An observational study in Stillbirth, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in Malawi. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-04.
Sponsored by University of North Carolina, Chapel Hill · Observational
Women who have experienced a stillbirth or neonatal death are at higher risk of repeated poor neonatal outcomes if they have short interpregnancy intervals. Understanding the attitudes surrounding future fertility and contraception in this population is critical to propose socially and culturally acceptable interventions to address an unmet need for family planning.
Participants: Women who have experienced a stillbirth or early neonatal death will be recruited from the postnatal ward of Bwaila Maternity Hospital in Lilongwe, Malawi.
Procedures (methods): This will be a qualitative study using 20 in-depth interviews and four focus group discussions of up to 10 women each.
The investigators propose a qualitative study of up to 60 women who have experienced a stillbirth or early neonatal death. This will be a qualitative study using 20 in-depth interviews and four focus group discussions of up to 10 women each. In-depth interviews will be conducted in Chichewa in a private room either within the participants' homes or in another private location determined by the participant.
Each interview will take approximately 60-90 minutes to complete. The focus group discussions will be conducted in a private room in a health facility with 6-10 participants. These will take approximately 90-120 minutes to complete. Interviews and the focus group discussion will be audio-recorded, transcribed, and translated to English. If a participant is found to be eligible, she will be invited to participate in the study. After the investigators complete the in-depth interviews, the investigators will analyze the data and modify our focus group discussion guide as needed to integrate new themes that may have emerged during the individual interviews. The investigators will recruit 6-10 women per focus group (24 to 40 total) from the same hospital that were used to recruit for the individual interviews.
The investigators will search for recurrent patterns and themes in data and for ideas that help to explain the presence of these patterns. The data collection and analysis process is designed to be iterative, such that the investigators will be reviewing data as it is collected and adjusting the data collection instrument to reflect new themes that emerge during the data collection process. All interviews will be audio-recorded, transcribed, translated, coded and computerized for analysis.
117 studies on the registry are indexed under Stillbirth; 33 are open to participants now.
This study's enrollment of 60 is below the median of 794 across 50 observational studies indexed under Stillbirth.
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60 women who have experienced a stillbirth or early neonatal death. Study participants will be recruited from the postnatal wards at Bwaila Maternity Hospital in Lilongwe, Malawi.
Exclusion criteria:
1. Future family planning intentions and beliefs 2. Family planning experiences and beliefs: 3. Feasibility and acceptability of birth spacing promotion for women who experienced a still birth or early neonatal demise
1. Future family planning intentions and beliefs 2. Family planning experiences and beliefs: 3. Feasibility and acceptability of birth spacing promotion for women who have experienced a stillbirth or early neonatal demise
Attitudes surrounding future fertility, birth spacing, family size, and contraception
The investigators expect that the in-depth interviews and focus groups will allow them to better understand the family planning intentions and practices of women who have experienced a stillbirth or early neonatal demise.
Time frame: 1 year
Discovering feasible and acceptable interventions to promote birth spacing and family planning among women who have experienced a poor obstetric outcome
The investigators will ask women who have experienced a stillbirth or neonatal demise questions about a variety of potential interventions to assist women with birth spacing and elicit their ideas on acceptable interventions.
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill