Effect of Delayed Cord Clamping on Haematological Status... | NCT01487980

Studies
Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants

NCT01487980

Sponsor

Stanger Hospital

Status

Completed

Last Update Posted

Dec 18, 2012Estimated

Enrollment

102Estimated

Phase

Not Applicable

Conditions

Low Birth Weight
Perinatology
Iron Status
Cord Clamping

Interventions

Cord clamping

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Dec 5, 2011

First Submission Date that Met QC Criteria

Dec 6, 2011

First Posted Date

Dec 8, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2012

Last Update Posted Date

Dec 18, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

S. Tiemersma, Medical Officer, Stanger HospitalPrincipal Investigator

Lead Sponsor

Stanger HospitalOTHER

Collaborators

Name	Class
Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron status until six months after birth, without increasing the risk of polycythaemia or other adverse events. We hypothesize that this intervention will also benefit low birth weight infants in South Africa.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early cord clamping	Active Comparator	Within 30 seconds after birth.	Procedure: Cord clamping
Delayed cord clamping	Experimental	Between 2 and 3 minutes after birth	Procedure: Cord clamping

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cord clamping	Procedure	Early vs Delayed	Delayed cord clamping Early cord clamping

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Haemoglobin level		two months

Secondary Outcomes

Measure	Description	Time Frame
Hyperviscosity syndrome		1 day
Iron status		two months
hyperbilirubinaemia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant mothers with SFH measurements below the cutpoint are eligible for inclusion. We aim to include infants with a birth weight below 2500 grams, but the actual birthweight can only be assessed after birth. We therefore accept an error of 500 grams (20%) and will include newborns up to 3000 grams. Birthweight will be measured after randomisation and study treatment.

Exclusion Criteria:

twin pregnancy
history of postpartum haemorrhage (PPH)
(gestational) diabetes
pre-eclampsia
abruptio placentae
caesarian section
necessity of early clamping due to tight nuchal cord
need for resuscitation immediately after birth
major congenital abnormalities

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sybrich Tiemersma, MD	Stanger Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanger Hospital		KwaDukuza	KwaZulu-Natal	4450	South Africa

Intervention Browse Module

MeSH Terms

ID	Term
D000087526	Umbilical Cord Clamping

Ancestor Terms

ID	Term
D036861	Delivery, Obstetric
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

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