Clinical trial NCT06020339: The Effect of the Continuous Midwifery Care Model on Birth Outcomes
Official title: The Effect of the Education Given to Primiparous Pregnant Women Within the Framework of the Continuous Midwifery Care Model on Their Fears of Birth, Birth Preferences and Postpartum Trauma Perceptions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth, First
Pregnancy Related
Newborn; Fit
Trauma, Psychological
Birth Trauma
Keywords: birth
midwifery care model
birth trauma
post traumatic stress disorder
pregnancy education
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 87
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled longitudinal study. Within the framework of the prenatal continuous midwifery care model, pregnant women who will participate in four modules of training will form the study (education) group and those who do not will form the control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is the right of both the mother and her baby to receive the best care and give birth in the best way possible for every pregnant woman. World Health Organization midwife; It defines a person trained to provide necessary care and counseling during pregnancy, at birth and after birth, to have normal births under his own responsibility, to care for the newborn and to provide family planning counseling. According to the Ministry of Health, the midwife provides these services as well as immunization, protection from infectious and social diseases, etc. He is a healthcare professional who fulfills his roles.

However, in our country, pregnancy, birth and postpartum care services are primarily carried out under the control of a physician, and most of them include medical follow-up. The routine care given by midwives to pregnant women during pregnancy is unfortunately limited to performing the procedures and cannot adequately meet the needs of the woman. As a result, cesarean section rates in our country have risen well above the acceptable level by WHO. Studies have shown that the rate of cesarean section increases with the number of pregnant women who apply to the doctor for pregnancy control. Turkey is the country with the highest cesarean section rates among OECD countries. According to the 2018 results of the Turkey Demographic and Health Survey (TNSA), the rate of cesarean section in our country is 52%. The World Health Organization (WHO) recommended 10-15% cesarean section rate in terms of maternal and infant health in 1985, and re-evaluated this recommendation in 2015. Women who have had a cesarean delivery have greater risks compared to women who have had a vaginal delivery. One of the most common complications after cesarean section is sepsis, and maternal mortality rates increase due to complications such as bleeding and infection after cesarean section. In addition, the choice of cesarean section, which negatively affects many variables such as epigenetically transmitted fear of birth and traumatic birth perception, breastfeeding and microbiota of the baby, is an important factor that will affect future generations. Cesarean section rates, which also cause high maternal and neonatal complication rates, have become a problem that increases health expenditures economically all over the world.

However, cesarean section rates are decreasing in countries where midwives play an active role in pregnancy follow-up. In the midwife-led continuous care model (MLCC), which is carried out by midwives, especially in countries with high normal birth rates, care is completely woman-centered. The model advocates vaginal delivery, which is the most superior form of delivery for maternal and infant health. Studies show that midwife-led continuous care increases vaginal birth rates, women experience a more positive birth, and reduces many unnecessary medical interventions. Within the scope of this care model, midwives train pregnant women from the beginning of pregnancy to the postpartum period and minimize their fear of childbirth based on the fear of the unknown. Another advantage of MLCC is that care will be given by the same midwife or midwife group. This ensures a good bond and uninterrupted communication between the woman and her midwife. This maintenance model is not yet used in our country. The study to be carried out with this training process planned within the scope of MLCC is unique in that it will be carried out for the first time at the national level.

The aim of the study is to evaluate the effect of training to be given with MLCC in reducing cesarean section preferences.

Detailed description: The project has a unique value for a sustainable future in terms of the fear of birth, birth preference, birth perceptions of pregnant women in particular, and its effects at the social level in general. Another unique value is that it is a longitudinal study that uses innovative methods to be taken at the national level to quickly compensate for the acceleration lost in normal birth rates, especially during the pandemic process.

If this research is completed successfully, the researcher will have broken a new ground nationally. This success will contribute to the academic career and prestige of the researcher. The researcher plans to carry out ELSBM trainings, which she plans to start with a motto that supports vaginal birth, in special groups such as immigrant women, women with risky pregnancies, and in cooperation with different institutions in wider masses. As a result of the research, pregnant women participating in the research will receive qualified pregnancy and postpartum care. It is thought that this situation will increase the satisfaction of pregnant women with the institution and increase their preference for vaginal delivery. Thus, it is thought that it will contribute to the reduction of cesarean delivery rates, which have become a worldwide problem, cause high maternal and neonatal complication rates, and increase health expenditures economically.

The study was planned to be conducted with 80 pregnant women (experimental group 40-control group 40) in a randomized controlled manner. G\*Power analysis was used to determine the sample size. In this study, it is planned to provide 4 modules of training to primiparous pregnant women within the framework of the midwife-led continuous care model (MLCC). The first 2 modules of the training to be given in the research were planned to be face-to-face training, the 3rd module as video-conference, and the 4th module as face-to-face training in the postpartum period.

If MLCC is integrated into the health care system, every mother will receive the quality care and education she deserves. This situation will reduce the fear of childbirth experienced by women and the perception of traumatic birth, and will direct women to vaginal birth. Vaginal delivery, which is superior in terms of both maternal and newborn health, has a lower cost compared to cesarean section. Thus, it is thought that MLCC, which will be a cost-effective care model within the scope of health services, will also benefit the country's economy.

Eligibility criteria: Inclusion Criteria:

* Pregnant women who have completed at least primary education,
* Able to speak, understand and write Turkish,
* Pregnant women between the ages of 18-35 (pregnant women under 18 and over 35 years of age will not be preferred since they are among the risky groups in terms of maternal and fetal)
* Pregnant women residing within the borders of Mersin-Tarsus
* Primigravidas (It is planned to include primigravidas in the study, considering that there may be different variables affecting the fear of childbirth in previous pregnancies of multiparas.)
* Pregnant women who do not have any obstacles to give vaginal birth
* Pregnant women with a single and healthy fetus will be included in the study.

Exclusion Criteria:

* Pregnant women with any risky pregnancy history (preeclampsia, placenta previa, gestational diabetes mellitus, oligohydramnios and polyhydramnios, etc.),
* Pregnant women with systemic and/or neurological disease,
* Pregnant women with cesarean indication,
* Pregnant women with chronic and/or psychiatric health problems (based on self-report and clinical diagnosis),
* Pregnant women who participated in any childbirth preparation training program

Primary outcomes:
measure: Personal Information Form
timeFrame: through study completion, an average of 1 year
measure: VIJMA Birth expectation/experience Scale Version A
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Wijma Birth Expectation/Experience Scale B Version (Appendix-3)
timeFrame: through study completion, an average of 1 year
measure: Birth-Related Trauma Perception Scale
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Tarsus University
Study officials:
affiliation: Tarsus University
name: Özlem KOÇ
role: STUDY_CHAIR
References: