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Randomised controlled trial to study early preterm delivery in pregnant women supplemented with DHA from second trimester

A randomised controlled trial to study the early preterm delivery in pregnant women between supplemented with 200 mg/day and 1000 mg/day of DHA from second trimester. - DHA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027146
Enrollment
1072
Registered
2020-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: DHA supplementation from 2nd trimester: Once daily supplementation of 1000mg DHA/day or 200mg/day DHA Control Intervention1: DHA supplementation from second trimester: Daily dose of DHA

Sponsors

Cloudnine Hospital
Lead Sponsor
Reckitt Benckiser
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant females of 18- 40 years of age Gestational age 12-20 weeks - Singleton pregnancy, irrespective of co morbidities - Dietary intake of DHA is - Available by telephone, to verify dietary compliance - South Asian population

Exclusion criteria

Exclusion criteria: - Women with allergy to any component of DHA product (including algae), soybean oil or corn oil - Uterine anomalies - Women with fetal anomalies at 20 weeks or early, which may require termination of pregnancy

Design outcomes

Primary

MeasureTime frame
To Compare the proportion of early preterm labour between high dose DHA (1000mg/day) and low dose DHA 200mg/dayTimepoint: At delivery—

Secondary

MeasureTime frame
To compare the following between high dose DHA (1000mg/day) and low dose DHA 200mg/day 1.Women with utero-placental insufficiency (IUGR, Preeclampsia) 2.Gestational Age at deliver 3.Birth weight 4.Gestational diabetes mellitus (GDM) 5.Pregnancy outcome: Spontaneous, Induced labour and LSCS Timepoint: At delivery—

Countries

India

Contacts

Public ContactDr Kishore Kumar R

Cloudnine Hospital

drkishore@cloudninecare.com9900155001

Outcome results

None listed

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