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Smartphone Message to Improve the Drug Compliance in Pregnant Women.

A Randomized Controlled Trial on the Use of Smartphone Message to Improve the Drug Compliance in Pregnant Women.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04295265
Enrollment
228
Registered
2020-03-04
Start date
2020-03-01
Completion date
2024-02-28
Last updated
2020-03-04

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

Conditions

Pregnancy Related

Brief summary

As technology advances, smartphones are now widely available and can provide a convenient and effective means to improve drug compliance by sending an electronic reminder on a regular basis. In a meta-analysis of 16 RCTs in assessing of drug compliance in chronic diseases, text message significantly improves medication compliance (OR, 2.11; 95% CI, 1.52-2.93; P \< 0.001). The drug compliance improves from 50% to 67.8%, or an absolute increase of 17.8%. Further evaluation is required as most of these RCTs relies on self-reported compliance. This data may be not applicable to pregnant women and trial of using this approach to improve drug compliance during pregnancy is lacking. The investigators hypothesize that the use of smartphone message will improve the drug compliance in pregnant women requiring long term medications. The investigators propose a randomized controlled trial to evaluate the effect of smartphone message.

Interventions

DEVICEsmartphone message

Receive daily whatsapp/ SMS message to remind the drug intake

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All women age ≥ 18 years old * Able to receive electronic reminder through smartphohne * Gestational age less than 16 completed weeks as defined by pelvic ultrasound * Part 1: Need to take aspirin or progesterone for prevention of pre-eclampsia or preterm birth respectively * Part 2: Given multivitamin as health supplementation

Exclusion criteria

For Part 1: * History of adverse reaction to aspirin * History of adverse reaction to progesterone * History of breast or genital tract malignancy * History of suspected thromboembolic disease * Congenital uterine anomaly * Unwillingness or inability to comply with study procedures * Known paternal or maternal abnormal karyotype

Design outcomes

Primary

MeasureTime frameDescription
Compliancethrough study completion, an average of 9monthsnumber of tablet taken/ total number of tablets expected to take

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026