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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 5 June 2017
Main ID:  ISRCTN14478662
Date of registration: 11/05/2017
Prospective Registration: No
Primary sponsor: Georgia State University
Public title: An affordable solution for strengthening the backbone of maternal care during childbirth
Scientific title: Priming rural facilities for optimal service delivery
Date of first enrolment: 01/03/2014
Target sample size: 26280
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN14478662
Study type:  Interventional
Study design:  Randomised cross over trial (Treatment)  
Phase: 
Countries of recruitment
Pakistan
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Musharraf    Cyan
Address:  Georgia State University 14 Marietta St. NW, 551 30300 Atlanta United States of America
Telephone: +1 404 413 0244
Email: cyan@gsu.edu
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: 1. All maternal care health workers in the 72 health facilities
2. All pregnant women who applied to the 72 health facilities

Exclusion criteria: 1. No pregnant women attending rural health facilities
2. Women attending health facilities for ANC visits
3. Health workers at the health facilities not tasked with maternal care and/or EmOC services


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Maternal health
Pregnancy and Childbirth
Maternal health
Intervention(s)
Participants are randomized to receive the two study conditions in a random order using a randomization command in Stata. All the participating facilities are randomly assigned to eight groups and two time periods. All participants in a facility receive the treatment exposure or control treatment assigned to the facility. Groups are balanced with 9 facilities in each group. During time period 1, the first 6 months of the study, facilities in Groups 1, 2 and 3 receive 6 visits (1 monthly mentoring visit for 6 months) , 3 visits (1 mentoring visit once in 2 months), and 1 mentoring visit at the start of the time period, respectively. Facilities in Group 4, 5, 6, 7 and 8 do not receive any mentoring visit during the first 6 months. At 6 months, Groups 5, 6 and 7 are exposed to treatment while Groups 1, 2 and 3 move into control. Facilities in Group 5, 6 and 7 receive 6, 3 and 1 mentoring visit during time period 2. Facilities in Group 1, 2, 3, 4 and 8 are not exposed to mentoring visits in time period 2.

Control: Participants undergo basic training of health care workers. This involves a one-day refresher workshop on EmoC conducted by OBGYN specialists.

Intervention: Participants undergo the same basic training of health care workers as the control group, with the addition of mentoring visits through post graduate doctors. These visits involve onsite discussions and demonstration of EmOC methods.

Follow up takes place after 12 months and involves review of clinical management notes compiled from monthly facility records.
Primary Outcome(s)
Rate of application of emergency obstetric care management options is assessed by reviewing clinical management notes from baseline to 12 months.
Secondary Outcome(s)
1. Rate of application of appropriate diagnosis is assessed by reviewing clinical management notes from baseline to 12 months
2. Usage of parental antibiotics is assessed by reviewing clinical management notes from baseline to 12 months
3. Usage of uterotonic drugs is assessed by reviewing clinical management notes from baseline to 12 months
4. Knowledge, attitudes, and practices (KAP) scores are assessed by reviewing clinical management notes at 6 and 12 months
Secondary ID(s)
H14055
Source(s) of Monetary Support
International Food Policy Research Institute
Secondary Sponsor(s)
King Edward Medical University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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