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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

Jan 20, 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

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


Primary outcome(s)

1.

Neonatal Haemoglobin Concentration

[

24 to 48 hours after delivery

]

Secondary outcome(s)

1.
  1. To compare the difference between preoperative and postoperative haemoglobin values in mothers of two groups

  2. To compare Mean Birth weight [At the time of delivery] between the two groups.

  3. To compare Duration of surgery [From the start of surgery (skin incision) till the end of surgery (skin suturing)] between the two groups.

  4. To compare Blood loss (estimated blood loss using visual assessment) during the surgery between the two groups.

  5. To compare primary and secondary postpartum hemorrhage rates and rates of additional uterotonics use between the two groups

  6. To compare postpartum endometritis and postpartum sepsis rates between the two groups

  7. To compare Apgar score at 5 minutes after delivery between the two groups

  8. To compare direct serum bilirubin values of newborns 24 hours after delivery between the two groups

  9. To compare serum ferritin values of newborns at 6 weeks postpartum between two groups

  10. To compare rates of transient tachypnoea of newborn between the two groups

  11. To compare rates of infantile respiratory distress syndrome of newborn between the two groups

  12. To compare rates of neonatal jaundice between the two groups

  13. To compare NICU and PBU Admission rate between the two groups.

  14. To compare requirement of phototherapy and exchange transfusion between the two groups.

  15. To compare rates of respiratory, diarrheal and febrile illness which need inward treatment between infants belonging to the two groups

  16. To compare ages and stages development scores (ASQ-3) at 9 months of age between the two groups.

  17. 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)?

No


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

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results