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Completed

NCT Number: NCT02674542

Family Planning Intentions and Practices Among Women With Poor Obstetric Outcome

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.

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Key information

Conditions

Stillbirth Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

UNC Project

Lilongwe, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Current admission to the postpartum ward at Bwaila Hospital,
  • 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,
  • Ability to speak Chichewa or English fluently, and
  • Age 18-45 years old.

Exclusion criteria

  • Not willing to be audio-recorded
  • Have not experienced stillbirth or early neonatal death

Treatment and study plan

In-depth interviews

Other
  • 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

Other
  • 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

Primary outcomes

  1. Attitudes surrounding future fertility, birth spacing, family size, and contraception

    Time frame: 1 year

    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.

Secondary outcomes

  1. Discovering feasible and acceptable interventions to promote birth spacing and family planning among women who have experienced a poor obstetric outcome

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Feb 4, 2016
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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