NCT07831785

Brief Summary

This randomized controlled trial aims to evaluate the effects of structured supportive midwifery care provided during labor on childbirth satisfaction, breastfeeding success, breastfeeding self-efficacy, and perceived stress among Syrian migrant women. A total of 100 eligible women admitted to the delivery unit of Yuregir State Hospital in Adana, Türkiye, will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Women in the intervention group will receive structured supportive midwifery care in addition to routine hospital care, whereas women in the control group will receive routine maternity care. The supportive care intervention will include physical support, emotional support, informational and communication support, and advocacy throughout labor. Outcomes will be assessed using validated measurement tools during the childbirth and early postpartum periods.

Trial Health

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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress2%
Oct 2026Mar 2027

First Submitted

Initial submission to the registry

September 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

September 15, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

Supportive Midwifery CareSyrian Migrant WomenChildbirth SatisfactionBreastfeeding Self-EfficacyBreastfeeding SuccessPerceived StressLabor Support

Outcome Measures

Primary Outcomes (1)

  • Childbirth Satisfaction

    Childbirth satisfaction will be assessed using the Mackey Childbirth Satisfaction Rating Scale (MCSRS). The scale consists of 34 items rated on a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). The total score ranges from 34 to 170, with higher scores indicating greater satisfaction with the childbirth experience.

    At 24 hours postpartum

Study Arms (2)

Structured Supportive Midwifery Care

EXPERIMENTAL

Participants assigned to this arm will receive structured supportive midwifery care provided by the researcher midwife throughout labor in addition to routine hospital care. Supportive care includes physical support, emotional support, informational and communication support, and advocacy.

Behavioral: Structured Supportive Midwifery Care

Routine Care

ACTIVE COMPARATOR

Participants assigned to this arm will receive the routine labor and postpartum care provided by Yuregir State Hospital. No additional structured supportive midwifery care will be provided by the researcher.

Behavioral: Structured Supportive Midwifery Care

Interventions

Structured supportive midwifery care will be provided by the researcher midwife throughout labor in addition to routine hospital care. The intervention consists of four components: physical support, emotional support, informational and communication support, and advocacy. Physical support includes mobilization, position changes, breathing and relaxation techniques, massage, sacral pressure, touch, and comfort measures according to the woman's needs. Emotional support includes continuous presence, reassurance, encouragement, empathetic communication, and respect for privacy. Informational and communication support includes explanations about the labor process and procedures, guidance on breathing and pushing techniques, and early postpartum and breastfeeding education. Advocacy includes supporting the woman's preferences, participation in decision-making, privacy, and communication with healthcare professionals.

Routine CareStructured Supportive Midwifery Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Syrian migrant women admitted to the Delivery Unit of Adana Yüreğir State Hospital due to labor.
  • Aged 18 years or older.
  • Gestational age between 37 and 42 weeks.
  • Singleton, live pregnancy.
  • Fetus in cephalic presentation.
  • Spontaneous vaginal labor initiated and in the active phase of labor.
  • Able to communicate in Arabic or Turkish at a level sufficient to understand the data collection instruments and the intervention to be applied.
  • Voluntarily agreeing to participate in the study and providing informed consent.

You may not qualify if:

  • Having a planned (elective) cesarean delivery decision at the time of admission.
  • Having an obstetric condition contraindicating vaginal delivery.
  • Having a high-risk pregnancy or labor condition, including severe preeclampsia, eclampsia, placenta previa, or placental abruption.
  • Multiple pregnancy.
  • Intrauterine fetal death or a major fetal anomaly incompatible with life.
  • Having a maternal or fetal clinical condition requiring emergency obstetric intervention at the time of admission for labor.
  • Having a cognitive impairment or severe psychiatric condition that would prevent participation, communication, or the informed consent process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana Yuregir State Hospital

Adana, Turkey (Türkiye)

Location

Study Officials

  • Özlem KOÇ

    Tarsus University, Faculty of Health Sciences, Department of Midwifery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Özlem KOÇ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be blinded to group assignment. They will be informed that two different care approaches are being compared but will not be informed which group is designated as the intervention or control group or about the main study hypotheses. Due to the nature of the supportive care intervention, the researcher providing the intervention cannot be blinded to group assignment.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to two parallel groups. The intervention group will receive structured supportive midwifery care in addition to routine hospital care, while the control group will receive routine hospital care only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2026

First Posted

September 21, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared.

Locations