NCT05955053

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

June 14, 2023

Last Update Submit

February 2, 2024

Conditions

Keywords

Childbirth satisfactionMidwife-pregnant partnershipMidwife-pregnant cooperationChildbirth experiencePartnership modelMidwiferyChildbirthDeliveryCareRandomized

Outcome Measures

Primary Outcomes (2)

  • Childbirth Experience

    In order to determine the birth experiences of women, the birth experience scale score averages of the pregnant women in the experimental and control groups will be compared. The scale consists of 22 items. The lowest score to be taken from the scale is 22, and the highest score is 88. A high birth experience scale score indicates that the mother had a good birth experience. In this context, at the end of the study, the birth experience scale score averages of both groups will be examined in order to evaluate the birth experience.

    12 hours after childbirth

  • Childbirth Satisfaction

    In order to determine the birth satisfaction of the women, the mean birth satisfaction scale scores of the pregnant women in the experimental and control groups will be compared. The scale consists of 30 items. The lowest score to be taken from the scale is 30 and the highest score is 150. A high birth satisfaction scale score indicates a high mother's birth satisfaction. In this context, at the end of the study, the mean birth satisfaction scale scores of both groups will be examined in order to evaluate birth satisfaction.

    12 hours after childbirth

Study Arms (2)

Midwifery care applied in line with Midwife-Pregnant cooperation

EXPERIMENTAL

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

Other: Midwifery care applied in line with Midwife-Pregnant cooperation

Control group

NO INTERVENTION

The group with routine hospital protocol

Interventions

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.

Midwifery care applied in line with Midwife-Pregnant cooperation

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munzur University

Tunceli, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26597110BACKGROUND
  • 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.

    PMID: 9856020BACKGROUND
  • 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.

    PMID: 9515602BACKGROUND

Central Study Contacts

Habibe YAŞAR YETİŞMİŞ, Master

CONTACT

Esin ÇEBER TURFAN, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Paralel designed randomized two armed study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant, Phd Student

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 21, 2023

Study Start

May 1, 2023

Primary Completion

January 30, 2024

Study Completion

May 1, 2024

Last Updated

February 5, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

I can share in case a meta analysis is done

Locations