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

December 7, 2024 updated by: Wiphawi Phattharachindanuwong, Khon Kaen University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • KhonKaen
      • Khon Kaen, KhonKaen, Thailand, 40000
        • KhonKaenU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DHA supplement
DHA supplement 1000mg per day
Dietary supplement: Docosahexaenoic acid (DHA) 1000 mg
Pregnant women will be ask to take a DHA 1000 mg per days at bedtime until delivery or 37 week of gestational age
Other Names:
  • NOW
No Intervention: no DHA supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with preterm birth
Time Frame: at delivery time
Delivery at less than 37 weeks of gestational age
at delivery time

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of low birth weight neonate
Time Frame: at delivery time
Newborn's weight at birth is less than 2500g
at delivery time
Rate of Neonatal Intensive care unit admission
Time Frame: at delivery time
newborn need neonatal intensive care
at delivery time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

October 7, 2024

Study Completion (Actual)

October 7, 2024

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 6, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Estimated)

December 12, 2024

Last Update Submitted That Met QC Criteria

December 7, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE661462

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

1 year 4 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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