Randomized Controlled Trial Comparing a Specific Intervention by Midwife to Address the Fear of Childbirth.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Neonatal outcomes of childbirth
研究概览
简要总结
The main objective of the research is to implement a specific intervention directed by midwives to address the fear of childbirth in the prenatal and intrapartum periods. The results obtained in the specific intervention group under study will be compared with those of the control group that will follow the usual care.
Fear of childbirth is defined as a state of intense anxiety that leads some women to fear childbirth, provoking a response that can influence the course of pregnancy, childbirth, and postpartum, as well as well-being and child development. Beneficial results have been shown in counseling, and prenatal education for childbirth, appropriate therapies to prevent, or at least reduce this suffering and its consequences. These interventions must be specific to see an improvement in symptoms, and must use a combination of various approaches to promote not only a reduction in fear, but a positive birth experience.
The population under study will be made up of pregnant women with a fear of childbirth detected in the second trimester of gestation. The sample will be recruited in the area of prenatal diagnosis of the Hospital Materno Infantil of Canarians (HUMIC). The start of the recruitment of participants is expected in June 2021, the online prenatal education intervention in August 2021 and the intrapartum intervention in October 2020. The intervention is expected to end in April 2022. It will be carried out a consecutive sampling until reaching the estimated sample size of 190 participants with fear of severe delivery who will be randomized to one of the two arms of the trial.
详细描述
A parallel group randomized controlled trial will be conducted in a cohort of women with a high level of fear of childbirth. Participants will be randomized to one of two arms: specific intervention group or usual care control group.
Initially, the fear of childbirth and associated factors will be evaluated in the second trimester of pregnancy, between weeks 20 and 24 of gestation. This will be followed by prenatal intervention in women who meet the inclusion criteria. In the intervention group, it will begin around week 30 of gestation, supplementing the interventions that are usually offered to all pregnant women, and that the control group will also receive. The results of the prenatal phase will be evaluated by means of the changes in the value of fear of childbirth in each group.
The intranatal intervention begins after 37 weeks of gestation, once the pregnant women attend the obstetric-gynecological emergency service. The participants will remain in the same group assigned in the first part, intervention or intrapartum control. The efficacy of the intervention will be evaluated after delivery by comparing the changes in the value of fear of childbirth, experience, satisfaction, and obstetric and neonatal outcomes between both groups.
Secondarily, an observational, descriptive study is proposed, with an analytical component and a cross section on aspects such as: the factors detected in the pregnant women who participated in the initial evaluation of fear of childbirth, the aspects related to the care received during pregnancy and childbirth in the participants of both groups, and the information obtained in the evaluation of the experience of midwives about fear of childbirth as well as the details of the intrapartum care offered during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
A single blind will be performed by masking the data analysis. It will not be carried out in blinding of the participants due to impossibility given the nature of the education study. As far as possible, the control group will not be identified as pregnant women with severe fear of childbirth in the delivery area, since it is about receiving the usual care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 18 years of age
- •20-24 weeks of gestation
- •Fear of childbirth
- •Normal morphological ultrasound.
排除标准
- •Online questionnaire disability
- •Videoconference disability
- •Incomplete questionnaires
- •Language barrier.
- •Withdrawal criteria:
- •Elective caesarean section
- •Delivery before 37 weeks of gestation
- •Non-attendance at educational sessions
- •Delivery in a place other than HUMIC
- •Fetal death
- •Decline of informed consent.
结局指标
主要结局
Neonatal outcomes of childbirth
时间窗: Before 10 days postpartum
Describe and compare the following neonatal outcomes of childbirth between both study groups
Change in the value of fear of childbirth
时间窗: At 20-24 and 37 weeks gestation
Describe and compare the value of fear of childbirth measured by the Wijma Expectations Questionnaire in version A in its validated version into Spanish, in the prenatal education intervention group and in the control group between 20-24 weeks of gestation and 37 weeks of gestation. The questionnaire is made up of 31 questions and establishes values from 0 to indicate a lower fear of childbirth to 155, which indicates the maximum value of fear of childbirth.
Postpartum maternal satisfaction
时间窗: Before 10 days postpartum
Evaluate and Compare maternal satisfaction in both study groups using Childbirth Experience Questionnaire in its validated version into Spanish. Satisfaction is evaluated through 22 questions, the highest score of 88 reporting greater satisfaction, and the lowest score of 22 reporting less satisfaction.
Value of fear of postnatal childbirth
时间窗: Before 10 days postpartum
Describe and compare the value of fear of postnatal childbirth measured by the Wijma Experience Questionnaire in version B, in its validated version into Spanish, in the intranatal intervention group and in the control group.The questionnaire is made up of 33 questions and establishes values from 0 to indicate a lower fear of childbirth to 165, which indicates the maximum value of fear of childbirth.
Obstetric outcomes of childbirth
时间窗: Before 10 days postpartum
Describe and compare the following obstetric outcomes of childbirth between both study groups: type of onset of delivery, epidural use, use of oxytocin, type of completion of delivery, gestational giving to delivery, perineal tear, episiotomy, total duration of delivery
次要结局
- Description of obstetrics data of the participants in the recruitment for the trial.(At 20-24 weeks gestation)
- Description of the sociodemographic data of the participants in the recruitment for the trial..(At 20-24 weeks gestation)
- Description of the birthing preferences of the participants in the recruitment for the trial.(At 20-24 weeks gestation)
- Description of the previous birth experiences of the participants in the recruitment for the trial.(At 20-24 weeks gestation)
- Intrapartum intervention performed by midwives(During the intrapartum intervention, an average of 6 months)
- Compare the change in value of fear of part before and after delivery.(Before 10 days postpartum)
研究者
Sergio Mies Padilla
Principal Investigator
University of Las Palmas de Gran Canaria