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Completed

NCT Number: NCT02770456

Fish Oil Supplementation to Pregnant Women in China

This randomized controlled trial with fish oil supplementation to pregnant women conducted in areas of China, which are generally low in fish intake and low income, aims at answering the following primary questions:

* Is a dose of 2.0 g/d long chain n-3 fatty acids efficient in preventing preterm birth * Is a dose of 0.5 g/d long chain n-3 fatty acids efficient in preventing preterm birth * Is a dose of 0.5 g/d as efficient as a dose of 2.0 g/d in affecting timing of spontaneous delivery in the preterm period

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

20 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The basic design is that of a randomized controlled trial with three groups randomized in ratios of 1:1:1. Two different doses of long chain n-3 fatty acids are tested against zero grams long chain n-3 fatty acids (lc-n3FA). These are provided in similarly looking gelatine capsules with either fish oil, a mixture (1:3) of fish oil and olive oil, or olive oil. Eligible women are randomized at around gestation weeks 16-24 and are asked to take the capsules until they have completed the preterm period (i.e. at 37 full gestation weeks) or until they deliver. Women are asked to complete questionnaires at randomization about diet and other baseline information, and again in gestation week 30 and after delivery. The trial is undertaken at hospitals in the two provinces of Gan-Su and Shaanxi. The three randomization groups will be compared with respect to proportions of preterm delivery. Cox regression will be used to compare the groups with respect to rates of spontaneous deliveries while accounting for elective delivery by regarding these as censoring events.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnancy without known complications

Exclusion criteria

  • Regular user of fish oil
  • Regular user of NSAIDs
  • Known twin pregnancy

Treatment and study plan

High dose fish oil

Dietary Supplement

Four 0.72-gram gelatine capsules per day with fish oil providing 2.0 g/d lc-n3FA

Low dose fish oil

Dietary Supplement

Four 0.72-gram gelatine capsules per day with a mixture of fish oil and olive oil providing 0.5 g/d lc-n3FA

Olive Oil

Dietary Supplement

Four 0.72-gram gelatine capsules per day with olive oil providing 0 g/d lc-n3FA

Primary outcomes

  1. Premature birth

    Time frame: 20 weeks on average, from randomization at gestation weeks 16-24 until on average gestation week 40

    Delivery occurring earlier than 259 gestation days

Sponsors and collaborators

Lead sponsor

Centre for Fetal Programming, Denmark

Other

Collaborators

  • Shanghai Institute of Planned Parenthood Research

Registry information

Official study title

Fish Oil Supplementation to Prevent Preterm Delivery in China: A Randomized Controlled Trial

Acronym: FOPCHIN

Important dates

Study start
2008
Primary completion
2015
Study completion
2016
First posted
May 12, 2016
Registry last updated
May 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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