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Intact Cord Placental Delivery vs Delayed Cord Clamping (TTC)

2026년 7월 14일 업데이트: 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.

연구 개요

상태

모집하지 않고 적극적으로

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

1979

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

이탈리아
- Vicenza
  - Vicenza, Vicenza, 이탈리아, 36100
    - Ospedale San Bortolo

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Maternal outcome: Postpartum blood loss 기간: 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) 기간: 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 기간: 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 기간: 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)

2차 결과 측정

결과 측정	측정값 설명	기간
Maternal outcome: duration of the third stage of labour 기간: 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 기간: 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 기간: 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 기간: 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 기간: within 24 hours of birth		within 24 hours of birth

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Azienda ULSS 8 Berica

수사관

연구 의자: Francesca carolo, Aulss 8 Berica

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 15일

기본 완료 (추정된)

2027년 7월 31일

연구 완료 (추정된)

2027년 7월 31일

연구 등록 날짜

최초 제출

2026년 3월 20일

QC 기준을 충족하는 최초 제출

2026년 7월 14일

처음 게시됨 (실제)

2026년 7월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)