Family Planning Intentions and Practices Among Women With Poor Obstetric Outcome

Stillbirth Clinical Trial

Official title:

Family Planning Intentions and Practices Among Women Who Have Experienced a Poor Obstetric Outcome: a Qualitative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674542
• Other study ID #: UNCPM 21416
• Status: Completed
• Start date: February 2015
• Est. completion date: June 2016

Study information

• Verified date: February 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

1. Current admission to the postpartum ward at Bwaila Hospital,

2. Women who have delivered a stillborn fetus over 28 weeks gestation or with a birthweight >1000 g or experienced a neonatal demise of a liveborn infant, weighing >1000 g in the first 7 days of life,

3. Ability to speak Chichewa or English fluently, and

4. Age 18-45 years old.

Exclusion criteria:

• Not willing to be audio-recorded

• Have not experienced stillbirth or early neonatal death

Related Conditions & MeSH terms

• Stillbirth

Intervention

Other:
• In-depth interviews
Future family planning intentions and beliefs Family planning experiences and beliefs: Feasibility and acceptability of birth spacing promotion for women who experienced a still birth or early neonatal demise
• Focus Group
Future family planning intentions and beliefs Family planning experiences and beliefs: Feasibility and acceptability of birth spacing promotion for women who have experienced a stillbirth or early neonatal demise

Locations

Country	Name	City	State
Malawi	UNC Project	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year