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Timing of delivery in women identified as having Hypertension in pregnancy

CRADLE-4 Phase 1: The feasibility and acceptability of planned early delivery in pre-eclampsia in a Low and Middle-Income Setting - CRADLE 4 Phase 1

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/01/017286
Enrollment
621
Registered
2019-01-28
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

None listed

Interventions

None listed

Sponsors

Department of Biotechnology Government of India
Lead Sponsor
Kings College London through Medical Research Centre London
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Women will be eligible for recruitment to a focus group if they are: 1. Over 18 years of age 2. Able to give valid consent 3. Currently pregnant with a viable, ongoing pregnancy Attending one of the designated trial sites for ante-natal care Partners will be eligible for recruitment to a focus group if they are: 1. Over 18 years of age 2. Able to give valid consent 3. The partner, or close family member, of a woman participating in a focus group who has given her permission for her partner/family member to be invited. Stakeholders will be eligible for recruitment to an interview if they are: 1. Over 18 years of age 2. Able to give valid consent 3. Identified as being a key stakeholder in the stakeholder analysis 4. Currently working as a member of staff at one of the designated trial sites

Exclusion criteria

Exclusion criteria: The one who is not able to consent, Less than 18 years of age

Design outcomes

Primary

MeasureTime frame
The results will be used to help design key aspects of the trial protocol for Phase 2 such as: â?¢Acceptable methods of gestational age determination â?¢Lower and upper limits of gestational age for the intervention (planned early delivery) â?¢Diagnostic criteria for pre-eclampsia â?¢Guidelines for planned delivery (i.e. local labour induction protocols) â?¢Guidelines for routine expectant management Timepoint: At 6 months the qualitative data will be analysed and decisions will be taken to make relevant changes for phase 2 trial.—

Secondary

MeasureTime frame
â?¢Components of maternal primary and secondary outcomes to be collected â?¢Components of neonatal primary and secondary outcomes to be collected Timepoint: 6 months—

Countries

India, Zambia

Contacts

Public ContactDr Umesh S Charantimath

Jawaharlal Nehru Medical College

drumesh.charantimath@gmail.com9663712777

Outcome results

None listed

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