Clinical trial NCT05000203: Intervention by Midwife to Address the Fear of Childbirth
Official title: Randomized Controlled Trial Comparing a Specific Intervention by Midwife to Address the Fear of Childbirth.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear of Childbirth
Keywords: Fear
Childbirth
Midwifery
Education
Support
Lead sponsor: University of Las Palmas de Gran Canaria
Sponsor class: OTHER
Collaborators: name: Servicio Canario de Salud
First posted: 2021-08-11
Enrollment: 214
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* 20-24 weeks of gestation
* Fear of childbirth
* Normal morphological ultrasound.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in the value of fear of childbirth
timeFrame: At 20-24 and 37 weeks gestation
measure: Value of fear of postnatal childbirth
timeFrame: Before 10 days postpartum
measure: Postpartum maternal satisfaction
timeFrame: Before 10 days postpartum
measure: Obstetric outcomes of childbirth
timeFrame: Before 10 days postpartum
measure: Neonatal outcomes of childbirth
timeFrame: Before 10 days postpartum
Secondary outcomes:
measure: Description of the sociodemographic data of the participants in the recruitment for the trial..
timeFrame: At 20-24 weeks gestation
measure: Description of obstetrics data of the participants in the recruitment for the trial.
timeFrame: At 20-24 weeks gestation
measure: Description of the birthing preferences of the participants in the recruitment for the trial.
timeFrame: At 20-24 weeks gestation
measure: Description of the previous birth experiences of the participants in the recruitment for the trial.
timeFrame: At 20-24 weeks gestation
measure: Compare the change in value of fear of part before and after delivery.
timeFrame: Before 10 days postpartum
measure: Intrapartum intervention performed by midwives
timeFrame: During the intrapartum intervention, an average of 6 months
Other outcomes:
measure: Prenatal education received childbirth.
timeFrame: At 37 weeks gestation
measure: Experience of the midwives before the start of the intervention
timeFrame: For 30 days
Locations:
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Materno Infantil de Gran Canaria
state: Las Palmas
Study officials:
affiliation: Matrona asistencial del área del paritorio del Hospital Materno Infantil de Gran Canaria
name: Sergio Mies Padilla, Matrona
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.