- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07666945
The Effects Of Prenatal Health Education On Birth Preparedness And Complication Readiness Among Pregnant Women
The Effects Of Prenatal Health Education On Birthpreparedness And Complication Readiness Among Pregnant Women In Districts Of West Shewa Zone: A Step-Wedged Randomized Controlled Trial
Study setting: The study will be conducted from May 1 to November 2026 in the West Shewa Zone.
Objectives: To measure the effect of health education on birth preparedness and complication readiness practice among pregnant women in the districts of the West Shewa Zone in 2026 (Stepped Wedge Randomized Controlled Trial) Null hypothesis (H₀): There will be no difference in the proportion of birth preparedness and complication readiness among pregnant women between intervention and control periods.
Alternative Hypothesis (Ha): Health education intervention on BPCR will result in a significant increase in the proportion of well-prepared pregnant women in the intervention periods across all study sites.
The study population will consist of randomly selected pregnant women in selected public health centers in Districts of west shewa zone.
The west shewa zone districts were selected by simple random sampling methods .Ejere, Ejersa Lefo and Holota districts were selected using simple random sampling .Then Five health centers namely Yaya , Olankomi, Gorba ,Ejere and Gilgel kuyu health centers from three districts of west shewa zone were selected.
Will be then randomized to time of crossover (step) using computer-generated sequences. Because of this, the study design involves a sequential rollout where all groups eventually receive the health education intervention aimed at evaluating birth preparedness and complication readiness changes. At the beginning, the five clusters were identified by simple random sampling. Sequential allocation or randomly assigning each cluster to a specific wedge or starting point will be conducted. At the baseline all clusters begin in the control phase. During the steps (every month to six months) one or more clusters cross over to the intervention phase (implementing BPCR education). During the end phases, all clusters are in the intervention group. The study involves cohort sampling; the same pregnant women are followed through the entire study for six months. All eligible pregnant women attending antenatal care during defined periods in each cluster will eventually receive health education.
Přehled studie
Postavení
Detailní popis
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Belete Feyera Olkaba, MPH
- Telefonní číslo: +251913694024
- E-mail: beletefeyera@yahoo.com
Studijní místa
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Oromiya
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Hāgere Hiywet, Oromiya, Etiopie, 119
- Nábor
- Selected Public Health Centers in the West Shewa Zone
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Pregnant women who are in the first trimester of their pregnancy (up to 16 weeks' gestation) and
- Pregnant women who have lived in the study area for more than six months will be included.
Exclusion criteria
- Pregnant women with serious illnesses or those who intend to move during the intervention's execution
- Severe conditions requiring intensive hospital follow-up.
- Pregnant women who have previously taken part in a similar study elsewhere will not be allowed to join.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: pregnant women who will take educational intervention
An intervention is rolled out sequentially to the trial participants' clusters of individuals over a number of time periods.
The order in which the different clusters of pregnant women receive the intervention is determined at random, and, by the end of the random allocation, all clusters of pregnant women will have received the intervention.
Stepped wedge designs incorporate data collection at each point where a new cluster of pregnant women receives the intervention.
Each participant will be assigned an identity number throughout the recruitment process.
To remind each participant of the date of the intervention and/or follow-up interview, their phone numbers will be recorded.
Leaflets will be distributed at each of the contact points as teaching aids.
The health education content or the module will be adopted from JHPIEGO and the Ethio Ministry of Health ANC education guidelines.
The adopted module will be evaluated by experts in the area of reproductive health
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both arms eventually will take educational interventions
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Žádný zásah: pregnant women who will receive routine health care
continue routine health care
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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birth preparedness and complication readiness
Časové okno: 6months
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If a woman reported that she willprearranges at least two of the five components of birth preparedness and complicationreadiness (willl be assessed by standard pretestedquestionnaires), she will be considered "well prepared forbirth."; But if a pregnant woman reports that she prearranges fewer than two components of birth preparedness and complication readiness, she will be considered "poorly prepared." These five components of birth preparedness and complication readiness are:
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6months
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Belete Feyera Teso, MPH, Bule Hora University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BHU/IOH-ERC/04/001/01
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
Časový rámec sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
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