Pregnant Women Diagnosed With Threatened Preterm LaborPhase 2NCT06302023
Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor
A Phase 2 study testing Docosahexaenoic acid (DHA) 1000 mg in people with Pregnant Women Diagnosed With Threatened Preterm Labor, run by Khon Kaen University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women Diagnosed With Threatened Preterm Labor
- What is being tested?
- Docosahexaenoic acid (DHA) 1000 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2024to 7 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton pregnancy
- Between 24 wk to 34 wk of gestational age
- Pregnant women diagnosed threatened preterm labor (with no cervical change)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Threatened preterm labor is defined as regular uterine contractions occurring before 37 completed weeks of gestation, without any cervical dilation.
- Being tested
- Docosahexaenoic acid (DHA) 1000 mg
- Keywords
- DHA, threatened preterm labor, Docosahexaenoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docosahexaenoic acid (DHA) 1000 mgDietary supplement
Also called NOW
Pregnant women will be ask to take a DHA 1000 mg per days at bedtime until delivery or 37 week of gestational age
| Study group | Role | What they receive |
|---|---|---|
| DHA supplement | Experimental | DHA supplement 1000mg per day Receives: Dietary Supplement: Docosahexaenoic acid (DHA) 1000 mg |
| no DHA supplement | No intervention | no DHA supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with preterm birth
Delivery at less than 37 weeks of gestational age
Measured: at delivery time
Secondary outcomes (2)
Rate of low birth weight neonate
Newborn's weight at birth is less than 2500g
Measured: at delivery time
Rate of Neonatal Intensive care unit admission
newborn need neonatal intensive care
Measured: at delivery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Apr 2024
- Primary completion7 Oct 2024
- Study completion7 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant Women Diagnosed With Threatened Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wiphawi Phattharachindanuwong, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302023
- Sponsor's protocol ID
- HE661462
- Status last verified
- Dec 2024
- First submitted
- 1 Mar 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40183030
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Docosahexaenoic Acid (DHA) Supplementation During Pregnancy Reduces the Risk of Preterm Birth in Threatened Preterm Labor
- ClinicalTrials.gov ID
- NCT06302023
- Acronym / sponsor ID
- HE661462
- Keywords
- DHA, threatened preterm labor, Docosahexaenoic acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 7 Oct 2024 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DHA supplement | Experimental | Dietary Supplement: Docosahexaenoic acid (DHA) 1000 mgDHA supplement 1000mg per day |
| no DHA supplement | No intervention | –no DHA supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Between 24 wk to 34 wk of gestational age
- Pregnant women diagnosed threatened preterm labor (with no cervical change)
Key exclusion criteria (7 listed)
- Fetal anomalies
- Multiple pregnancy
- Premature rupture of membrane
- Placental disorders: placenta previa, placental abruption
- Fetal growth restriction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docosahexaenoic acid (DHA) 1000 mgAlso: NOWPregnant women will be ask to take a DHA 1000 mg per days at bedtime until delivery or 37 week of gestational age | Dietary supplement | DHA supplement |
Primary outcome
Number of Participants with preterm birth
Time frame: at delivery time
Delivery at less than 37 weeks of gestational age
2 secondary outcomes
Rate of low birth weight neonate
Time frame: at delivery time
Rate of Neonatal Intensive care unit admission
Time frame: at delivery time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Derived from this study: PubMed 40183030Phattharachindanuwong 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.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docosahexaenoic acid (DHA) 1000 mg in people with Pregnant Women Diagnosed With Threatened Preterm Labor, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with preterm birth (time frame: at delivery time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06302023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.