"The Effect of the Cord Clamping Bundle at Birth Developed With the Delphi Method on Maternal and Newborn Outcomes"

Обзор

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.

Подробное описание

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

Вмешательства

• Другое Cord Clamping Bundle
  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.
• Другое Routine Cord Clamping Care
  Routine umbilical cord clamping and postpartum care provided according to the hospital's standard clinical practice without implementation of the cord clamping bundle.

Первичные конечные точки

• Mother-Infant Bonding [Срок оценки: First 24 hours after birth]

Вторичные конечные точки (1)

• Mother-Infant Bonding [Срок оценки: First 24 hours after birth]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Qiu J, Zhou XG, Zhou XY, Zhu C, Shi CM, Ji CB, Cheng R, Li Y, Guo XR. Characterization of microRNA expression profiles in 3T3-L1 adipocytes overexpressing C10orf116. Mol Biol Rep. 2013 Nov;40(11):6469-76. doi: 10.1007/s11033-013-2762-5. Epub 2013 Sep 20. PMID 24052233

Идентификаторы

NCT: NCT07701434 · CSCH-2025-290

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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