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A randomized, placebo-controlled clinical trial for Oral Pyridoxine for nausea and vomiting in early pregnancy

A randomized, placebo-controlled clinical trial for Oral Pyridoxine for nausea and vomiting in early pregnancy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022982
Enrollment
Unknown
Registered
2019-05-06
Start date
2019-05-15
Completion date
Unknown
Last updated
2019-05-13

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

Conditions

nausea and vomiting in early pregnancy

Interventions

Group A:Oral Pyridoxine 60mg/d
Group B:Oral placebo 6 pills/d

Sponsors

Guangzhou Women and Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 35 Years

Inclusion criteria

Inclusion criteria: 1. Maternal aged between 18 and 35 year old; 2. Primipara; 3. Gestational age before 13weeksaccording to a reliable ultrasound confirmation; 4. Living fetus; 5. Having mild to moderate NVP and PUQE score 3-12, without a need of hospitalization; 6. Being literate.

Exclusion criteria

Exclusion criteria: 1. Severe nausea and vomiting during pregnancy requiring fluid therapy and hospitalization; 2. abortion; 3. With any known gastrointestinal disorder.

Design outcomes

Primary

MeasureTime frame
Pregnancy-Unique Quantification of Emesis and Nausea, PUQE;—

Countries

China

Contacts

Public ContactThomas Qintian Zheng

Guangzhou Women and Children's Medical Center

zhengqintian@yahoo.com+86 18902268420

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026