Fear of ChildbirthNCT05000203
Intervention by Midwife to Address the Fear of Childbirth
A study testing Online prenatal specific education, Intrapartum specific support and Prenatal usual education in people with Fear of Childbirth, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fear of Childbirth
- What is being tested?
- Online prenatal specific education, Intrapartum specific support and Prenatal usual education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 8 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- 20-24 weeks of gestation
- Fear of childbirth
- Normal morphological ultrasound.
Who cannot join
- Online questionnaire disability
- Videoconference disability
- Incomplete questionnaires
- Language barrier.
- Withdrawal criteria:
- Elective caesarean section
Show all 11Show fewer
- Delivery before 37 weeks of gestation
- Non-attendance at educational sessions
- Delivery in a place other than HUMIC
- Fetal death
- Decline of informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016
About this study
Official title: Randomized Controlled Trial Comparing a Specific Intervention by Midwife to Address the Fear of Childbirth.
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.
Read the 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.
- Conditions
- Fear of Childbirth
- Being tested
- Online prenatal specific education, Intrapartum specific support, Prenatal usual education, Intrapartum usual support
- Keywords
- Fear, Childbirth, Midwifery, Education, Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online prenatal specific educationBehavioural
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 supportBehavioural
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 educationBehavioural
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 supportBehavioural
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 .
| Study group | Role | What they receive |
|---|---|---|
| Specific intervention for fear of childbirth | Experimental | 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. Receives: Behavioral: Online prenatal specific education; Behavioral: Intrapartum specific support |
| Routine intervention for fear of childbirth | Active comparator | 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. Receives: Behavioral: Prenatal usual education; Behavioral: Intrapartum usual support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the value of fear of childbirth
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.
Measured: At 20-24 and 37 weeks gestation
Value of fear of postnatal childbirth
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.
Measured: Before 10 days postpartum
Postpartum maternal satisfaction
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.
Measured: Before 10 days postpartum
Obstetric outcomes of childbirth
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
Measured: Before 10 days postpartum
Neonatal outcomes of childbirth
Describe and compare the following neonatal outcomes of childbirth between both study groups
Measured: Before 10 days postpartum
Secondary outcomes (6)
Description of the sociodemographic data of the participants in the recruitment for the trial..
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.
Measured: At 20-24 weeks gestation
Description of obstetrics data of the participants in the recruitment for the trial.
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
Measured: At 20-24 weeks gestation
Description of the birthing preferences of the participants in the recruitment for the trial.
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.
Measured: At 20-24 weeks gestation
Description of the previous birth experiences of the participants in the recruitment for the trial.
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).
Measured: At 20-24 weeks gestation
Compare the change in value of fear of part before and after delivery.
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
Measured: Before 10 days postpartum
Intrapartum intervention performed by midwives
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.
Measured: During the intrapartum intervention, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start1 Jun 2021
- Primary completion1 Nov 2022
- Study completion8 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Las Palmas de Gran Canaria
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio Canario de Salud
- Responsible party
- Principal investigator, Sergio Mies Padilla, University of Las Palmas de Gran Canaria
- Investigators
- Sergio Mies Padilla, Matrona, Principal investigator, Matrona asistencial del área del paritorio del Hospital Materno Infantil de Gran Canaria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000203
- Sponsor's protocol ID
- Código CEIm HUGCDN: 2021-169-1
- Status last verified
- Oct 2024
- First submitted
- 8 Jul 2021
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned to share the training plan of the online sessions
Publications
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.
PubMed 39103313
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing a Specific Intervention by Midwife to Address the Fear of Childbirth.
- ClinicalTrials.gov ID
- NCT05000203
- Acronym / sponsor ID
- Código CEIm HUGCDN: 2021-169-1
- Conditions
- Fear of Childbirth
- Keywords
- Fear, Childbirth, Midwifery, Education, Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of Las Palmas de Gran CanariaUniversity, hospital or other
- Collaborators
- Servicio Canario de Salud
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific intervention for fear of childbirth | Experimental | Behavioral: Online prenatal specific education, Behavioral: Intrapartum specific supportOnline 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 | Active comparator | Behavioral: Prenatal usual education, Behavioral: Intrapartum usual supportUsual 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age
- 20-24 weeks of gestation
- Fear of childbirth
- Normal morphological ultrasound.
Key exclusion criteria (11 listed)
- Online questionnaire disability
- Videoconference disability
- Incomplete questionnaires
- Language barrier.
- Elective caesarean section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online prenatal specific educationThe 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. | Behavioural | Specific intervention for fear of childbirth |
| Intrapartum specific supportAt 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 | Behavioural | Specific intervention for fear of childbirth |
| Prenatal usual educationThe 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. | Behavioural | Routine intervention for fear of childbirth |
| Intrapartum usual supportA 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 . | Behavioural | Routine intervention for fear of childbirth |
Primary outcome
Change in the value of fear of childbirth
Time frame: 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.
Value of fear of postnatal childbirth
Time frame: 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.
Postpartum maternal satisfaction
Time frame: 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.
Obstetric outcomes of childbirth
Time frame: 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
Neonatal outcomes of childbirth
Time frame: Before 10 days postpartum
Describe and compare the following neonatal outcomes of childbirth between both study groups
6 secondary outcomes
Description of the sociodemographic data of the participants in the recruitment for the trial..
Time frame: At 20-24 weeks gestation
Description of obstetrics data of the participants in the recruitment for the trial.
Time frame: At 20-24 weeks gestation
Description of the birthing preferences of the participants in the recruitment for the trial.
Time frame: At 20-24 weeks gestation
Description of the previous birth experiences of the participants in the recruitment for the trial.
Time frame: At 20-24 weeks gestation
Compare the change in value of fear of part before and after delivery.
Time frame: Before 10 days postpartum
Intrapartum intervention performed by midwives
Time frame: During the intrapartum intervention, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Results publication: PubMed 39103313Mies 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.
- Individual participant dataSharing planned: Yes. It is planned to share the training plan of the online sessions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergio Mies Padilla, Matrona principal investigator
Matrona asistencial del área del paritorio del Hospital Materno Infantil de Gran Canaria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online prenatal specific education, Intrapartum specific support and Prenatal usual education in people with Fear of Childbirth, run by University of Las Palmas de Gran Canaria at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the value of fear of childbirth (time frame: At 20-24 and 37 weeks gestation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05000203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.