Intact Cord Placental Delivery vs Delayed Cord Clamping

NCT07713277 | Active Not Recruiting

• 2 other identifiers: BPM 3COMITATO ETICO TERRITORIALE
• Study Type: observational
• Target: 1,979
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intact Cord Placental Delivery; Delayed Cord Clamping; Standard Delayed Cord Clamping; Timing of Cord Clamping; Postpartum Hemorrhage (Primary)

Keywords

ICPD; DCC; Intact Cord Placental Delivery; Delayed Cord Clamping; Third stage of labour; Early Cord Clamping; ECC; Immediate Cord Clamping; ICC; TTC; Very Delayed Clamping; VDC; PPH; Obstetric hemorrhage; Postpartum Hemorrhage; AMTSL; Active Management of the Third Stage of Labour

Outcome Measures

Primary Outcomes (4)

• Maternal outcome: Postpartum blood loss

  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)

  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

  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

  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)

Secondary Outcomes (5)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: All individuals identifying as female with the potential for vaginal delivery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda ULSS 8 Berica: lead

Study Sites (1)

Ospedale San Bortolo

Vicenza, Vicenza, 36100, Italy

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesca carolo

  Aulss 8 Berica

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: July 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

IT (1)