Timing of Umbilical Cord Clamping: One to Three Minutes vs. After Cessation of Cord Pulsation

NCT03844490 | Completed

• 1 other identifier: CORD
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

Brief Summary

The timing of umbilical cord clamping has been widely discussed in the scientific community. As part of the worldwide strategies to reduce childhood iron deficiency anemia, the incorporation of late clamping (at least one minute after delivery), has been adopted as an effective and low-cost measure for health services. The optimal timing for clamping, ( if until 3 minutes of delivery, or later, when the cord stops spontaneous pulse), still remains controversial. Also, doubts remain about the effect of late clamping of the umbilical cord on maternal outcomes. This study has the hypothesis that waiting for the cessation of the cord pulsation will not bring harm to the newborn or the mother.

Conditions

Umbilical Cord

Keywords

Postpartum Hemorrhage; Neonatal jaundice; Umbilical cord

Outcome Measures

Primary Outcomes (2)

• Neonatal Hyperbilirubinemia requiring phototherapy

  clinical situation where hyperbilirubinemia indicates phototherapy. The need for phototherapy will be identified from the analysis of the laboratory results of total bilirubin, applying the values established by the American Academy of Pediatrics (AAP).

  24 to 7 days after birth

• Neonatal hemoglobin concentration 24-48 h postpartum

  expressed the concentration of neonatal hemoglobin, collected between 24 and 48 hours postpartum

  24 to 48 hours after birth

Secondary Outcomes (21)

• Weight of the newborn

  1 hour postpartum

• Apgar Score in the first and fifth minutes

  5 minutes

• Skin-to-skin contact

  5 hours

• Duration of skin-to-skin contact

  5 hours

• Breastfeeding in the first hour after birth

  1 hour

Study Arms (2)

CONTROL

OTHER

In this group management will be carried out as usual routine (cord clamping from one to three minutes after delivery)

Other: CONTROL

CESSATION OF CORD PULSE

EXPERIMENTAL

In this group the umbilical cord will remain unclamped until the spontaneous pulsation stops. At this time, cord clamping will be made.

Other: CESSATION OF CORD PULSE

Interventions

CESSATION OF CORD PULSE OTHER

In this group the umbilical cord will remain unclamped until the spontanous pulsation stops. At this time, cord clamping will be made.

CESSATION OF CORD PULSE

CONTROL OTHER

In this group management will be carried out as usual routine (cord clamping from one to three minutes after delivey)

CONTROL

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (pregnant women)
• Low risk pregnancy;
• Full-term pregnancy (37 to 42 weeks);
• Single fetus;
• Cephalic presentation;
• Normal birth;
• Euthocic delivery. (newborns)
• Live birth;
• Apgar\> 7 in the first minute and fifth minutes.

You may not qualify if:

• Early clamping for any reason (indicated by assistant);
• Instrumental delivery (forceps);
• Chorioamnionitis;
• Placental abruption;
• Prolapse of umbilical cord;
• Congenital anomaly;
• Labor analgesia.

Sponsors & Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira: lead
• Hospital Da Mulher do Recife: collaborator

Study Sites (1)

Instituto Materno Infantil Prof. Fernando Figueira

Recife, Pernambuco, 50.070-550, Brazil

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Jaundice, Neonatal

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; Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia

Study Officials

• LEILA KATZ, MD, PhD

  IMIP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the Obstetrical Intensive Care Unit

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: April 1, 2019
• Primary Completion: December 2, 2019
• Study Completion: January 23, 2020
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)