The Effect of the Continuous Midwifery Care Model on Birth Outcomes

NCT ID: NCT06020339

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Birth, First Pregnancy Related Newborn; Fit Trauma, Psychological Birth Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
The sample of the study will consist of 80 pregnant women (40 Study Group: trained, 40 Control Group: not trained), who applied to the hospital between the dates of the study, who met the inclusion criteria and accepted to participate voluntarily in the study. The sample of the first 40 pregnant women to be included in the study (20 study-20 control) will be formed in the first 1st and 3rd month of the research, and the creation of the second sample of 40 pregnant women (20 study-20 control) will be done in the 12th and 13th months of the research.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Randomization group

Pregnant women in the study group will be given a total of 4 modules, 3 modules during pregnancy and 1 module in the postpartum period;

* 1\. module 20-28. During pregnancy weeks, trainings are in the form of face-to-face group training,
* 2\. module 29-36. During pregnancy weeks, trainings are in the form of face-to-face group training,
* 3\. module trainings 37-40. in the form of video-conference (zoom meeting) during pregnancy weeks,
* 4\. module will be applied in 1 month postpartum with face-to-face interview technique).

Pregnancy 20-28. Pregnant women between weeks 29-36 should attend the 1st module education. 2nd module training in gestational weeks, 37-40. They will be trained in the 3rd module during the pregnancy weeks.

module training will be individualized during the mother's visit in the 1st month postpartum.

Version B (WDEQ) will be administered after the program is completed, and the Birth-Related Trauma Perception Scale will be administered after birth.

Group Type EXPERIMENTAL

The midwife-led continuous care model (MLCC)

Intervention Type OTHER

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.

Control group

Pregnant women who will be included in the control group will receive routine midwifery care. In the postpartum period (WDEQ), version B and the Birth Trauma Perception Scale will be used.

The pregnant women will inform the researcher by telephone after the birth (within the first 24 hours) and the mother will be visited by the researcher within the first month after the birth, and the trauma perceptions of the mothers will be evaluated with the Birth Trauma Perception Scale.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Midwife-Led Care

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tarsus University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Özlem KOÇ

Educational Institution

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Özlem KOÇ

Role: STUDY_CHAIR

Tarsus University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tarsus University

Mersin, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

suleozlem2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.