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Intact Cord Placental Delivery vs Delayed Cord Clamping (TTC)

14. juli 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

1979

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Italien
- Vicenza
  - Vicenza, Vicenza, Italien, 36100
    - Ospedale San Bortolo

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Maternal outcome: Postpartum blood loss Tidsramme: 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) Tidsramme: 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 Tidsramme: 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 Tidsramme: 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)

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Maternal outcome: duration of the third stage of labour Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: within 24 hours of birth		within 24 hours of birth

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Azienda ULSS 8 Berica

Efterforskere

Studiestol: Francesca carolo, Aulss 8 Berica

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. april 2026

Primær færdiggørelse (Anslået)

31. juli 2027

Studieafslutning (Anslået)

31. juli 2027

Datoer for studieregistrering

Først indsendt

20. marts 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)