Clinical trial NCT06624748: Companions Who Support the Pregnant Woman During the Birth Process
Official title: Evaluation of the Opinions of Companions Who Support the Pregnant Woman During the Birth Process: Mixed Method Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childbirth Problems
Support, Family
Keywords: Pregnancy
Midwife
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In our country, although there is currently an emphasis on companion support within the scope of mother-friendly hospitals, there is no guide for companions. This study was planned to determine the effect of women who have companion support during labor on birth satisfaction, birth comfort, postpartum comfort level and positive birth outcomes, as well as the opinions of the people who provide support. Based on the results obtained and the positive contributions to maternal satisfaction during the labor process, birth and postpartum comfort process, mother-baby health, as well as the opinions of the companions, a 'Pregnant Support Guide in Labor' will be created and the companions will be enabled to support the pregnant woman in line with this guide. In addition, based on the opinions of the attendants, the researchers plan to develop the 'Birth Support Satisfaction Scale'.

Detailed description: Type of research The study is a Randomized Controlled Mixed Method study. Research Design This study is a mixed method study planned to be conducted to evaluate the effect of companion support on the labor process and the opinions of companions, using a randomized controlled experimental design and in-depth individual interview method. This clinical trial will be registered at ClinicalTrials.gov. Reporting will be adhered to CONSORT for parallel group randomized studies. (CONSORT 2010, Access date: 10 August 2022). The research is planned to be carried out in the delivery room of Sakarya Training and Research Hospital between 01 March 2023 and 30 December 2024.

Where the Research Will Be Conducted The study will be carried out in the delivery room of Sakarya Training and Research Hospital. Pregnant women who have started labor are admitted to the delivery room by a doctor, and labor follow-up is carried out by midwives and assistant doctors under the supervision of a gynecologist. On average, around 350 vaginal births occur monthly. Since the hospital is not mother-friendly, a companion is not allowed to accompany the pregnant woman in routine practices.

Data Collection Stages The intervention and control groups will be informed about the research, and a personal information form will be applied to pregnant women and their companions who accept it.

Eligibility criteria: Inclusion Criteria:

* Pregnant women aged 37-42.
* Women who are planning to give birth vaginally during their first week of pregnancy.
* First-time pregnant women.
* Women with no vision, hearing, or communication problems.
* Women who can speak and express themselves in Turkish.
* Women who are willing to participate voluntarily in the study.

Exclusion Criteria:

* Pregnant women with multiple pregnancies.
* Women who are planned to give birth by cesarean section.
* Women with any complications during pregnancy.
* Women with chronic diseases.
* Pregnant women with verbal, mental, or other communication disabilities.
* Among the pregnant women included in the control or intervention group, those who:
* Received epidural analgesia.
* Experienced instrumental delivery (with vacuum or forceps).
* Had postnatal complications in the newborn.
* Had complications related to episiotomy (such as 3rd and 4th degree laceration, hematoma).

Primary outcomes:
measure: Birth Comfort Scale Score
timeFrame: At the time of cervical dilatation reaching 8 cm during the intrapartum period
Secondary outcomes:
measure: Postpartum Comfort Scale
timeFrame: Two hours postpartum
Other outcomes:
Locations:
city: Selçuklu
country: Turkey
facility: Bihter Akın
state: Konya
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Selcuk University
name: Bihter Akın
role: STUDY_CHAIR
References: