Effectiveness and Safety in Maternal and Neonatal Outcomes of Waterbirth Compared to Delivery in Women Using Epidural Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 642
- 试验地点
- 1
- 主要终点
- Maternal infection
研究概览
简要总结
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.
详细描述
At present there is controversy and doubts about the increase in the number of interventions involving the use of epidural analgesia(EA), but there is also controversy about the safety of the use of water, especially in those processes where the birth ends in water, called Waterbirth (WB). 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.
For this purpose, a prospective observational study will be carried out in low-risk pregnant women (who do not present any complication at the time of delivery) who freely choose one or the other method at the beginning of their labor process. For this reason, the socio-demographic characteristics, the obstetric interventions carried out during the process, the results, the possible maternal and neonatal complications, aspects of breastfeeding, as well as the evaluation of the degree of satisfaction will be described and compared between the two groups.
The study was carried out at the Hospital Universitario La Plana, a referral center for normal childbirth, where the healthcare team has experience in the management of both methods. After obtaining the approval of the ethics committee (CEI), recruitment of the cases began and was carried out between June 2020 and February 2023. Overall, 642 cases were recruited, distributed in a total of 359 women who chose water immersion, of whom 40 women subsequently opted for epidural analgesia and 283 women who chose epidural analgesia initially. Women who completed the water birth totaled 263 cases.
The data concerning clinical variables were extracted from the electronic clinical records of the medical history of both the mother and the neonate and subsequently transcribed into a web portal designed to facilitate the transcription of the multiple variables. The final database is exploited from this web portal in Excel format and exported to the Statistical Package for Social Sciences (SPPSS) program version for subsequent analysis.
The variables collected for subsequent analysis are classified into sociodemographic variables, maternal clinical variables, neonatal clinical variables and satisfaction variables.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 46 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •.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.
结局指标
主要结局
Maternal infection
时间窗: Up to 1 month
Presence of any type of maternal infection in the postpartum period (urinary tract infection, endometritis, mastitis or others), YES/NO
Amniotomy
时间窗: 24 hours
If intrapartum amniotomy is needed YES/NO
Number of scalp blood determinations
时间窗: Up to 24 hours
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)
Intrapartum fever
时间窗: Up tu 24 hours
Presence of intrapartum fever YES/NO
Perineal tear
时间窗: Up to 24 hours
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)
Apgar score at five minuts of life of the neonate.
时间窗: Up to 24 hours
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)
Presence of distress neonatal
时间窗: Up to 48 hours
Presence of respiratory distress in the neonate during the first two hours of life. YES/NO
Completion of labor
时间窗: 24 hours
How labor is terminated : Normal in water Normal underwater Instrumented delivery Cesarean section
intrapartum administration of oxytocin
时间窗: 24 hours
Yes/no intrapartum oxytocin required
presence of fetal heart rate abnormalities Frequency of non-reassuring or pathological episodes in the cardiotocographic recording.
时间窗: 24 hours
Frequency of non-reassuring or pathological episodes in the cardiotocographic recording. (Scale)
Number of bladder catheterizations
时间窗: Up to 24 hours
Number of times bladder catheterization is performed during the delivery process (Scale)
Presence of hypoxic ischemic encephalopathy
时间窗: 1 month
Describes whether the neonate has a diagnosis of hypoxic ischemic encephalopathy.
Presence of obstetric emergency
时间窗: Up to 24 hours
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)
Neonatal admission
时间窗: Up to 30 days
Describes if the neonate needs to be admitted to the neonatal unit. YES/NO
Maternal satisfaction
时间窗: Up to 3 days
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.
Apgar score at one minuto of life of the neonate.
时间窗: Up to 24 hours
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)
Arterial cord blood ph
时间窗: Up to 24 hours
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)
Neonatal ventilation support
时间窗: Up to 24 hours
If the neonate requires after birth support with positive ventilation, oxygen administration or intubation. YES/NO
Neonatal sepsis
时间窗: Up to 30 days
Describes whether neonatal sepsis has occurred.YES/NO
Visits to the hospital emergency department during the first month postpartum
时间窗: Up to1 month
Number of urgent hospital visits made by the woman during the first postpartum month. (Scale)
Breastfeeding upon hospital discharge
时间窗: Up to 1 week
Type of breastfeeding established at hospital discharge: Breastfeeding Artificial breastfeeding Mixed breastfeeding
次要结局
- cervical dilatation at the time of choice of analgesic method(Up to 24 hours)
- Duration of the active second stage of labor(Up to 24 hours)
- Breastfeeding chosen after birth(Up to 24 hours)
- Type of latch-on of the baby at the onset of breastfeeding during the first two hours postpartum(Up to 48 hours)
- Length of stay in days(At the time of hospital discharge)
- sex of the newborn(Up to 24 hours)
- group b streptococcus colonization during gestation(Up to 24 hours)
- Duration of the dilatation phase(Up to 24 hours)
- Type of expulsion(Up to 24 hours)
- Reason for admission(Up to 1 month)
- Supplementation during hospital stay(At the time of hospital discharge)
- Management of the third stage of labor(Up to 24 hours)
- newborn birth weight(Up to 24 hours)
研究者
Soledad Carregui Villar
Principal Investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana