Intact Cord Placental Delivery vs Delayed Cord Clamping (TTC)
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.
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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Vicenza
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Vicenza, Vicenza, Italien, 36100
- Ospedale San Bortolo
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Intact cord placental delivery cohort
Infants in the intact cord placental delivery (ICPD) group, with clamping performed following placental expulsion
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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
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Maternal outcome: Postpartum blood loss
Zeitfenster: during the immediate postpartum period (0-2 hours)
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2-hour postpartum blood loss
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during the immediate postpartum period (0-2 hours)
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Maternal outcome: Incidence of retained placenta requiring manual removal of the placenta (MROP)
Zeitfenster: Within two hours of birth
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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
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Within two hours of birth
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Neonatal outcome: Requirement for phototherapy
Zeitfenster: During the hospital stay (up to 3 days)
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Incidence of neonates requiring phototherapy for hyperbilirubinemia
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During the hospital stay (up to 3 days)
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Neonatal outcome: physiological weight loss during the early neonatal period
Zeitfenster: During the hospital stay (up to 3 days)
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The study will monitor the neonatal physiological weight loss from birth until hospital discharge to evaluate its correlation with placental transfusion volume
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During the hospital stay (up to 3 days)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Maternal outcome: duration of the third stage of labour
Zeitfenster: Within two hours of birth
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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
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Within two hours of birth
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Neonatal outcome: apgar scores at 1, 5, and 10 minutes
Zeitfenster: within 10 minutes of birth
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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.
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within 10 minutes of birth
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Neonatal outcome: umbilical artery pH at delivery
Zeitfenster: within 10 minutes of birth
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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
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within 10 minutes of birth
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Neonatal outcome: neonatal resuscitation and NICU admission rates by placental delivery method
Zeitfenster: During the hospital stay (up to 3 days)
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The study assesses the need for neonatal resuscitation and NICU admission, with the primary clinical variable being intact cord placental delivery versus standard clamping
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During the hospital stay (up to 3 days)
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Neonatal outcome: haematocrit (Hct) levels at 24 hours of life
Zeitfenster: within 24 hours of birth
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within 24 hours of birth
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienstuhl: Francesca carolo, Aulss 8 Berica
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- BPM 3
- COMITATO ETICO TERRITORIALE (Andere Kennung: COMITATO ETICO TERRITORIALE AREA SUD OVEST VENETO)
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