NCT05000203

Intervention by Midwife to Address the Fear of Childbirth

Randomized Controlled Trial Comparing a Specific Intervention by Midwife to Address the Fear of Childbirth.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: University of Las Palmas de Gran Canaria · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fear of Childbirth

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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
BEHAVIORAL	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.
BEHAVIORAL	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 .

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-11-01
• Completion: 2023-05-08
• First posted: 2021-08-11
• Last updated: 2024-10-18

Locations

1 site across 1 country: Spain