Evaluation of the iron status and cardiopulmonary stabilisation for the first 10 minutes after birth with two different techniques of DCC i.e. cord clamping at 1 minute and after placental delivery among late preterm infants not requiring resuscitation

Physiological versus one minute based delayed cord clamping among late preterm infants not requiring resuscitation a randomised controlled trial - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067918

Enrollment

230

Registered

2024-05-27

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Physiological based cord clamping that is cord clamping after separation of placenta: This study is aimed at the evaluation of the iron status as a primary outcome and cardiopulmonary s

Eligibility

Inclusion criteria

Inclusion criteria: 1. Late preterm (34+0 - 36+6 weeks) singleton pregnancy with anticipated delivery (gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available) 2. Parents residing within 100 kilometers of Jodhpur & consenting to follow up till first 6-8 weeks of age

Exclusion criteria

Exclusion criteria: 1. Cesarean section under general anesthesia (GA) due to any reason (contra-indication or procedure failure or failure of effect of spinal anesthesia) 2. Multiple gestation 3. Psychiatric illness or maternal drugs which may interfere or prohibits breastfeeding 4. Mothers with HIV or AIDS 5. Rh iso-immunized pregnancy with evidence of hydrops fetalis 6. Non-immune hydrops fetalis 7. Any suspected or confirmed congenital anomaly or syndrome in the fetus 8. Chorioamnionitis or any systemic infection in last one week before delivery 9. Severe fetal growth restriction (fetal weight less than 3rd centile for that gestational age) or AEDF or REDF (absent end diastolic flow or reversed end diastolic flow

Design outcomes

Primary

Measure	Time frame
Primary outcome: 1. Serum ferritin levels at 6-8 weeks of ageTimepoint: six to eight weeks	—

Secondary

Measure	Time frame
Neonatal I. To compare birth weight II. To compare APGAR score at 1, 5 and 10 minutes of life III. To compare modified APGAR score at 5 and 10 minutes IV. To compare PCV at about 12 hours of age V. To compare the incidence of significant hyperbilirubinemia (jaundice requiring phototherapy and/or exchange transfusion as per American Academy of Pediatrics [AAP] charts) till dischargeTimepoint: six to eight weeks;VI. To compare incidence of respiratory support requirement due to any cause till discharge VII. To compare NICU admission till discharge VIII. To compare hemoglobin, incidence of iron deficiency and iron deficiency anemia at 14 (+4) weeks of age IX. To compare incidence of exclusive breastfeeding rate at 14 weeks of age X. To compare anthropometry (weight, length and head circumference) till 14 (+4) weeks of age XI. To compare incidence of hospitalization till 14 (+4) weeks of age XII. To compare morbidities (diarrhea, pneumonia, seizures) till 14 weeks of ageTimepoint: six to eight weeks;} Maternal I. To compare incidence of PPH II. To compare need for therapeutic uterotonics or surgical management or manual removal of placenta for PPH III. To compare need of blood transfusion IV. To compare ICU admission V. To compare all cause in-hospital maternal mortality till discharge VI. To compare fall in maternal haemoglobin 24 (?4) hours after deliveryTimepoint: six to eight weeks	—

Measure

Time frame

Neonatal I. To compare birth weight II. To compare APGAR score at 1, 5 and 10 minutes of life III. To compare modified APGAR score at 5 and 10 minutes IV. To compare PCV at about 12 hours of age V. To compare the incidence of significant hyperbilirubinemia (jaundice requiring phototherapy and/or exchange transfusion as per American Academy of Pediatrics [AAP] charts) till dischargeTimepoint: six to eight weeks;VI. To compare incidence of respiratory support requirement due to any cause till discharge VII. To compare NICU admission till discharge VIII. To compare hemoglobin, incidence of iron deficiency and iron deficiency anemia at 14 (+4) weeks of age IX. To compare incidence of exclusive breastfeeding rate at 14 weeks of age X. To compare anthropometry (weight, length and head circumference) till 14 (+4) weeks of age XI. To compare incidence of hospitalization till 14 (+4) weeks of age XII. To compare morbidities (diarrhea, pneumonia, seizures) till 14 weeks of ageTimepoint: six to eight weeks;} Maternal I. To compare incidence of PPH II. To compare need for therapeutic uterotonics or surgical management or manual removal of placenta for PPH III. To compare need of blood transfusion IV. To compare ICU admission V. To compare all cause in-hospital maternal mortality till discharge VI. To compare fall in maternal haemoglobin 24 (?4) hours after deliveryTimepoint: six to eight weeks

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Countries

India

Contacts

Public ContactDr K Krishna Kumar

AIIMS Jodhpur

neerajpgi@yahoo.co.in80039996908

Outcome results