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Table 4 Inclusion and exclusion criteria for facilities and study participants

From: A clustered randomized control trial to assess feasibility, acceptability, and impact of implementing the birth companion intervention package in Ethiopia, Kenya, and Nigeria: study protocol

Participant

Inclusion

Exclusion

Health facilities

• Prior to randomization, head of facility grants permission for facility to participate in the study

• Be willing to develop, adopt, and implement the birth companion standard operating procedures and other components of the birth companion intervention package

• Have 16 to 30 births minimum per month during the past three months

• Be in the Addis Ababa and surrounding area of Ethiopia; Machakos or Murang’a County of Kenya; or Kano or Nasarawa States of Nigeria

• Facility staff strike or other disturbance to routine care noted prior to randomization that would pose significant challenge(s) to achieving the study objectives

Providers

• At the time of enrollment, work in antenatal care and/or labor and birth ward(s) of study facility

• Able and willing to provide informed consent to participate in the study

 

Mothers

• Per participant report, age 15 years or older

• Have a vaginal birth

• Able and willing to provide informed consent to participate in the study

• Unable to participate in an interview due to their physical or emotional condition (e.g., caused by an adverse birth outcome)

• Unable to provide valid information because of mental or other serious health condition

Birth companions

• For emancipated minors, age 15 years or older. If not an emancipated minor, 18 years or older. Age per participant report

• Person was present at labor and/or birth

• Identified as a birth companion by the birthing mother

• Willing and able to provide informed consent to participate in the study

• Unable to provide valid information because of mental or other serious health condition

Unit managers

• Involved in the implementation and management of the birth companion intervention

• Able and willing to provide informed consent to participate in the study

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