ClinicalTrials.gg
RecruitingNCT05955053Updated Feb 5, 2024

Childbirth Performed in Collaboration With Midwife-Pregnant

An interventional study of Midwifery care applied in line with Midwife-Pregnant cooperation in Birth, First, Care Pattern, Maternal and Care, sponsored by Munzur University. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-05.

Sponsored by Munzur University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Birth, First
  • Care Pattern, Maternal
  • Care
  • Pregnancy Related

Keywords

  • Childbirth satisfaction
  • Midwife-pregnant partnership
  • Midwife-pregnant cooperation
  • Childbirth experience
  • Partnership model
  • Midwifery
  • Childbirth
  • Delivery
  • Care
  • Randomized
03

In context

Lead sponsor

Munzur University is the lead sponsor of 10 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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,
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
154 participants (estimated)

Study arms

  • Experimental
    Midwifery care applied in line with Midwife-Pregnant cooperation

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

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

  • No intervention
    Control group

    The group with routine hospital protocol

Interventions

  • OtherMidwifery 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 hours after childbirth

  2. 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.

    Time frame: 12 hours after childbirth

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 26597110 ↗
  • 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. PubMed 9856020 ↗
  • 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. PubMed 9515602 ↗

Individual participant data

Plan to share: No — I can share in case a meta analysis is done

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2023 (actual). Primary completion is estimated for Jan 2024, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2023
First posted
Jul 21, 2023
StartActual
May 1, 2023
Primary completionEst.
Jan 30, 2024
CompletionEst.
May 1, 2024
Last update
Feb 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05955053
Lead sponsor
Munzur University
Responsible party
Habibe YAŞAR YETİŞMİŞ (Research assistant, Phd Student, Munzur University) — Principal investigator
First posted
Jul 21, 2023
Start date
May 1, 2023
Primary completion
Jan 30, 2024 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Feb 5, 2024

Study contacts

Habibe YAŞAR YETİŞMİŞ, Master
Contact
habibeyasar@munzur.edu.tr
+90 213 17 94
Esin ÇEBER TURFAN, Phd
Contact
esin.ceber@ege.edu.tr
+90 232 311 33 79

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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