Intervention by Midwife to Address the Fear of Childbirth
NCT ID: NCT05000203
Last Updated: 2024-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
214 participants
INTERVENTIONAL
2021-06-01
2023-05-08
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Specific intervention for fear of childbirth
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.
Online prenatal specific education
The sessions will start around 30 weeks of gestation with the intention that around 35-37 weeks all pregnant women have had the opportunity to attend all the sessions.
Five specific online group sessions have been established for the fear of childbirth, each divided into three parts, and lasting approximately 60 minutes. In the first part, the aspects that are most relevant according to the reported experience of women with fear of childbirth will be discuss. In a second part, videos will be displayed starring midwives who will collaborate in specific intrapartum support with the aim of presenting the personnel involved in the care of women during delivery and immediate postpartum, and where the procedures and options available in the obstetric service of HUMIC. The session will end with brief therapy tasks. After each session, written documentation on the topics discussed will be made available to the participants.
Intrapartum specific support
At first, a group of expert midwives will be formed in support of pregnant women with fear of childbirth. The objective is that three midwives from each work group shift will include the women from the experimental group in the intrapartum support team. The working group will receive a seminar given by the researcher where the study protocol and an update on fear of childbirth will be explained, which will include information on: concept and prevalence, risk factors, consequences, diagnosis and treatment.
For the follow-up of the participants, an instant messaging group will be formed where the collaborating midwives and the main researcher will be able to find out the existence of a participant within the emergency area or in the maternity ward, facilitating continued care in the changes of guard
Routine intervention for fear of childbirth
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.
Prenatal usual education
The participants in this group will follow the development of the usual interventions by midwives and obstetricians according to the established protocol for monitoring the pregnancy and / or by the private care system, as well as additional consultations for complications in pregnancy or consultations on demand that are considered necessary Group maternal education is offered in primary care center starting at week 28 of gestation. Although its content is supported by the Affective-Sexual and Reproductive Health Care Program, midwives are responsible for preparing the sessions according to their criteria to adapt them to the population. In addition to group interventions, pregnant women in the intervention environment also receive individualized educational attention in follow-up and control visits. After delivery, an inquiry will be made about the maternal education received by pregnant women during their current pregnancy.
Intrapartum usual support
A routine detection of fear of childbirth or a protocolized practice for this problem is currently not contemplated in the trial setting. The different professionals who pay their attention to the pregnant woman can detect the fear of childbirth thanks to their experience or different indicators such as the expression of fears by the pregnant woman, being able to offer individualized attention and resources for the approach, according to their awareness of the problem .
Interventions
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Online prenatal specific education
The sessions will start around 30 weeks of gestation with the intention that around 35-37 weeks all pregnant women have had the opportunity to attend all the sessions.
Five specific online group sessions have been established for the fear of childbirth, each divided into three parts, and lasting approximately 60 minutes. In the first part, the aspects that are most relevant according to the reported experience of women with fear of childbirth will be discuss. In a second part, videos will be displayed starring midwives who will collaborate in specific intrapartum support with the aim of presenting the personnel involved in the care of women during delivery and immediate postpartum, and where the procedures and options available in the obstetric service of HUMIC. The session will end with brief therapy tasks. After each session, written documentation on the topics discussed will be made available to the participants.
Intrapartum specific support
At first, a group of expert midwives will be formed in support of pregnant women with fear of childbirth. The objective is that three midwives from each work group shift will include the women from the experimental group in the intrapartum support team. The working group will receive a seminar given by the researcher where the study protocol and an update on fear of childbirth will be explained, which will include information on: concept and prevalence, risk factors, consequences, diagnosis and treatment.
For the follow-up of the participants, an instant messaging group will be formed where the collaborating midwives and the main researcher will be able to find out the existence of a participant within the emergency area or in the maternity ward, facilitating continued care in the changes of guard
Prenatal usual education
The participants in this group will follow the development of the usual interventions by midwives and obstetricians according to the established protocol for monitoring the pregnancy and / or by the private care system, as well as additional consultations for complications in pregnancy or consultations on demand that are considered necessary Group maternal education is offered in primary care center starting at week 28 of gestation. Although its content is supported by the Affective-Sexual and Reproductive Health Care Program, midwives are responsible for preparing the sessions according to their criteria to adapt them to the population. In addition to group interventions, pregnant women in the intervention environment also receive individualized educational attention in follow-up and control visits. After delivery, an inquiry will be made about the maternal education received by pregnant women during their current pregnancy.
Intrapartum usual support
A routine detection of fear of childbirth or a protocolized practice for this problem is currently not contemplated in the trial setting. The different professionals who pay their attention to the pregnant woman can detect the fear of childbirth thanks to their experience or different indicators such as the expression of fears by the pregnant woman, being able to offer individualized attention and resources for the approach, according to their awareness of the problem .
Eligibility Criteria
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Inclusion Criteria
* 20-24 weeks of gestation
* Fear of childbirth
* Normal morphological ultrasound.
Exclusion Criteria
* 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.
18 Years
FEMALE
Yes
Sponsors
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Servicio Canario de Salud
OTHER
University of Las Palmas de Gran Canaria
OTHER
Responsible Party
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Sergio Mies Padilla
Principal Investigator
Principal Investigators
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Sergio Mies Padilla, Matrona
Role: PRINCIPAL_INVESTIGATOR
Matrona asistencial del área del paritorio del Hospital Materno Infantil de Gran Canaria
Locations
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Hospital Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, Spain
Countries
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References
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Mies Padilla S, Gonzalez de la Torre H, Lopez Alcaide E, Verdu Soriano J, Martin Martinez A. Randomized Controlled Trial of Interventions Used by Midwives to Treat Fear of Childbirth. Nurs Res. 2024 Nov-Dec 01;73(6):E221-E231. doi: 10.1097/NNR.0000000000000756. Epub 2024 Jul 17.
Other Identifiers
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Código CEIm HUGCDN: 2021-169-1
Identifier Type: -
Identifier Source: org_study_id
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