Planned early delivery versus expectant management in pregnat women having high blood pressure

CRADLE 4 Trial: Planned early delivery versus expectant management to reduce adverse pregnancy outcomes in pre-eclampsia in a low and middle-income setting. - CRADLE4 Phase 2

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/022771

Enrollment

872

Registered

2020-01-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: O140- Mild to moderate pre-eclampsia

Interventions

Intervention1: Planned early delivery versus expectant management to reduce adverse pregnancy outcomes in pre-eclampsia in a low and middle-income setting.: Pregnant women who are diagnosed as having

Eligibility

Inclusion criteria

Inclusion criteria: 1. Viable ongoing pregnancy at time of recruitment 2. Clinical diagnosis of pre-eclampsia confirmed by a doctor 3. Gestational age between 34+0 and 36+6 confirmed by a doctor

Exclusion criteria

Exclusion criteria: A decision to deliver within 48hrs has already been made by a senior clinician

Design outcomes

Primary

Measure	Time frame
Maternal mortality and morbidity based on the miniPIERS composite of adverse maternal outcomes, during pregnancy and delivery until primary hospital discharge with the addition of severe hypertensionTimepoint: Maternal mortality and morbidity during pregnancy and delivery until primary hospital discharge	—

Secondary

Measure	Time frame
1. Maternal:Time and mode of delivery. ICU admission, Use of Magnesium Sulphate, Use of Antenatal Corticosteroids, use of Anti-hypertensives 2. GA at delivery, Birthweight, Admissions to NNU, Sepsis, APGAR score at 5 and 10 minutes post birth, Need for neonatal resuscitation, HIE and Grade, Neonatal seizures, RDS, CPAP required, Invasive ventilation support, Administration of surfactant, Hypo-glycaemia, NEC, NG feeding.Timepoint: From the time of Randomization till discharge of mother and baby	—

Measure

Time frame

1. Maternal:Time and mode of delivery. ICU admission, Use of Magnesium Sulphate, Use of Antenatal Corticosteroids, use of Anti-hypertensives 2. GA at delivery, Birthweight, Admissions to NNU, Sepsis, APGAR score at 5 and 10 minutes post birth, Need for neonatal resuscitation, HIE and Grade, Neonatal seizures, RDS, CPAP required, Invasive ventilation support, Administration of surfactant, Hypo-glycaemia, NEC, NG feeding.Timepoint: From the time of Randomization till discharge of mother and baby

—

Countries

India, Zambia

Contacts

Public ContactDr Umesh S Charantimath

Jawaharlal Nehru Medical College, KAHER

drumesh.charantimath@gmail.com9663712777

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026