Smartphone Message to Improve the Drug Compliance in Pregnant Women.

Not Applicable

• Conditions: Pregnancy Related
• Interventions: Device: smartphone message

• Registration Number: NCT04295265
• Lead Sponsor: The University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-23
• Status Verified: 2020-03
• Study Start: 2020-03-01
• Study First Submitted QC: 2020-03-02
• Last Update Submitted: 2020-03-02
• Study First Posted: 2020-03-04
• Last Update Posted: 2020-03-04
• Primary Completion: 2023-02-28
• Study Completion: 2024-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 228

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone	smartphone message	Receive daily whatsapp/ SMS message remind the drug intake.

Primary Outcome Measures

Name	Time	Method
Compliance	through study completion, an average of 9months	number of tablet taken/ total number of tablets expected to take