Childbirth Performed in Collaboration With Midwife-Pregnant

NCT ID: NCT05955053

Last Updated: 2024-02-05

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

RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-05-01

Brief Summary

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

With the medicalization of midwifery care; It has been reported that the autonomy of midwives is reduced, and their relationships with care and care recipients are under threat. For this reason, the midwife had to move away from the concept of being with the woman and face the ideology of being with the institution. In this context, it is thought that there is a need for care models that enable the midwife and woman to work in cooperation. It is thought that establishing a collaborative relationship based on the partnership model between the midwife and the pregnant will be possible with the continuity of care. There are studies in the literature showing that the continuity of midwifery care has positive results at birth. However, no study has been found regarding the partnership or cooperation of the midwife with the pregnant woman during delivery with standards. It is thought that this research to be conducted has a unique value in terms of meeting the need for scientific information on the effect of midwife-pregnant cooperation on birth experience and birth satisfaction. In the study, continuous midwifery care will be given to pregnant women during delivery based on midwife-pregnant cooperation in line with the midwifery care model checklist. It is thought that this midwifery care given during birth will positively affect the birth experience and birth satisfaction.

Detailed Description

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

It has been reported that the medical care model has become widespread, the autonomy of midwives has decreased within the scope of medical care, the care is more medical, the relations of the midwife with the care recipients are under threat and holistic care is avoided. Due to the inability to provide one-to-one holistic care to pregnant women, pregnant women perceive their births as traumatic and experience negative births. In this context, the aim of the research is to evaluate the effect of midwife-pregnant cooperation on birth experience and birth satisfaction within the scope of partnership model. A total of 154 (Intervention; 77, Control; 77) people are planned to be included in the research by performing power analysis. Within the scope of the partnership model, one-to-one care will be given to the pregnant woman in the intervention group during delivery, according to the partnership model, and no intervention will be applied to the control group. Voluntary consent will be obtained from the volunteers to be included in the study and will be randomly included in the groups. Pregnant Information Form, Midwife-Pregnant Collaboration Scale at Birth, Birth Experience Scale, Birth Satisfaction Scale and Midwifery Birth Care Model Checklist will be used to collect research data. Number, percentage distribution, mean and standard deviation, correlation/regression test and t-test for independent groups will be used in the analysis of the research. It is thought that with the care given at the end of the research, the birth experience of the pregnant women will be positive and they will be satisfied with the birth. In the research, it is thought that the positive birth experience and satisfaction of the pregnant women will indirectly give a positive perspective to the normal birth.

Conditions

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

Birth, First Care Pattern, Maternal Care Pregnancy Related

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

Paralel designed randomized two armed study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
In this study, in order to minimize the risk of bias, the pregnant women will not know which group they are in, and the statistician will not be informed which group is the intervention and which group is the control during the analysis phase, and the study will be conducted with a blinding method. However, since the person who made the intervention, the researcher (HYY), who took part in the research, is knowledgeable about the intervention and will do the intervention himself, it is not possible to blind the researcher.

Study Groups

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

Midwifery care applied in line with Midwife-Pregnant cooperation

The group that received care in line with the midwifery care model checklist

Group Type EXPERIMENTAL

Midwifery care applied in line with Midwife-Pregnant cooperation

Intervention Type OTHER

Pregnant women who apply to the obstetrics clinic will be informed about the research by the doctor and the pregnant woman whose labor has started will be sent to the delivery room. The researcher will be welcomed by the midwife from the first time the pregnant woman arrives in labor (delivery room), and firstly she will be informed about the purpose of the research and an informative consent form and a pregnant identification form will be filled in that she agrees to participate in the research. During labor and labor, the research midwife (HYY) will be with a pregnant woman until she gives birth and care will be given according to the items in the midwifery care checklist prepared based on the partnership model. After giving birth to a pregnant woman and applying the scales, another pregnant woman will be transferred and care will be given in the same way according to the midwifery care model checklist.

Control group

The group with routine hospital protocol

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.

Midwifery care applied in line with Midwife-Pregnant cooperation

Pregnant women who apply to the obstetrics clinic will be informed about the research by the doctor and the pregnant woman whose labor has started will be sent to the delivery room. The researcher will be welcomed by the midwife from the first time the pregnant woman arrives in labor (delivery room), and firstly she will be informed about the purpose of the research and an informative consent form and a pregnant identification form will be filled in that she agrees to participate in the research. During labor and labor, the research midwife (HYY) will be with a pregnant woman until she gives birth and care will be given according to the items in the midwifery care checklist prepared based on the partnership model. After giving birth to a pregnant woman and applying the scales, another pregnant woman will be transferred and care will be given in the same way according to the midwifery care model checklist.

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Between the ages of 18-35,
* Childbirth started and hospitalized,
* Having a live, single, healthy fetus,
* In the active phase (dilatation= 4 cm and above),
* No maternal and fetal complications that may affect labor,
* At least primary school graduate and no language-communication problem,
* Pregnant women who accepted to participate in the study and whose consent was obtained will be included in the study.

Exclusion Criteria

* Those with a chronic disease,
* Those with multiparous pregnancy,
* Adolescent pregnant women under the age of 18,
* Advanced age pregnant women over 35 years old,
* Being unable to speak Turkish and having communication difficulties,
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.

Munzur University

OTHER

Sponsor Role lead

Responsible Party

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

Habibe YAŞAR YETİŞMİŞ

Research assistant, Phd Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Munzur University

Tunceli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Habibe YAŞAR YETİŞMİŞ, Master

Role: CONTACT

+90 213 17 94

Esin ÇEBER TURFAN, Phd

Role: CONTACT

+90 232 311 33 79

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Habibe YAŞAR YETİŞMİŞ, Master

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Boyle S, Thomas H, Brooks F. Women's views on partnership working with midwives during pregnancy and childbirth. Midwifery. 2016 Jan;32:21-9. doi: 10.1016/j.midw.2015.09.001. Epub 2015 Sep 9.

Reference Type BACKGROUND
PMID: 26597110 (View on PubMed)

Fleming VE. Women-with-midwives-with-women: a model of interdependence. Midwifery. 1998 Sep;14(3):137-43. doi: 10.1016/s0266-6138(98)90028-6.

Reference Type BACKGROUND
PMID: 9856020 (View on PubMed)

Fleming VE. Women and midwives in partnership: a problematic relationship? J Adv Nurs. 1998 Jan;27(1):8-14. doi: 10.1046/j.1365-2648.1998.00474.x.

Reference Type BACKGROUND
PMID: 9515602 (View on PubMed)

Other Identifiers

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

habibe47

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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