Overview

This trial has been completed.

Condition stillbirth
Treatments in-depth interviews, focus group
Sponsor Dawn Kopp, MD, MPH
Collaborator University of North Carolina, Chapel Hill
Start date February 2015
End date October 2015
Trial size 60 participants
Trial identifier NCT02674542, UNCPM 21416

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Attitudes surrounding future fertility, birth spacing, family size, and contraception
time frame: 1 year

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title Family Planning Intentions and Practices Among Women Who Have Experienced a Poor Obstetric Outcome: a Qualitative Study
Principal investigator Dawn Kopp, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.