Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery

Placental Transfusion Clinical Trial

Official title:

Early and Delayed Cord Clamping in Infants Born by 'Two-step' Vaginal Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04351997
• Other study ID #: 3158/AT/14
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: April 2020
• Source: Policlinico Abano Terme
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators conducted a RCT (parallel group study with 1:1 randomisation) comparing ECC (at 60 seconds) and DCC (at 180 seconds) in 90 cases of normal birth by' two-step' delivery. In term infants born by' two-step' delivery, DCC results is a higher blood volume in the newborn and facilitates the maternal-placental-fetal exchange of circulating compounds, without potentially detrimental neonatal outcomes.

Description:

Introduction: Placental transfusion supports an important blood transfer to the neonate, promoting a more stable and smooth transition from fetal to extra-uterine life with the potential to prevent iron deficiency in young children. Several studies have demonstrated that cord clamping timing is greatly relevant for facilitate placental transfusion, the transfer of extra blood from the placenta to the infant in the third stage of labor. Therefore, during natural 'two-step' delivery umbilical cord management may play a relevant role on blood passage to the neonate and it may affect neonatal hematological values and placental transfusion. The most effective way to manage umbilical cord in in 'two-step' delivery remains to be established.

Objective: The aim of the present study is to evaluate the effect of two different methods of umbilical cord management (Early Cord Clamping - ECC vs. Delayed Cord Clamping - DCC) on the placental transfusion, defined by in two-step delivery, by ∆ haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age. Accounting for physiological body weight decrease. Secondary outcomes included contemporary estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.

Material and methods: This is a randomized clinical trial on the effect of different cord management newborns born by 'two-step' delivery. After obtaining parental consent, all mothers > 38 weeks' gestation will be assigned to either ECC or DCC group in a 1:1 ratio according to a randomized sequence generated by an opened, sealed, numbered, opaque envelope containing the cord clamping interventions allocation, ECC (at 1 minute) or DCC (at 3 minutes after delivery).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 1, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Days

Eligibility

Inclusion Criteria:

Vaginal delivery Gestational age >37 weeks Natural process of labor

Exclusion Criteria:

Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.

Related Conditions & MeSH terms

• Hematocrit Anemia
• Placental Transfusion

Intervention

Procedure:
• Cord clamping
Umbilical cord clamping after delivery.

Locations

Country	Name	City	State
Italy	Policlinico Abano Terme	Abano Terme	Padua
Italy	Policlinico Abano Terme	Abano Terme
Italy	Padua University Hospital	Padua

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Abano Terme

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Placental transfusion	We compared the effects of ECC and DCC on placental transfusion in two-step delivery, by ? haematocrit (Hct) from arterial cord blood at birth and capillary blood at 48 h of age.	Second day of life
Secondary	Arterial cord blood gas analysis.	Estimate of blood gases, lactate, and glucose concentrations in arterial cord blood gas analysis.	Second day of life.
Secondary	Neonatal body weight decrease.	Neonatal body weight (Kg) and weight at discharge (Kg)	First and second day of life
Secondary	Blood gases	pH (units)	At birth
Secondary	Lactate	mmol/L	At birth
Secondary	Glucose	mg%	At birth