Intervention by Midwife to Address the Fear of Childbirth
- Conditions
- Fear of Childbirth
- Interventions
- Behavioral: Prenatal usual educationBehavioral: Online prenatal specific educationBehavioral: Intrapartum specific supportBehavioral: Intrapartum usual support
- Registration Number
- NCT05000203
- Lead Sponsor
- University of Las Palmas de Gran Canaria
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 214
- Over 18 years of age
- 20-24 weeks of gestation
- Fear of childbirth
- Normal morphological ultrasound.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Specific intervention for fear of childbirth Intrapartum specific support Online education intervention Participants randomly assigned to the experimental group will be informed by telephone call of their inclusion in the first phase of the trial. Participants in the intervention group will be encouraged to attend routine consultations with their midwife and obstetrician, as well as to take advantage of the group maternal education that participants usually develop in their health center. Specific intranatal support An experimental group will be carried out with a specific support intervention in the obstetric-gynecological emergency area that will supplement the one usually provided to all pregnant women. At the end of the participant's stay within the emergency area due to hospital discharge, admission to the ward, or the end of the pregnancy, the collaborating midwife will fill out an online form designed to monitor the care offered. Said form will also be completed at the end of the work shift if the participant's care continues. Routine intervention for fear of childbirth Prenatal usual education Usual care Participants randomly assigned to the control group will be informed by telephone call of their inclusion in the first phase of the trial. The process under study will be explained in detail, resolving any doubts at that time. Regular intranatal support The participants in the control group will not be identified as pregnant women with fear of childbirth, and will receive the usual care in the obstetric-gynecological emergency area. Routine intervention for fear of childbirth Intrapartum usual support Usual care Participants randomly assigned to the control group will be informed by telephone call of their inclusion in the first phase of the trial. The process under study will be explained in detail, resolving any doubts at that time. Regular intranatal support The participants in the control group will not be identified as pregnant women with fear of childbirth, and will receive the usual care in the obstetric-gynecological emergency area. Specific intervention for fear of childbirth Online prenatal specific education Online education intervention Participants randomly assigned to the experimental group will be informed by telephone call of their inclusion in the first phase of the trial. Participants in the intervention group will be encouraged to attend routine consultations with their midwife and obstetrician, as well as to take advantage of the group maternal education that participants usually develop in their health center. Specific intranatal support An experimental group will be carried out with a specific support intervention in the obstetric-gynecological emergency area that will supplement the one usually provided to all pregnant women. At the end of the participant's stay within the emergency area due to hospital discharge, admission to the ward, or the end of the pregnancy, the collaborating midwife will fill out an online form designed to monitor the care offered. Said form will also be completed at the end of the work shift if the participant's care continues.
- Primary Outcome Measures
Name Time Method Neonatal outcomes of childbirth 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method Description of obstetrics data of the participants in the recruitment for the trial. At 20-24 weeks gestation Description of obstetrics data of the participants in the sample collection for the trial. The data of all women who fill out the online form in the second trimester of pregnancy will be included. It includes the assessment of parity, and the type of completion of their last birth in case of multiparous women
Description of the sociodemographic data of the participants in the recruitment for the trial.. At 20-24 weeks gestation Description of sociodemographic data of the participants in the sample collection for the trial. The data of all women who fill out the online form in the second trimester of pregnancy will be included.
Description of the birthing preferences of the participants in the recruitment for the trial. At 20-24 weeks gestation Description of birthing preferences of the participants in the sample collection for the trial. The data of all women who fill out the online form in the second trimester of pregnancy will be included. The preferred mode of delivery will be evaluated by the question with four answer options: vaginal delivery, probably vaginal delivery, probably cesarean delivery, or cesarean delivery. Thinking about place to give birth will be evaluated with response options: public hospital, private clinic, or home.
Description of the previous birth experiences 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 sample collection for the trial. The data of all women who fill out the online form in the second trimester of pregnancy will be included. The previous birthing experience it will be evaluated by the linear scale from 1 (very negative) to 5 (very positive). The satisfaction in previous delivery will be evaluated by choosing a value on a linear scale ranging from 1 (very dissatisfied) to 5 (very satisfied).
Intrapartum intervention performed by midwives During the intrapartum intervention, an average of 6 months To describe the intrapartum interventions performed by the midwives during the individual care of each pregnant woman in the intervention group. After each support the midwives will fill out a form with the following questions: identify the name of the midwife, day, work shift, time that the collaborating midwife contacts the participant, reason for consultation, and procedures performed during their care to reduce the fear of childbirth.
Compare the change in value of fear of part before and after delivery. Before 10 days postpartum Compare the results of measuring fear of childbirth before and after childbirth between the study groups.The value of fear before childbirth will be 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 in 37 weeks of gestation obtained in outcome measure 1. The value of fear after childbirth will be 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 obtained in outcome measure 2. To compare both measurements, the scores obtained will be normalized
Trial Locations
- Locations (1)
Hospital Materno Infantil de Gran Canaria
🇪🇸Las Palmas De Gran Canaria, Las Palmas, Spain