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A cluster randomised effectiveness trial of a standardised childbirth preparation education programme for primigravid women to alleviate postnatal depression

A cluster randomised effectiveness trial of a standardised childbirth preparation education programme for primigravid women to alleviate postnatal depression

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202603665018582
Enrollment
274
Registered
2026-03-11
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental and Behavioural Disorders

Interventions

Routine care
Childbirth preparation education programme

Sponsors

North West University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Primigravid women Aged 18 to 35 years A singleton pregnancy Gestational age determined to between 28 and 34 weeks at randomisation Scheduled to receive antenatal care and birth at the selected recruitment and birthing sites Proficient in English or isiXhosa since these are the common languages in these facilities. Must have a contactable phone number and contactable physical address

Exclusion criteria

Exclusion criteria: HIV positive and on ARV treatment, with CD4 count of less < 350 cells/?L Participant on any other chronic medications other than routine antenatal medicines and antiretroviral medication. Participants who were previously diagnosed with any mental illness. Participants taking nonprescriptive addictive drugs.

Design outcomes

Primary

MeasureTime frame
The prevalence of PND (score> 10) using Edinburgh Postnatal Depression Scale (EPDS), developed by Cox et al. (1987).

Secondary

MeasureTime frame
Measure fear of childbirth using the revised Wijma Delivery Expectancy/Experience Questionnaire (Wijma, 2005; Massae et al., 2022).;Measure childbirth satisfaction using the Birth Satisfaction Scale-Revised Indicator (BSS-RI) developed by Martin et al. (2017) and childbirth experience using Childbirth Experience Questionnaire (CEQ), developed by Dencker et al. (2010).;Measure self-esteem using the Rosenberg Self-Esteem Scale (Rosenberg, 1965).;Measure birth outcomes i.e induction of labour, augmentation of labour, the use of analgesia, number of assisted birth, number of caesarean sections, prevalence of premature labour and number of neonatal admissions to the neonatal intensive care unit

Countries

South Africa

Contacts

Public ContactPatience G. Kovane

Promoter

patience.kovane@nwu.ac.za0182892537

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026