NCT02674542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 4, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

January 22, 2016

Last Update Submit

February 1, 2019

Conditions

Keywords

Family planningBirth spacing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    1 year

Interventions

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

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Project

Lilongwe, Malawi

Location

Related Publications (2)

  • Bula A, Kopp DM, Maman S, Chinula L, Tsidya M, Tang JH. Family planning knowledge, experiences and reproductive desires among women who had experienced a poor obstetric outcome in Lilongwe Malawi: a qualitative study. Contracept Reprod Med. 2018 Oct 17;3:22. doi: 10.1186/s40834-018-0075-8. eCollection 2018.

  • Kopp DM, Bula A, Maman S, Chinula L, Tsidya M, Mwale M, Tang JH. Influences on birth spacing intentions and desired interventions among women who have experienced a poor obstetric outcome in Lilongwe Malawi: a qualitative study. BMC Pregnancy Childbirth. 2018 May 31;18(1):197. doi: 10.1186/s12884-018-1835-9.

MeSH Terms

Conditions

Stillbirth

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Fetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Dawn Kopp, MD, MPH

    UNC-CH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

February 4, 2016

Study Start

February 1, 2015

Primary Completion

October 1, 2015

Study Completion

June 1, 2016

Last Updated

February 4, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations