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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: 14 January 2019
Main ID:  ISRCTN13529717
Date of registration: 27/07/2015
Prospective Registration: Yes
Primary sponsor: Institute of Research for Development, UMR 216
Public title: Impact of health professionals' training in primary health care facilities on maternal and neonatal health
Scientific title: Improving the quality of obstetric and neonatal care in primary health care facilities in rural Mali through health workers' training
Date of first enrolment: 01/09/2016
Target sample size: 1828
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN13529717
Study type:  Interventional
Study design:  Pragmatic two arms cluster randomized trial (Prevention)  
Phase: 
Countries of recruitment
Mali
Contacts
Name: Ines    Dossa
Address:  4, Avenue de l'Observatoire 75 006 Paris France
Telephone: +33 1 53 73 96 20
Email: ines.dossa@gmail.com
Affiliation: 
Name: Alexandre    Dumont
Address:  4 Avenue de l'Observatoire 75 006 Paris France
Telephone: +33 1 53 73 96 20
Email: alexandre.dumont@ird.fr
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
Patients:
1. Pregnant women presenting in one of the participating health facilities for antenatal care
2. Women who give birth in one of the participating health facilities or were referred to a higher-level facility during childbirth

Health professionals:
All the general practitioners, obstetric nurses, midwives, health technicians and midwives who provide care to pregnant women and newborns in the participating health centres of Diema will be included in the study.

Exclusion criteria: Women who have given birth at home and used postpartum healthcare services in one of the participating health centers

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Maternal and neonatal health
Pregnancy and Childbirth
Intervention(s)

Our Intervention consists in three complementary activities:
1. Training health workers to the use of the sandwich method
2. Training health workers in obstetric and neonatal optimal care
3. Supervision of obstetric teams for the implementation of best practices
Primary Outcome(s)

Current primary outcome measure as of 20/10/2015:
Proportion of health workers who use the sandwich method to estimate the date of last menstruation during first antenatal care visit.

Previous primary outcome measure:
Proportion of women who know the date of last menstruation.
Secondary Outcome(s)

Current secondary outcome measures as of 20/10/2015:
1. The proportion of women who know the date of last menstruation
2. The knowledge score of the health care professionals
3. The health workers' satisfaction score regarding their working conditions
4. The rate of transfer of pregnant women to a higher-level structure during pregnancy
5. The rate of transfer of women to a higher-level structure after delivery
6. The rate of transfer of newborn to a higher-level structure after delivery
7. The proportion of newborns diagnosed pre-term, small for gestational age or post-term
8. Perinatal mortality rate

All outcome measures will be measured one time before intervention and one time after intervention. Two rounds of supervision will be carried out.

Previous secondary outcome measures:
1. The proportion of health professionals that determine the date of last menstruation using the sandwich method
2. The knowledge score of the health care professionals
3. The health workers' satisfaction score regarding their working conditions
4. The rate of transfer of pregnant women to a higher-level structure during pregnancy
5. The rate of transfer of women to a higher-level structure after delivery
6. The rate of transfer of newborn to a higher-level structure after delivery
7. The proportion of newborns diagnosed pre-term, small for gestational age or post-term
8. Perinatal mortality rate

All outcome measures will be measured thus:
1. One year of pre-intervention data collection
2. One year of intervention implementation
3. One year of post-intervention data collection
Secondary ID(s)
N/A
Source(s) of Monetary Support
PEERS program (scientific and fund transfer collaboration agreement between IRD and URFOSAME), InfoDos program (Fonds Français Muskoka)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Not provided at time of registration
Results
Results available: Yes
Date Posted:
Date Completed: 31/08/2018
URL:
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