A Cluster Randomized Controlled Intervention to Improve Institutional Birth Rate in a Rural District of Ethiopia

Maternal Health Services Clinical Trial

Official title:

Promoting Safe Motherhood in Ethiopia: A Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05385380
• Other study ID #: AMU-IUC-PHD3
• Status: Completed
• Phase: N/A
• Start date: September 14, 2019
• Est. completion date: November 20, 2020

Study information

• Verified date: May 2022
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite the efforts from the government, maternal healthcare services utilization is far below the recommended level in Ethiopia with a high urban-rural disparity. Currently, two-thirds of pregnant women do not receive the recommended number of antenatal care, more than 50% of births are not attended by skilled birth attendants, and two-thirds of postpartum women do not receive postnatal checks, according to the 2019 EDHS report. There is also evidence that the rate of continuity of maternity care completion is low, implying that pregnant women are not getting the most out of the existing healthcare services. In Ethiopia, the rural communities are scattered over a wide geographic area some with difficult mountains and valleys. Hence, geographic barriers and limited information sources are likely to influence women's access to skilled birth attendance. As part of improving access and overcoming physical or geographical inaccessibility in rural areas, maternity waiting homes; residential lodgings built near healthcare facilities where expectant women near or at term would stay till the onset of labor is one of the measures taken by the Ethiopian government. The majority of the rural populations commonly have a lower perception of health services in general, and many traditional practices support behaviors that are inconsistent with effective health interventions. Thus, there is a challenge concerning behavior (social norms, beliefs, and culture) from the demand side related to utilizing maternity services on top of non/partial functionality of existing waiting homes. Therefore, this research project aimed at promoting access to and utilization of maternal healthcare services utilization in southern Ethiopia.

Description:

Health centers and kebeles (villages) in the study setting were randomly assigned to intervention or comparison. We recruited all eligible pregnant women who reside in the respective selected health centres' catchment areas. In the intervention areas, community health workers (unpaid and volunteer women) were identified in consultation with the head of the villages/local leaders/. They received training on safe motherhood, the benefit and importance of maternity homes, identification of local beliefs, traditions and taboos that are barriers to birth preparation, stay in maternity homes and the use of maternal health services. The main functions of these trained community health worker in the intervention clusters include facilitating training sessions for pregnant women, assisting pregnant women in the preparation of birth preparedness plan, supporting pregnant women in starting and sustaining maternity care (prenatal care, skilled delivery and postnatal care). Pregnant women were also trained in the intervention clusters (12 sessions/4 sessions per cluster).

The training of both community health workers and pregnant women was based on a video story titled "Why Did Mr. X Die, Retold?" and a manual on working with individuals, families and communities to improve maternal and neonatal health from the World Health Organization.

After getting permission from the World Health Organization to use the video, we translated it into the local language and used it as an introduction during training. The training was designed based on the findings of preliminary studies and was intended to educate pregnant women about danger signs during pregnancy, labour and the postpartum period, about the birth preparation plan, the benefits and importance of waiting homes. In addition, it also covered how to develop a birth plan that included waiting home with the help of community health workers, as well as correcting misconceptions (belief-related barriers). The intervention was based on principles from the theory of planned behavior and the health belief model. These models were considered to offer direction for what types of variables and processes may be important in shaping maternal health behaviors and thus needed to be addressed in the intervention. The theory of planned behavior is used to explain and predict behavior based on attitudes, norms, and intentions and stipulates that an individual intention to act (behavior) is essentially a function of that individual's attitude toward that behavior and perceptions of social subjective norms. The health belief model which describes how health beliefs interact with modifying factors (e.g., perceived seriousness of problem) to determine health behaviors was also considered in developing the intervention.

The comparison group continued to receive maternal health information and services that are provided as part of the routine healthcare system. Both the baseline and end-line data were managed by trained interviewers using a mobile application supporting Open Data Kit. Data were analyzed through descriptive and inferential statistics (Chi-square test, McNemar tests and multi-level mixed-effects logistic regression analysis). For all analyses, a p-value of <0.05 was considered the level of significance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 727
• Est. completion date: November 20, 2020
• Est. primary completion date: October 17, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

Inclusion Criteria:

• Those who had resided for at least six months in the selected kebele clusters and had given birth in the five years preceding the survey were included to maintain homogeneity of information exposure. Another criterion for inclusion was a maximum gestational age of 27 weeks (end of second trimester) as participants were required to attend at least two sessions of the proposed promotional intervention before their due date.

Exclusion Criteria:

• Those who met the inclusion criteria but were critically ill at the time of enrolment and/or those who were reluctant to participate were excluded.

Related Conditions & MeSH terms

• Maternal Health Services

Intervention

Behavioral:
• Safe motherhood Promotion
Interventions included the training of community members, who subsequently led participatory educational sessions on safe motherhood topics with pregnant females. The project staff identified 2 community health workers and 15 female volunteers from each kebele cluster and trained them as research implementers. The implementers received 2 days of training led by the project team. The project staff and research implementers conducted safe-motherhood training comprising 2 h of information presentations and discussions with pregnant females in the intervention clusters. In addition to the pregnant-female intervention strategy, we also conducted a four-day training programme on clinical skills for local maternal and child healthcare providers in the study area. MWH intervention was also implemented in the intervention group, including upgrades to existing MWH services per national guidelines to standardize services and create a homelike environment for pregnant females.

Locations

Country	Name	City	State
Ethiopia	MEKDES KONDALE Gurara	Arba Minch	Southern Nations Nationalities Regional State

Sponsors (3)

Lead Sponsor	Collaborator
Prof Yves Jacquemyn	Arba Minch University, Ethiopia, Flemish Interuniversity Council (VLIR)

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the location of the delivery (home vs. health facility)	institutional birth was used to indicate skilled birth attendance as trained health workers do not conduct deliveries outside of health facilities in these areas.	through study completion, an average of 9 months
Primary	health facility visits after childbirth (postnatal care use)	Having visited postnatal clinic after delivery	through study completion, an average of 9 months
Secondary	knowledge of obstetric danger signs	Knowledge of birth danger signs was measured using the pregnant females' unprompted responses to the question related to the key danger signs during pregnancy, childbirth and postnatal period	through study completion, an average of 9 months
Secondary	birth preparedness practice	Proportion of pregnant women that made prior arrangements for birth and complications	through study completion, an average of 9 months