The Effect of the Continuous Midwifery Care Model on Birth Outcomes

Pregnancy Related Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020339
• Other study ID #: suleozlem2023
• Status: Recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: February 2024

Study information

• Verified date: November 2023
• Source: Tarsus University
• Contact: Özlem KOÇ, Dr
• Phone: +90 0552 083 95 94
• Email: ozlemkoc[@]tarsus.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Birth Injuries
• Birth Trauma
• Birth, First
• Newborn; Fit
• Pregnancy Related
• Psychological Trauma
• Trauma, Psychological
• Wounds and Injuries

Intervention

Other:
• The midwife-led continuous care model (MLCC)
Continuity of midwife-led care has been defined as care in which the midwife is the leading professional in the planning, organization and delivery of care given to a woman from the initial assessment of the pregnant woman to the postpartum period. ELSBM; It is the same midwife or midwife group providing the care and counseling needed by the woman during pregnancy, childbirth and postpartum period. In this care model, the midwife is the leading health care specialist who is responsible for planning and arranging the care given to women in the antenatal, natal and postnatal period. MLCC is woman-centered and is based on the idea that pregnancy and childbirth are normal life events. This care model includes education, counseling and care according to the needs of the woman. It promotes vaginal delivery as a normal process and advocates minimal interventions. Continuity of midwifery-led care is associated with superior outcomes for women and infants than other models of care.

Locations

Country	Name	City	State
Turkey	Tarsus University	Mersin

Sponsors (1)

Lead Sponsor	Collaborator
Tarsus University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personal Information Form	It consists of questions about the sociodemographic characteristics, pregnancy and birth characteristics of the pregnant women who were prepared by the researcher by scanning the relevant literature.	through study completion, an average of 1 year
Primary	VIJMA Birth expectation/experience Scale Version A	In order to determine the fear of childbirth, Wij-ma et al. (1998) developed by. The validity and reliability study of the scale in Turkish was performed by Korukcu et al. (2012) by It is an item scale. The scale has certain breakpoints. These; low-grade fear of childbirth (=37), moderate-grade fear of childbirth (38-65), severe fear of childbirth (66-84), and clinical-grade fear of childbirth (=85). In the validity-reliability study of the scale, the Cronbach Alpha value was found to be 0.89.	through study completion, an average of 1 year
Secondary	Wijma Birth Expectation/Experience Scale B Version (Appendix-3)	The Turkish adaptation of the scale, which was first developed by K. Wijma et al. (2002), was made by Uçar and Beji in 2013. The scale includes fear, confidence, feeling of loneliness, happiness, etc. It consists of 33 questions in total, including feelings and thoughts. Each item is in a 6-point Likert type, scoring between 1 and 6. 1 is expressed as "totally" and 6 as "not at all". While the minimum-candle score is 33 on the scale, the maximum score is 198. High scores indicate that women's fear of childbirth is high. Negatively charged items (2, 3, 6, 7, 8, 11, 12, 15, 19, 20, 24, 25, 27, 31) in the scale are calculated by inverting them in order to ensure consistency in the measurement. In the study conducted by Wijma et al. (1998), Cronbach's alpha values were determined as 0.89 in nulliparas, 0.99 in multiparas and 0.93 in total. In the Turkish version, the Cronbach alpha value of the Wijma Birth Expectation/Experience Scale Version B was found to be 0.88.	through study completion, an average of 1 year
Secondary	Birth-Related Trauma Perception Scale	The Birth Trauma Perception Scale was developed by Mucuk and Ozkan to evaluate mothers' perceptions of trauma associated with vaginal delivery and can be used throughout the country as a valid and reliable measurement tool. The Birth Trauma Perception Scale can be used from the first postpartum week to one year. It is thought that the scale will enable the identification of individuals sensitive to trauma associated with birth, their evaluation in terms of trauma symptoms in the process, and the better quality of individualized midwifery care required in this regard. The scale is in a five-point Likert model. Total scale scores vary between 39-195. An increase in the score obtained from the scale indicates that the woman's perception of trauma is high. In the validity-reliability study of the scale, the Cronbach Alpha value was found to be 0.92.	through study completion, an average of 1 year