Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor
1 other identifier
interventional
60
1 country
1
Brief Summary
The goal of this clinical trial is to learn about the effects of Docosahexaenoic acid (DHA) in reducing the incidence of premature birth in threatened preterm labor The main questions it aims to answer are:
- Can DHA supplementation reduce the incidence of premature birth in threatened preterm labor?
- How does DHA supplementation affect pregnancy outcomes? Participants were organized into two groups
- Group 1 (Intervention) Participants will be asked to take a DHA 1000mg per day
- Group 2 (control) Participant will not need to take a DHA
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2024
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2024
CompletedDecember 12, 2024
December 1, 2024
6 months
March 1, 2024
December 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants with preterm birth
Delivery at less than 37 weeks of gestational age
at delivery time
Secondary Outcomes (2)
Rate of low birth weight neonate
at delivery time
Rate of Neonatal Intensive care unit admission
at delivery time
Study Arms (2)
DHA supplement
EXPERIMENTALDHA supplement 1000mg per day
no DHA supplement
NO INTERVENTIONno DHA supplement
Interventions
Pregnant women will be ask to take a DHA 1000 mg per days at bedtime until delivery or 37 week of gestational age
Eligibility Criteria
You may qualify if:
- Singleton pregnancy
- Between 24 wk to 34 wk of gestational age
- Pregnant women diagnosed threatened preterm labor (with no cervical change)
You may not qualify if:
- Fetal anomalies
- Multiple pregnancy
- Premature rupture of membrane
- Placental disorders: placenta previa, placental abruption
- Fetal growth restriction
- Pregnancy complication: gestational diabetes mellitus, Chronic hypertension
- Allergic reaction to DHA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KhonKaenU
Khon Kaen, KhonKaen, 40000, Thailand
Related Publications (1)
Phattharachindanuwong W, Chaiyarach S, Komwilaisak R, Saksiriwuttho P, Duangkum C, Kongwattanakul K, Kleebkaow P, Waidee T, Pongsamakthai M, Chantanavilai S, Srisataporn T. Docosahexaenoic acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor. The Multicenter Randomized Controlled Trial. Int J Womens Health. 2025 Mar 30;17:937-945. doi: 10.2147/IJWH.S518312. eCollection 2025.
PMID: 40183030DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Fellow, Maternal and Fetal medicine department, Obstetrics and gynecology department
Study Record Dates
First Submitted
March 1, 2024
First Posted
March 8, 2024
Study Start
April 1, 2024
Primary Completion
October 7, 2024
Study Completion
October 7, 2024
Last Updated
December 12, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 1 year 4 months