Active — Not RecruitingNot Applicable

Intact Cord Placental Delivery vs Delayed Cord Clamping

Italy1,979 participantsStarted 2026-04-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maternal outcome: Postpartum blood loss

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

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

Timeframe: Within two hours of birth

Neonatal outcome: Requirement for phototherapy

Timeframe: During the hospital stay (up to 3 days)

Neonatal outcome: physiological weight loss during the early neonatal period

Timeframe: During the hospital stay (up to 3 days)

Trial details

NCT IDNCT07713277

SponsorAzienda ULSS 8 Berica

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07-31

View on ClinicalTrials.gov More Intact Cord Placental Delivery trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Maternal outcome: Postpartum blood loss

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

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

Timeframe: Within two hours of birth

Neonatal outcome: Requirement for phototherapy

Timeframe: During the hospital stay (up to 3 days)

Neonatal outcome: physiological weight loss during the early neonatal period

Timeframe: During the hospital stay (up to 3 days)