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Intact Cord Placental Delivery vs Delayed Cord Clamping (TTC)

14. července 2026 aktualizováno: Azienda ULSS 8 Berica

A Bond That Nurtures: Neonatal and Maternal Outcomes of Intact Cord Placental Delivery vs Delayed Cord Clamping

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.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

1979

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Itálie
- Vicenza
  - Vicenza, Vicenza, Itálie, 36100
    - Ospedale San Bortolo

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Dospělý
Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

The target population consists of women at full term, who have had a vaginal delivery, and healthy newborns without perinatal complications. The target population also includes late-preterm infants and those with intrauterine growth restriction (IUGR) who have normal fetal Doppler

Popis

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta
Intact cord placental delivery cohort Infants in the intact cord placental delivery (ICPD) group, with clamping performed following placental expulsion
Delayed cord clamping (DCC) prior to placental expulsion Cohort of infants for whom delayed cord clamping was performed before the expulsion of the placenta, ensuring the standard DCC protocol was maintained. Clamping performed between 60 seconds and 3 minutes after birth or Clamping performed only after the cessation of umbilical cord pulsations, which may extend beyond 3 minutes

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Maternal outcome: Postpartum blood loss Časové okno: during the immediate postpartum period (0-2 hours)	2-hour postpartum blood loss	during the immediate postpartum period (0-2 hours)
Maternal outcome: Incidence of retained placenta requiring manual removal of the placenta (MROP) Časové okno: 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	Within two hours of birth
Neonatal outcome: Requirement for phototherapy Časové okno: During the hospital stay (up to 3 days)	Incidence of neonates requiring phototherapy for hyperbilirubinemia	During the hospital stay (up to 3 days)
Neonatal outcome: physiological weight loss during the early neonatal period Časové okno: 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	During the hospital stay (up to 3 days)

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Maternal outcome: duration of the third stage of labour Časové okno: Within two hours of birth	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	Within two hours of birth
Neonatal outcome: apgar scores at 1, 5, and 10 minutes Časové okno: within 10 minutes of birth	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.	within 10 minutes of birth
Neonatal outcome: umbilical artery pH at delivery Časové okno: within 10 minutes of birth	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	within 10 minutes of birth
Neonatal outcome: neonatal resuscitation and NICU admission rates by placental delivery method Časové okno: During the hospital stay (up to 3 days)	The study assesses the need for neonatal resuscitation and NICU admission, with the primary clinical variable being intact cord placental delivery versus standard clamping	During the hospital stay (up to 3 days)
Neonatal outcome: haematocrit (Hct) levels at 24 hours of life Časové okno: within 24 hours of birth		within 24 hours of birth

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Azienda ULSS 8 Berica

Vyšetřovatelé

Studijní židle: Francesca carolo, Aulss 8 Berica

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. dubna 2026

Primární dokončení (Odhadovaný)

31. července 2027

Dokončení studie (Odhadovaný)

31. července 2027

Termíny zápisu do studia

První předloženo

20. března 2026

První předloženo, které splnilo kritéria kontroly kvality

14. července 2026

První zveřejněno (Aktuální)

20. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)