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Active, Not Recruiting

NCT Number: NCT07713277

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Intact Cord Placental Delivery Delayed Cord Clamping Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Postpartum Hemorrhage (Primary) Pregnancy Complications Puerperal Disorders Standard Delayed Cord Clamping Timing of Cord Clamping Urogenital Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ospedale San Bortolo

Vicenza, 36100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Maternal outcome: Postpartum blood loss

    Time frame: during the immediate postpartum period (0-2 hours)

    2-hour postpartum blood loss

  2. Maternal outcome: Incidence of retained placenta requiring manual removal of the placenta (MROP)

    Time frame: 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

  3. Neonatal outcome: Requirement for phototherapy

    Time frame: During the hospital stay (up to 3 days)

    Incidence of neonates requiring phototherapy for hyperbilirubinemia

  4. Neonatal outcome: physiological weight loss during the early neonatal period

    Time frame: 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

Secondary outcomes

  1. Maternal outcome: duration of the third stage of labour

    Time frame: 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

  2. Neonatal outcome: apgar scores at 1, 5, and 10 minutes

    Time frame: 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.

  3. Neonatal outcome: umbilical artery pH at delivery

    Time frame: 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

  4. Neonatal outcome: neonatal resuscitation and NICU admission rates by placental delivery method

    Time frame: 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

  5. Neonatal outcome: haematocrit (Hct) levels at 24 hours of life

    Time frame: within 24 hours of birth

Sponsors and collaborators

Lead sponsor

Azienda ULSS 8 Berica

Other

Registry information

Official study title

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

Acronym: TTC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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