Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Family Planning Intentions and Practices Among Women With Poor Obstetric Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02674542
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief 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.


Condition or disease Intervention/treatment
Stillbirth Other: In-depth interviews Other: Focus Group

Detailed 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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Family Planning Intentions and Practices Among Women Who Have Experienced a Poor Obstetric Outcome: a Qualitative Study
Study Start Date : February 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: In-depth interviews
    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
  • Other: Focus Group
    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


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674542


Locations
Layout table for location information
Malawi
UNC Project
Lilongwe, Malawi
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Layout table for investigator information
Principal Investigator: Dawn Kopp, MD, MPH UNC-CH

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02674542     History of Changes
Other Study ID Numbers: UNCPM 21416
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of North Carolina, Chapel Hill:
Family planning
Birth spacing

Additional relevant MeSH terms:
Layout table for MeSH terms
Stillbirth
Fetal Death
Pregnancy Complications
Death
Pathologic Processes