Preterm Birth
Conditions
Keywords
Preterm birth, Early preterm birth, Very low birth weight, Low birth weight, Pregnancy outcome, Docosahexaenoic acid (DHA), Randomized cliinical trial, Superiority trial, Adaptive design
Brief summary
The purpose of this study is to determine if giving a larger amount of DHA than currently included in some prenatal supplements can reduce early preterm birth (birth before 34 weeks of pregnancy).
Detailed description
Docosahexaenoic acid (DHA) is a nutrient found in some fish and eggs and its intake in US diets is typically low. Because DHA is important for early brain development, it has recently been added to many prenatal supplements. The usual amount is around 200 mg/day. Participants in this study are guaranteed to receive at least 200 mg/day of DHA. Almost 5 in 100 births in the US occur before 34 weeks of pregnancy. There is no way to predict which births will occur before 34 weeks. In an earlier study conducted at the University of Kansas Medical Center, women who received 600 mg DHA/day compared to no DHA had fewer births before 34 weeks of pregnancy with fewer complications of preterm birth. This study is designed to compare standard care (200 mg/day of DHA) to a higher amount of DHA (1000 mg/day) to determine if the higher amount will reduce early preterm birth (birth before 34 weeks of pregnancy). Individual participation in this study is expected last about 5 months.
Interventions
DRUGDocosahexaenoic acid - 800mg/day
All participants will take 1000 mg/DHA per day (1 capsule will be labeled with 200 mg; 2 capsules will be masked with 400 mg each)
DRUGDocosahexaenoic acid - 200mg/day
The control group will receive 1-capsule containing 200 mg DHA/d.
OTHERPlacebo
Participants will receive 2 capsules (masked) containing half soybean oil and half corn oil equaling 800 mg.The soybean and corn oil combination does not contain DHA.
Sponsors
University of Cincinnati
Ohio State University
Nationwide Children's Hospital
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant females 18 years and older 12 to 20 weeks gestation at study entry * Agree to consume study capsules and a typical prenatal supplement of 200 mg DHA * Available by telephone * Able to speak and read in either English or Spanish language
Exclusion criteria
* Expecting multiple infants * Gestational age at baseline \<12 weeks or \>20 weeks * Unable or unwilling to agree to consume capsules until delivery * Unwilling to discontinue use of another prenatal supplement that contains greater than or equal to 200 mg DHA per day * Women with allergy to any component of DHA product (including algae), soybean oil or corn oil
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Early Preterm Birth (<34 weeks gestation) | Baseline to 34 Weeks | Bayesian posterior mean and 95% credible interval of pregnancies which result in an early preterm birth (birth before 34 weeks of pregnancy) by DHA dose |
| Maternal and infant adverse and serious adverse events | Enrollment to 30 days past last birth | Bayesian posterior mean and 95% credible interval by dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal and infant DHA status | birth | Bayesian posterior mean and 95% credible interval red blood cell phospholipid DHA (weight percent of total fatty acids) at enrollment and birth by dose |
| Gestational age | birth | Bayesian posterior mean and 95% credible interval weeks gestation at birth by dose |
| Birth weight | birth | Bayesian posterior mean and 95% credible interval in grams by dose |
| Length and head circumference | birth | Bayesian posterior mean and 95% credible interval in centimeters by dose |
| Preterm birth (<37 weeks) | birth | Bayesian posterior mean and 95% credible interval in weeks by dose |
| Low birth weight | birth | Bayesian posterior mean and 95% credible interval \<2500 grams by dose |
| Gestational diabetes | 12-20 weeks gestation through birth at an average of 40 weeks | Bayesian posterior mean and 95% credible interval by dose |
| Cesarean section | birth | Bayesian posterior mean and 95% credible interval by dose |
| Spontaneous labor | birth | Bayesian posterior mean and 95% credible interval by dose |
| Admissiion of neonate to a neonatal intensive care unit | birth | Bayesian posterior mean and 95% credible interval by dose |
| Pre-eclampsia | 12-20 weeks gestation through birth at an average of 40 weeks | Bayesian posterior mean and 95% credible interval |
| Very low birth weight | At birth | Bayesian posterior mean and 95% credible interval \<1500 grams by dose |
Countries
United States
Outcome results
None listed