Comparison of resuscitation given to newborn at the time of birth with cut versus uncut umbilical cord

Phase 3

Completed

• Conditions: Health Condition 1: P00-P04- Newborn affected by maternal factors and by complications of pregnancy, labor, and delivery

• Registration Number: CTRI/2020/02/023379
• Lead Sponsor: Government Medical College and Hospital Chandigarh

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-01-15
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 162

Inclusion Criteria

Study subjects: Neonates born at >34 weeks of gestation and requiring resuscitation at birth will be eligible for enrolment in the study. Two-step screening will be done to identify the eligible subjects.

Step 1: Screening to detect fetuses at increased risk of resuscitation at birth

Inclusion criteria for screening potentially eligible deliveries:

Parturient women admitted in labor/delivery area of the hospital will be approached for consent if they meet following criteria:

1.Gestation at birth more than 34 weeks

AND

2.Any of the following risk factors increasing the probability of need of resuscitation at birth:

1. Preeclampsia or eclampsia

2. Maternal hypertension

3. Twin pregnancy (diamniotic diachronic twins)

4. Polyhydramnios/oligohydramnios

5. Fetal macrosomia

6. Intrauterine growth restriction

7. No prenatal care

8. Emergency cesarean delivery

9. Forceps or vacuum-assisted delivery

10. Breech or other abnormal presentation

11. Category II or III fetal heart rate pattern

12. Intrapartum bleeding

13. Chorioamnionitis

14. Shoulder dystocia

15. Meconium-stained amniotic fluid

Woman or her husband whose fetus is deemed to be at-risk of resuscitation at birth would be approached for consent to enroll in the study. After obtaining written informed consent, the yet to be born neonate would be randomized to one of the following study groups:

1.Intact cord resuscitation (ICR) group

2.Early cord clamping resuscitation (ECR) group

Randomization will be done using a random number sequence generated using a stratified blocked randomization schedule with 1:1 allocation. Stratification will be done for mode of delivery (cesarean and vaginal). Randomization code will be enclosed in serially numbered sealed opaque envelopes which will be opened after obtaining written informed consent.

Step 2: Assessing need of resuscitation and study intervention

Delivery of enrolled neonates will be attended a team trained in neonatal resuscitation and led by a senior resident. Among enrolled mothers, neonates requiring resuscitation at birth will be identified as per standard resuscitation algorithm by International Liaison Committee on Resuscitation (ILCOR).8 These neonates will receive the assigned intervention as per their randomization (ICR or ECR). In both the groups resuscitation will be carried out as per standard guidelines. Neonates who do not require resuscitation will not be given study intervention (excluded) and will be managed with routine care as prescribed in ILCOR. Any additional reasons precluding application of study intervention in otherwise eligible neonates will be noted

Exclusion Criteria

Exclusion criteria for screening potentially eligible deliveries:

Parturient women with any of the following criteria will not be considered for enrolment:

1. Congenital malformation or chromosomal abnormalities in fetus diagnosed in antenatal period

2. Monochorionic or Monoamniotic placentation

3. Triplets and higher order pregnancy

4. Abruption placenta or cord abnormalities

5. Invasive placentation like accrete and percreta

6. Anterior placenta previa (in case of cesarean section)

7. Fetal hydrops

8. Ruptured uterus

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expanded Apgar scoreTimepoint: At 5 minutes after birth