A Bond That Nurtures: Neonatal and Maternal Outcomes of Intact Cord Placental Delivery vs Delayed Cord Clamping
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,979
- 试验地点
- 1
- 主要终点
- Maternal outcome: Postpartum blood loss
研究概览
简要总结
The management of the third stage of labour plays a critical role in neonatal transition. Uninterrupted Intact Cord Clamping (UICC), is a clinical approach where the umbilical cord remains unclamped until the placenta is spontaneously expelled. This method aims to facilitate the maximum physiological transfer of placental blood to the newborn.
While Delayed Cord Clamping (DCC)-typically defined as clamping between 1 and 3 minutes or until pulsations cease-is widely supported by literature for its ability to improve neonatal iron stores and reduce morbidity and mortality without increasing maternal-foetal risk, there is currently a lack of robust evidence regarding the systematic practice of Uninterrupted Intact Cord Clamping (UICC), defined as clamping only after placental delivery. This gap in the literature necessitates a thorough investigation into the potential benefits and safety of UICC.
详细描述
Uninterrupted Intact Cord Clamping (UICC) requires waiting for the placenta to be expelled spontaneously before clamping the umbilical cord; this management of the third stage of labour facilitates the complete physiological transfer of placental blood to the newborn. Several studies have suggested that Delayed Cord Clamping (DCC) increases and improves neonatal blood reserves, ensuring more favourable outcomes in terms of neonatal morbidity and mortality without increasing maternal-foetal risk.
Although there is a wealth of literature on the benefits of DCC at 1-3 minutes, the same cannot be said for UICC; hence the need for a thorough investigation of the subject. The overall aim of the study is to compare maternal and neonatal outcomes between UICC and DCC (3 minutes or until pulsations cease), through a single-centre prospective observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy (≥34+0 weeks of gestation).
- •Spontaneous eutocic vaginal delivery.
- •Healthy newborn with a birth weight of ≥2500 grams (appropriate for gestational age).
- •Informed consent signed by both the patient and her partner.
排除标准
- •Maternal Medical Conditions
- •Chronic or Pregnancy-Induced Hypertensive Disorders: Including chronic hypertension, pre-eclampsia, and HELLP syndrome.
- •Systemic Diseases: Pre-existing autoimmune diseases, significant cardiovascular diseases, or metabolic disorders that may interfere with placental function.
- •Haematological Disorders: Known maternal coagulopathies, severe anaemia (Haemoglobin < 8 g/dL), or other blood dyscrasias.
- •Obstetric Complications and Emergencies
- •Placental Anomalies: Suspected or confirmed placental abruption, placenta previa, or morbidly adherent placenta (accreta/increta/percreta).
- •Acute Intrapartum Complications: Umbilical cord prolapse, suspected chorioamnionitis (intra-amniotic infection), or significant antepartum haemorrhage.
- •Operative or Instrumental Delivery: Any requirement for urgent operative vaginal delivery (vacuum or forceps) or conversion to Emergency Caesarean Section.
- •Pre-existing Risk for PPH: History of severe Postpartum Haemorrhage in previous pregnancies.
- •Neonatal Factors
- •Acute Neonatal Distress: Requirement for immediate neonatal resuscitation at birth that precludes waiting for placental expulsion.
- •Congenital Anomalies: Presence of major congenital malformations or chromosomal abnormalities.
结局指标
主要结局
Maternal outcome: Postpartum blood loss
时间窗: during the immediate postpartum period (0-2 hours)
2-hour postpartum blood loss
Maternal outcome: Incidence of retained placenta requiring manual removal of the placenta (MROP)
时间窗: Within two hours of birth
The rate of retained placenta, defined as the failure of the placenta to be expelled within 30-60 minutes of birth, necessitating Manual Removal of the Placenta (MROP) under anaesthesia
Neonatal outcome: Requirement for phototherapy
时间窗: During the hospital stay (up to 3 days)
Incidence of neonates requiring phototherapy for hyperbilirubinemia
Neonatal outcome: physiological weight loss during the early neonatal period
时间窗: During the hospital stay (up to 3 days)
The study will monitor the neonatal physiological weight loss from birth until hospital discharge to evaluate its correlation with placental transfusion volume
次要结局
- Maternal outcome: duration of the third stage of labour(Within two hours of birth)
- Neonatal outcome: apgar scores at 1, 5, and 10 minutes(within 10 minutes of birth)
- Neonatal outcome: umbilical artery pH at delivery(within 10 minutes of birth)
- Neonatal outcome: neonatal resuscitation and NICU admission rates by placental delivery method(During the hospital stay (up to 3 days))
- Neonatal outcome: haematocrit (Hct) levels at 24 hours of life(within 24 hours of birth)