Slctr

A Comparison of Effects of Umbilical Cord Non Severance at Birth and Delayed Cord Clamping on Iron Stores of the newborns Who Delivered By Elective Lower Segment Caesarean Sections: Double Blinded Randomized Control Trial

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SLCTR Registration Number

SLCTR/2020/001

Date of Registration

16 Jan 2020

The date of last modification

Sep 09, 2020

Application Summary

Scientific Title of Trial

A Comparison of Effects of Umbilical Cord Non Severance at Birth and Delayed Cord Clamping on Iron Stores of the newborns Who Delivered By Elective Lower Segment Caesarean Sections: Double Blinded Randomized Control Trial

Public Title of Trial

Effects of Umbilical Cord Non Severance at Birth and Delayed Cord Clamping on Iron Stores of the newborns Who Delivered By Elective Lower Segment Caesarean Sections: Double Blinded Randomized Control Trial

Disease or Health Condition(s) Studied

Iron deficiency anaemia in newborns

Scientific Acronym

None

Public Acronym

Modified Lotus Birth

Brief title

Modified Lotus Birth Study

Universal Trial Number

U1111-1234-8747

Any other number(s) assigned to the trial and issuing authority

No. 47/19

Trial Details

What is the research question being addressed?

Is umbilical cord non-severance better than delayed cord clamping with regard to haemoglobin concentration of neonates delivered by elective lower segment caesarean section?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Double blinded : Participants, Outcome assessors

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Other

Study Phase

Phase 2

Intervention(s) planned

In both groups, after the delivery of the baby, the placenta will be delivered manually by traction after delivering the baby. Cord clamping and cutting will be different in the two groups after this point. In the intervention group the placenta will be put into a sterile polythene bag and will be handed over to the midwife with the baby. It will remain with the baby for 15 minutes (in such manner that placenta remains a higher level than the baby) and then will be separated by cutting the cord using a sterile scissors after clamping cord at two points. The control group will have cord clamping after 2 minutes or once the cord pulsations have ceased, whichever comes earlier. In both the groups the placenta will be kept above the baby’s chest level before the clamping is done.

Inclusion criteria

All mothers undergoing elective caesarian section at 37 – 42 weeks of gestation. (Category 4 caesarean sections) and their newborn babies

Exclusion criteria

Babies that require positive pressure ventilation or any other advanced resuscitation soon after the birth
Meconium stained liquor
Babies with abnormal cardiotocographic changes/ abnormal Doppler flows
Major Congenital anomalies of the fetus
Multiple pregnancies
Rhesus negative mothers
Maternal Anaemia (iron deficiency and non-iron deficiency )
Mothers with haemoglobinopathies
Mothers with BMI < 18
Mothers who are strict vegetarians or who can’t tolerate oral iron supplements
Maternal diabetes (Gestational/ Pre-gestational)
Oligohydramnios (amniotic fluid index <6 )
Estimated fetal weight less than 2.5kg or more than 3.5kg
Maternal smoking (active or passive) or consume alcohol
Antepartum haemorrhage, diagnosed placenta previa or placental abruption
Patients with pre-eclampsia or any other obstetric or medical complications
Non cephalic presentations
Mothers with age less than 18
Mothers with psychiatric disorders that make them unable to give a valid consent
Mothers who are living in prisons, orphanages
Mothers who are positive for HIV or with unknown HIV status.
Mothers with previous babies who have had neonatal jaundice.
Mothers who are undergoing emergency caesarean section
Fetal hydrops which may be detected at antenatal ultrasound scan patients will be removed.

Primary outcome(s)

Neonatal Haemoglobin Concentration

[
24 to 48 hours after delivery
]

Secondary outcome(s)

To compare the difference between preoperative and postoperative haemoglobin values in mothers of two groups
To compare Mean Birth weight [At the time of delivery] between the two groups.
To compare Duration of surgery [From the start of surgery (skin incision) till the end of surgery (skin suturing)] between the two groups.
To compare Blood loss (estimated blood loss using visual assessment) during the surgery between the two groups.
To compare primary and secondary postpartum hemorrhage rates and rates of additional uterotonics use between the two groups
To compare postpartum endometritis and postpartum sepsis rates between the two groups
To compare Apgar score at 5 minutes after delivery between the two groups
To compare direct serum bilirubin values of newborns 24 hours after delivery between the two groups
To compare serum ferritin values of newborns at 6 weeks postpartum between two groups
To compare rates of transient tachypnoea of newborn between the two groups
To compare rates of infantile respiratory distress syndrome of newborn between the two groups
To compare rates of neonatal jaundice between the two groups
To compare NICU and PBU Admission rate between the two groups.
To compare requirement of phototherapy and exchange transfusion between the two groups.
To compare rates of respiratory, diarrheal and febrile illness which need inward treatment between infants belonging to the two groups
To compare ages and stages development scores (ASQ-3) at 9 months of age between the two groups.
To compare infant weight at 9 months of age between the two groups

[
1.between 24 hours before surgery and 24 hours after surgery 2. At the time of delivery 5. From time of delivery till 10 days after delivery 6. From time of delivery till 6 weeks after delivery 10.From time of delivery till 24 hours after delivery 11. From time of delivery till 24 hours after delivery 12.From time of delivery till 4 weeks after delivery 13.From time of delivery till 6 weeks after delivery 14.From time of delivery till 4 weeks after delivery 15.From time of delivery till 1 year after delivery]
]

Target number/sample size

158

Countries of recruitment

Sri Lanka

Anticipated start date

2020-01-20

Anticipated end date

2021-11-01

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

Self funded

Regulatory approvals

Not Applicable

State of Ethics Review Approval

Status

Approved

Date of Approval

2019-11-21

Approval number

47/19

Details of Ethics Review Committee

Name:	University of Sri Jayewardenepura
Institutional Address:	Faculty of Medical Sciences, University of Sri Jayewardenepura, Gangodawila, Nugegoda, Sri Lanka
Telephone:	0112758588
Email:	erc.fms.usjp@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Amila Janalal Rubasinghe
Registrar
General Hospital, Matara
+94 11 2758000 Ext: 4376
0763288214

amilajr1@gmail.com

Contact Person for Public Queries

Dr. M.A.M.M Jayawardane
Senior lecturer
Department of Obstetrics & Gynaecology, Faculty of Medical Sciences, University of Sri Jayewardenepura

0773140500

madurammj@yahoo.com/

Primary study sponsor/organization

General Hospital, Matara
0763288214

amilajr@gmail.com

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

IPD sharing plan description

There will be no individual participant level data shared. Any data in particular will not be accessible to three parties and individual participant data that underlie the results reported in the article after de-indetification will only be available for the investigator and will not be accessible to any one else. Other documents such as the study protocol would only be accessible by the investigator and his research team.

Study protocol available

Yes

Protocol version and date

2, 11 September 2019

Protocol URL

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results