MedDataX Logo

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

NCT ID: NCT04351997

Last Updated: 2020-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Placental Transfusion in the 'Natural' Delivery: Effect of Early and Late Umbilical Cord Clamping

NCT04459442

Hematocrit Anemia Acidosis
UNKNOWN NA

Delayed Cord Clamping and Use of Oxytocin

NCT02618499

Placental Transfusion
TERMINATED PHASE3

Prevention of Post-partum Haemorrhage

NCT01044082

Postpartum Haemorrhage Immediate Postpartum Hemorrhage
COMPLETED NA

Cord Clamping Level Above or Below Mother's Perineum

NCT02659605

Pre-term Birth Delayed Cord Clamping
COMPLETED NA

Short-Delay Cord Clamping Compared to Extended- Delay Cord Clamping in Term Neonates That Require Resuscitation.

NCT02827409

Placental Transfusion
COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Placental Transfusion Hematocrit Anemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The investigators conducted a randomized controlled trial (RCT) ,(parallel group study wit(h 1:1 randomisation) comparing early cord clamping( ECC) (at 60 seconds) and delayed cord clamping DCC) (at 180 seconds) in 90 cases of normal birth by' two-step' delivery.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early cord clamping

Cord clamping at 60 seconds after birth.

Group Type EXPERIMENTAL

Cord clamping

Intervention Type PROCEDURE

Umbilical cord clamping after delivery.

Delayed cord clamping

Cord clamping at 180 seconds after birth,

Group Type EXPERIMENTAL

Cord clamping

Intervention Type PROCEDURE

Umbilical cord clamping after delivery.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cord clamping

Umbilical cord clamping after delivery.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Vaginal delivery Gestational age \>37 weeks Natural process of labor

Exclusion Criteria

Cesarean section Fetal distress Major isoimmunisation Ccongenital diseases Cord abnormalities.
Minimum Eligible Age

2 Days

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Policlinico Abano Terme

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vincenzo Zanardo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Policlinico Abano Terme

Abano Terme, Padua, Italy

Site Status

Policlinico Abano Terme

Abano Terme, , Italy

Site Status

Padua University Hospital

Padua, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3158/AT/14

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Intraumbilical Oxytocin Versus Placental Cord Drainage in the Management of 3rd Stage of Labor
NCT03395730 UNKNOWN PHASE2
Efficacy of Direct CAtheterisation of the OMbilical Vein in Emergency Through Wharton's Jelly
NCT06915467 NOT_YET_RECRUITING PHASE2
Relationship Between Delivery Route and Fetal Complications With Doppler Indices and CPR Parameters
NCT04158609 COMPLETED
Postpartum Oxytocin Administration in the Era of Delayed Cord Clamping
NCT04632264 COMPLETED NA
Physiological Effects of Deferred Cord Clamping
NCT01864421 TERMINATED
In Vitro Evaluation of Spontaneous and Oxytocin-induced Contractility of Pregnant Human Myometrium During Exposure to Dexmedetomidine
NCT05511415 COMPLETED NA
Intravenous Versus Intramuscular Administration of Methylergonovine for Uterine Contraction in Cesarean Sections
NCT03303235 WITHDRAWN EARLY_PHASE1
Lactate Values During Labour and Their Correlation With Maternal and Foetal Outcome
NCT06807255 COMPLETED
The Role of ARTificial Uterine CONtractions in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section
NCT03899597 NOT_YET_RECRUITING NA
Cervical Traction vs. Active Management of 3rd Stage of Labor
NCT04747015 UNKNOWN NA
Controlled Cord Traction During Third Stage of Labor
NCT00781066 COMPLETED PHASE3
Maternal Oral Hydration and External Cephalic Version
NCT01911481 COMPLETED NA
Active Versus Expectant Management of the Third Stage of Labor
NCT00473707 COMPLETED NA
Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial
NCT04277962 TERMINATED NA
Foley Bulb Traction for Cervical Ripening
NCT00976703 COMPLETED NA
Study to Evaluate is ECV Success is Improved and the Side Effects Reduced With the Use of IV NTGL Versus Terbutaline
NCT02115256 TERMINATED PHASE2/PHASE3
Maternal Oxygen Use During Delivery and Cord Blood Superoxide Dismutase
NCT01042262 COMPLETED NA
Oxytocin Administration in the Third Stage of Labour - A Study of Appropriate Route and Dose
NCT00200252 COMPLETED PHASE4
Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension
NCT02265965 COMPLETED PHASE4
Acute Tocolysis With Terbutaline for Suspected Fetal Distress
NCT05326269 COMPLETED NA
Intravenous Nitroglycerin for Retained Placenta Extraction: a Multicenter Study
NCT00707928 COMPLETED PHASE4
Twin Vaginal Breech Deliveries Before and After Starting Training Skills and Clinical Approach in Labor Ward
NCT06628843 ACTIVE_NOT_RECRUITING
The Effects of Increased IV Hydration on Nulliparous Women Undergoing an Induction of Labor
NCT02989571 COMPLETED EARLY_PHASE1
Balanced Crystalloids in Postpartum Hemorrhage
NCT03824743 UNKNOWN
Placental Cord Drainage Versus no Placental Drainage in the Management of Third Stage of Labour
NCT03137810 UNKNOWN NA