.0000000000000260.

  PMID: 28520654 BACKGROUND

• Lewis L, Hauck YL, Butt J, Hornbuckle J. Obstetric and neonatal outcomes for women intending to use immersion in water for labour and birth in Western Australia (2015-2016): A retrospective audit of clinical outcomes. Aust N Z J Obstet Gynaecol. 2018 Oct;58(5):539-547. doi: 10.1111/ajo.12758. Epub 2018 Jan 17.

  PMID: 29344940 BACKGROUND

• Bovbjerg ML, Cheyney M, Caughey AB. Maternal and neonatal outcomes following waterbirth: a cohort study of 17 530 waterbirths and 17 530 propensity score-matched land births. BJOG. 2022 May;129(6):950-958. doi: 10.1111/1471-0528.17009. Epub 2021 Dec 1.

  PMID: 34773367 BACKGROUND

• Liu Y, Liu Y, Huang X, Du C, Peng J, Huang P, Zhang J. A comparison of maternal and neonatal outcomes between water immersion during labor and conventional labor and delivery. BMC Pregnancy Childbirth. 2014 May 6;14:160. doi: 10.1186/1471-2393-14-160.

  PMID: 24886438 BACKGROUND

• Yu M, Qian H, Gan M. Comparison of different interventions for the reduction of labor pain: A systematic review and network meta-analysis. Medicine (Baltimore). 2024 Mar 8;103(10):e37047. doi: 10.1097/MD.0000000000037047.

  PMID: 38457589 BACKGROUND

• McKinney JA, Vilchez G, Jowers A, Atchoo A, Lin L, Kaunitz AM, Lewis KE, Sanchez-Ramos L. Water birth: a systematic review and meta-analysis of maternal and neonatal outcomes. Am J Obstet Gynecol. 2024 Mar;230(3S):S961-S979.e33. doi: 10.1016/j.ajog.2023.08.034. Epub 2024 Jan 9.

  PMID: 38462266 BACKGROUND

• Seed E, Kearney L, Weaver E, Ryan EG, Nugent R. A prospective cohort study comparing neonatal outcomes of waterbirth and land birth in an Australian tertiary maternity unit. Aust N Z J Obstet Gynaecol. 2023 Feb;63(1):59-65. doi: 10.1111/ajo.13555. Epub 2022 Jul 7.

  PMID: 35796252 BACKGROUND

• Zhang G, Yang Q. Comparative Efficacy of Water and Conventional Delivery during Labour: A Systematic Review and Meta-Analysis. J Healthc Eng. 2022 Mar 29;2022:7429207. doi: 10.1155/2022/7429207. eCollection 2022.

  PMID: 35392147 BACKGROUND

• Ulfsdottir H, Saltvedt S, Edqvist M, Georgsson S. Management of the active second stage of labor in waterbirths compared with conventional births - a prospective cohort study. Midwifery. 2022 Apr;107:103283. doi: 10.1016/j.midw.2022.103283. Epub 2022 Feb 8.

  PMID: 35172265 BACKGROUND

• Reviriego-Rodrigo E, Ibargoyen-Roteta N, Carregui-Vilar S, Mediavilla-Serrano L, Uceira-Rey S, Iglesias-Casas S, Martin-Casado A, Toledo-Chavarri A, Ares-Mateos G, Montero-Carcaboso S, Castello-Zamora B, Burgos-Alonso N, Moreno-Rodriguez A, Hernandez-Tejada N, Koetsenruyter C. Experiences of water immersion during childbirth: a qualitative thematic synthesis. BMC Pregnancy Childbirth. 2023 May 29;23(1):395. doi: 10.1186/s12884-023-05690-7.

  PMID: 37248449 BACKGROUND

• Burns E, Feeley C, Hall PJ, Vanderlaan J. Systematic review and meta-analysis to examine intrapartum interventions, and maternal and neonatal outcomes following immersion in water during labour and waterbirth. BMJ Open. 2022 Jul 5;12(7):e056517. doi: 10.1136/bmjopen-2021-056517.

  PMID: 35790327 BACKGROUND

• Vanderlaan J, Hall P. Systematic Review of Case Reports of Poor Neonatal Outcomes With Water Immersion During Labor and Birth. J Perinat Neonatal Nurs. 2020 Oct/Dec;34(4):311-323. doi: 10.1097/JPN.0000000000000515.

  PMID: 33079805 BACKGROUND

• Ulfsdottir H, Saltvedt S, Georgsson S. Women's experiences of waterbirth compared with conventional uncomplicated births. Midwifery. 2019 Dec;79:102547. doi: 10.1016/j.midw.2019.102547. Epub 2019 Sep 30.

  PMID: 31610362 BACKGROUND

• Committee Opinion No. 679 Summary: Immersion in Water During Labor and Delivery. Obstet Gynecol. 2016 Nov;128(5):1198-1199. doi: 10.1097/AOG.0000000000001765.

  PMID: 27776069 BACKGROUND

MeSH Terms

Conditions

Asphyxia Neonatorum; Pregnancy Complications; Labor Pain

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Soledad Carregui Vilar, Midwife

  Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 24, 2024
• Study Start: June 6, 2020
• Primary Completion: February 24, 2023
• Study Completion: March 24, 2023
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

ES (1)