A study on the effect of demand and supply side interventions on maternal and neonatal mortality in three districts in Malawi

The effect of community mobilisation through women?s groups and health facility quality improvement on maternal and neonatal mortality in three districts of Malawi: a two-by-two factorial cluster randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18073903

Enrollment

45000

Registered

2011-04-20

Start date

2010-06-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Maternal and neonatal mortality Pregnancy and Childbirth Maternal and neonatal mortality

Interventions

1. Quality Improvement trial: Coaching of Health Facility staff in quality improvement methodology (including Plan-Do-Study-Act, Death Reviews, change ideas, bundles and packages) to improve obstetri

16 clusters with women's group (WG) intervention only, and 28 clusters with no interventions (control) 4. Note that the original design had 15 WG+QI, 17 QI only, 24 WG only, and 26 control clusters re

WG: 39, no WG 39 with 4 clusters only in the QI trial and 18 clusters only in the WG trial. This was not followed because some health centres (which the clusters were formed around) were not functioni

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: All pregnant women who agree to take part in the programme

Exclusion criteria

Exclusion criteria: Women who have no possibility of conceiving during the study period (women who have had hysterectomy or permanent sterilisation)

Design outcomes

Primary

Measure	Time frame
1. Maternal, neonatal and perinatal mortality, assessed by monthly community surveillance of all pregnant women and their infants until two months after delivery throughout the 27 month intervention period (01/10/08 to 31/12/2010). 2. Any mothers or infants who have died were followed up with a verbal autopsy interview to establish the cause of death	—

Secondary

Measure	Time frame
The following were determined through monthly community surveillance, monthly health facility surveillance and collection of process data on the interventions: 1. Percentage of deliveries at a health facility (for both interventions) 2. At facility level (for the quality improvement trial): 2.1. Percentage met need for emergency obstetric care 2.2. Number of deliveries at facility 3. Percentage of maternal deaths subjected to maternal death audit 4. Case fatality rate 5. Caesarean section rate 6. Practice of signal obstetric care functions 7. At the community level (for the women?s group trial): 7.1. No. of women?s groups mobilized annually 7.2. Percentage of women attending women?s groups	—

Measure

Time frame

The following were determined through monthly community surveillance, monthly health facility surveillance and collection of process data on the interventions: 1. Percentage of deliveries at a health facility (for both interventions) 2. At facility level (for the quality improvement trial): 2.1. Percentage met need for emergency obstetric care 2.2. Number of deliveries at facility 3. Percentage of maternal deaths subjected to maternal death audit 4. Case fatality rate 5. Caesarean section rate 6. Practice of signal obstetric care functions 7. At the community level (for the women?s group trial): 7.1. No. of women?s groups mobilized annually 7.2. Percentage of women attending women?s groups

—

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 23, 2026