"The Effect of the Cord Clamping Bundle at Birth Developed With the Delphi Method on Maternal and Newborn Outcomes" (Cord Clamping)
This clinical trial aims to evaluate the effects of a cord clamping bundle developed through the Delphi method on maternal and neonatal outcomes. The study population consists of primiparous women with singleton term pregnancies (37-42 weeks of gestation) who undergo vaginal delivery, along with their healthy newborns.
The primary research questions are:
Does the Delphi-based cord clamping bundle improve maternal and neonatal physiological outcomes? Does the Delphi-based cord clamping bundle enhance mother-infant bonding and breastfeeding success?
Comparison Group:
Researchers will compare the intervention group, in which the cord clamping bundle is implemented, with the control group receiving routine clinical care to determine the effects of the intervention on maternal and neonatal outcomes.
Participant Involvement:
Participants will provide written and verbal informed consent and complete a personal information form. Following delivery, participants will receive either the cord clamping bundle intervention or routine care according to their assigned group. Data collection will be conducted within the first 24 hours postpartum and will include:
Maternal and neonatal physiological parameters Breastfeeding success assessed using the LATCH Breastfeeding Assessment Tool Mother-infant bonding assessed using the Mother-to-Infant Bonding Scale Amount of postpartum bleeding Placental separation time Time to initiation of breastfeeding Length of hospital stay after delivery.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This study aims to evaluate the effects of a cord clamping bundle developed using the Delphi technique on maternal and neonatal outcomes following term vaginal birth. The bundle was developed based on expert consensus to standardize cord clamping practices during the immediate postpartum period.
The study will be conducted among primiparous women with singleton term pregnancies who undergo vaginal delivery and their healthy newborns. Participants will be assigned to either an intervention group receiving the cord clamping bundle or a control group receiving routine cord clamping care according to hospital practice.
Maternal and neonatal physiological outcomes, breastfeeding success, mother-infant bonding, postpartum bleeding, placental separation time, time to initiation of breastfeeding, and length of hospital stay will be evaluated within the first 24 hours after birth. Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool, and mother-infant bonding will be assessed using the Mother-to-Infant Bonding Scale. The findings are expected to contribute to evidence-based cord clamping practices and improve maternal and neonatal care outcomes.BizChat hakkında geri bildirim gönderin
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Primiparous women Singleton pregnancy Term pregnancy (37-42 weeks of gestation) Vaginal delivery Healthy newborn Mother and newborn discharged together Age 18 years or older Willingness to participate and provide written informed consent
Exclusion Criteria:
High-risk pregnancy Maternal chronic disease Maternal or neonatal conditions affecting breastfeeding Newborn with intrauterine growth restriction (IUGR) Newborn with a genetic disorder or congenital anomaly Operative or assisted vaginal delivery requiring obstetric intervention Refusal to participate or withdrawal from the study Incomplete study data or inability to complete outcome assessments
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Cord Clamping Bundle Group
Experimental Arm (Cord Clamping Bundle Group) Intervention: Delphi-Based Cord Clamping Bundle Participants in this arm will receive the Delphi-based cord clamping bundle. The bundle includes preparation of sterile materials, delayed cord clamping until cord pulsations cease (at least 1-3 minutes), cord clamping with a sterile umbilical clamp, cutting the cord 4-5 cm from the skin using sterile scissors, and maintaining dry cord care. |
A standardized cord clamping bundle developed through the Delphi technique based on expert consensus.
The intervention includes preparation of sterile materials, delayed umbilical cord clamping until cord pulsations cease (at least 1-3 minutes after birth), sterile cord clamping and cutting, and maintenance of dry cord care.
|
|
Aktiv komparator: Routine Cord Clamping Group
Routine umbilical cord clamping and postpartum care provided according to the hospital's standard clinical practice without implementation of the cord clamping bundle.
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Routine umbilical cord clamping and postpartum care provided according to the hospital's standard clinical practice without implementation of the cord clamping bundle.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mother-Infant Bonding
Tidsramme: First 24 hours after birth
|
Mother-infant bonding assessed using the Mother-to-Infant Bonding Scale.
|
First 24 hours after birth
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mother-Infant Bonding
Tidsramme: First 24 hours after birth
|
Mother-infant bonding assessed using the Mother-to-Infant Bonding Scale.
|
First 24 hours after birth
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neonatal Hemoglobin Level (if measured)
Tidsramme: First 24 hours after birth
|
Neonatal hemoglobin concentration. Unit of Measure: g/dL |
First 24 hours after birth
|
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Neonatal Hematocrit Level (if measured)
Tidsramme: First 24 hours after birth
|
Neonatal hematocrit percentage.
Unit of Measure: %
|
First 24 hours after birth
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CSCH-2025-290
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