A study to reduce pregnancy related complications, and all cause maternal and perinatal mortality and major morbidity in Karnataka State, India

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/01/004352
• Date of registration: 27-01-2014
• Prospective Registration: Yes
• Primary sponsor: The University of British Columbia
• Public title: A study to reduce pregnancy related complications, and all cause maternal and perinatal mortality and major morbidity in Karnataka State, India
• Scientific title: The CLIP (Community Level Interventions for Pre-Eclampsia)Cluster Randomized Controlled Trial - CLIP
• Date of first enrolment: 01-02-2014
• Target sample size: 81200
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8001
• Study type: Interventional
• Study design: Cluster Randomized Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India, Mozambique, Nigeria, Pakistan

Contacts

• Name: Dr M B Bellad
• Affiliation: J N Medical College

• Name: Dr M B Bellad
• Affiliation: J N Medical College

Key inclusion & exclusion criteria

Inclusion criteria: All pregnant women permanent residents in selected clusters of Belgaum and Bagalkot district of Karnataka
Exclusion criteria:

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Blood Pressure more than 160/90 mmhg or patient having high risk symptoms like blurring of vision, stroke, loss of consciousness, vaginal bleeding Health Condition 2: O141- Severe pre-eclampsia

Intervention(s)

Intervention1: Oral Methyldopa 750mg: Methyldopa administration in the community; relative maternal hypertension on arrival at facility (defined as sBP less than 110 mmHg)
Intervention2: Intramuscular MgSO4: 10g MgSO4 intramuscular loading dose (Single dose Only)
Control Intervention1: NIL: NIL

Primary Outcome(s)

The primary outcome will be combined maternal and or perinatal outcome (either maternal, fetal or neonatal death or severe morbidity for the mother or baby)Timepoint: During Antenatal, Delivery and Postnatal 42 day followup

Secondary Outcome(s)

Impact of the CLIP intervention on the delays around triage and transport.Timepoint: During Antenatal, Delivery and Postnatal 42 day followup

Secondary ID(s)

H12-00132

Source(s) of Monetary Support

The University of British Columbia, Vancouver, British Columbia, Canada V6T 1Z3

Ethics review

Status: Approved
Approval date: 10/04/2012
Contact:

JNMC Institutional Ethics Committee on Human Subjects Research

Status: Approved
Approval date: 07/09/2012
Contact:

Directorate of Health & Family Welfare Services, Government of Karnataka

Status: Approved
Approval date: 27/09/2012
Contact:

Indian Council of Medical Research New Delhi

Results

• Date Completed: 31/10/2016