- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02674542
Family Planning Intentions and Practices Among Women With Poor Obstetric Outcome
Family Planning Intentions and Practices Among Women Who Have Experienced a Poor Obstetric Outcome: a Qualitative Study
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
-
-
-
Lilongwe, Malawi
- UNC Project
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Attitudes surrounding future fertility, birth spacing, family size, and contraception
Lasso di tempo: 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.
|
1 year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Discovering feasible and acceptable interventions to promote birth spacing and family planning among women who have experienced a poor obstetric outcome
Lasso di tempo: 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.
|
1 year
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Dawn Kopp, MD, MPH, UNC-CH
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- UNCPM 21416
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .