Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor

Phase 2

Completed

• Conditions: Pregnant Women Diagnosed With Threatened Preterm Labor
• Interventions: Dietary Supplement: Docosahexaenoic acid (DHA) 1000 mg

• Registration Number: NCT06302023
• Lead Sponsor: Khon Kaen University

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

Detailed Description

Threatened preterm labor is defined as regular uterine contractions occurring before 37 completed weeks of gestation, without any cervical dilation.

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-08
• Study Start: 2024-04-01
• Primary Completion: 2024-10-07
• Study Completion: 2024-10-07
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-07
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Singleton pregnancy
• Between 24 wk to 34 wk of gestational age
• Pregnant women diagnosed threatened preterm labor (with no cervical change)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DHA supplement	Docosahexaenoic acid (DHA) 1000 mg	DHA supplement 1000mg per day

Primary Outcome Measures

Name	Time	Method
Number of Participants with preterm birth	at delivery time	Delivery at less than 37 weeks of gestational age

Secondary Outcome Measures

Name	Time	Method
Rate of low birth weight neonate	at delivery time	Newborn's weight at birth is less than 2500g
Rate of Neonatal Intensive care unit admission	at delivery time	newborn need neonatal intensive care

Trial Locations

Locations (1)

KhonKaenU; 🇹🇭 Khon Kaen, KhonKaen, Thailand