MAKER FOR MNCH

CLINICAL PROTOCOL FOR ASSESSING THE SAFETY AND EFFECTIVENESS OF LOCALLY MANUFACTURED LOW COST MEDICAL EQUIPMENT FOR MATERNAL, NEWBORN, AND CHILD HEALTH: A PROSPECTIVE, NON-RANDOMIZED, QUASI- EXPERIMENTAL, CONTROLLED TRIAL FOR THE IMPROVEMENT OF MATERNAL, NEWBORN, AND CHILD HEALTHCARE IN NAIROBI, KENYA

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

PACTR

Registry ID

PACTR201902736872339

Enrollment

100

Registered

2019-02-11

Start date

2018-12-03

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Neonatal Diseases Pregnancy and Childbirth

Interventions

Suction Aspirator

Standard of Care

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Women undergoing cesarean section 2. Neonates requiring suction during delivery 3. Informed consent from women undergoing cesarean section

Exclusion criteria

Exclusion criteria: 1. Women with other co-morbidities 2. Neonates with comorbidities including a diagnosis of non-reassuring fetal state.

Design outcomes

Primary

Measure	Time frame
1. Functionality 2. Ease Of Use 3. Frequency Of Break Down 4. Number of break downs 5. Total Break Down Time 6. Access Of Spare Parts	—

Secondary

Measure	Time frame
Number Of Adverse Events	—

Countries

Kenya

Contacts

Public ContactJohn Ongech

Deputy Director Surgical Services Kenyatta National Hospital

jongech@yahoo.com254722282449

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026