- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07831785
Supportive Care During Childbirth in Syrian Migrant Women
Comparison of Childbirth Satisfaction, Breastfeeding Self-Efficacy, and Perceived Stress in Syrian Migrant Women Receiving and Not Receiving Supportive Care During Childbirth
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study is designed as a two-arm, parallel-group, randomized controlled trial. The study population will consist of Syrian migrant women admitted in active labor to the Delivery Unit of Yuregir State Hospital in Adana, Türkiye, who meet the eligibility criteria and provide written informed consent.
A total of 100 participants will be randomized in a 1:1 ratio to the intervention group (n=50) or control group (n=50). A variable block randomization procedure using block sizes of 4 and 6 will be used. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes.
Participants assigned to the intervention group will receive structured supportive midwifery care provided by the researcher midwife throughout labor in addition to routine hospital care. The intervention consists of four main components: physical support, emotional support, informational and communication support, and advocacy. Physical support includes measures such as mobilization, position changes, breathing and relaxation techniques, massage, sacral pressure, touch, and other comfort measures according to the woman's needs. Emotional support includes continuous presence, reassurance, encouragement, empathetic communication, and respect for privacy. Informational support includes explanations about the labor process, procedures, breathing and pushing techniques, and early postpartum and breastfeeding education. Advocacy focuses on supporting women's preferences, participation in decision-making, privacy, and communication with healthcare professionals.
Participants assigned to the control group will receive the routine labor and postpartum care provided by the hospital without the additional structured supportive care intervention delivered by the researcher.
Study outcomes include childbirth satisfaction, breastfeeding success assessed using the LATCH Breastfeeding Assessment Tool, postpartum breastfeeding self-efficacy, and perceived stress. Data will be collected at predefined time points from the beginning of labor through the first 24 hours postpartum.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Özlem KOÇ, PhD
- Telefonnummer: 05520839594
- E-mail: ozlemkoc@tarsus.edu.tr
Studiesteder
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Adana, Tyrkiet (Türkiye)
- Adana Yuregir State Hospital
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Kontakt:
- Fatma KEÇE
- Telefonnummer: +90 05347857596
- E-mail: 254131005@tarsus.edu.tr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Structured Supportive Midwifery Care
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. |
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. |
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Aktiv komparator: Routine Care
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. |
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Childbirth Satisfaction
Tidsramme: At 24 hours postpartum
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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
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Özlem KOÇ, Tarsus University, Faculty of Health Sciences, Department of Midwifery
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- FKECE-RCT-2026-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Individual participant data will not be shared.
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