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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,979
Ospedale San Bortolo
Vicenza, Vicenza, Italy
Maternal outcome: Postpartum blood loss
2-hour postpartum blood loss
Time frame: during the immediate postpartum period (0-2 hours)
Maternal outcome: Incidence of retained placenta requiring manual removal of the placenta (MROP)
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
Time frame: Within two hours of birth
Neonatal outcome: Requirement for phototherapy
Incidence of neonates requiring phototherapy for hyperbilirubinemia
Time frame: During the hospital stay (up to 3 days)
Neonatal outcome: physiological weight loss during the early neonatal period
The study will monitor the neonatal physiological weight loss from birth until hospital discharge to evaluate its correlation with placental transfusion volume
Time frame: During the hospital stay (up to 3 days)
Maternal outcome: duration of the third stage of labour
This maternal outcome will be the time from neonatal birth to placental expulsion, comparing the efficiency of the third stage between the two study groups
Time frame: Within two hours of birth
Neonatal outcome: apgar scores at 1, 5, and 10 minutes
Secondary neonatal outcomes include the assessment of Apgar scores at 1, 5, and 10 minutes to evaluate the immediate clinical status and transition of the newborn, higher values indicate superior neonatal clinical status.
Time frame: within 10 minutes of birth
Neonatal outcome: umbilical artery pH at delivery
Secondary neonatal outcomes include the assessment of arterial cord blood pH at birth to evaluate the metabolic status and the quality of the transition to extrauterine life
Time frame: within 10 minutes of birth
Neonatal outcome: neonatal resuscitation and NICU admission rates by placental delivery method
The study assesses the need for neonatal resuscitation and NICU admission, with the primary clinical variable being intact cord placental delivery versus standard clamping
Time frame: During the hospital stay (up to 3 days)
Neonatal outcome: haematocrit (Hct) levels at 24 hours of life
Time frame: within 24 hours of birth
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