Trial · NCT00711971
Does Fish Oil Prevent Depression in Pregnancy and Postpartum?
NCT00711971, Phase 2, Phase 3, Completed, University of Michigan; results first posted 2017-04-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Does Fish Oil Prevent Depression in Pregnancy and Postpartum? Trials, record NCT00711971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00711971
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Does Fish Oil Prevent Depression in Pregnancy and Postpartum?
- NCT number
- NCT00711971
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 126 participants, actual
- Lead sponsor
- University of Michigan
- Conditions
- Depression
- Interventions
- EPA-rich fish oil supplement, DHA-rich fish oil supplement, placebo
- First posted
- 2008-07-09
- Last updated
- 2017-04-28
- Results first posted
- 2017-04-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Beck Depression Inventory | 6 - 8 weeks postpartum | The Beck Depression inventory scores depression based on 21 items, with a score of 0 - 3 on each item where 0 is no depression and a score of 31 or more is clinically depressed. The 21 items were summed to obtain the total score (The maximum possible score is 63.) |
| Other | Maternal Outcomes | visits at 26 - 28 weeks gestational age, 34-36 weeks gestational age during pregnancy and at the post partum visit 6- 8 weeks after delivery | While the maternal outcomes assess criteria during pregnancy and relating to delivery they were assessed at visits 26 - 28 weeks gestational age, 34-36 weeks gestational age and at the post partum visit 6- 8 weeks after delivery. |
| Other | Gestational Age at Delivery (Weeks) | delivery date was assessed by medical record review between 1 day and 8 weeks after delivery | |
| Other | Estimated Blood Loss (ml) | Within 24 hours after delivery | |
| Other | Neonatal Birthweight | immediately after birth | Mean weight in grams: where \<2500 gm is considered small for gestational age and \>4500 gm is considered large for gestational age. |
| Other | NICU (Neonatal Intensive Care Unit) Admissions | 6 weeks post delivery | Admission to the NICU |
| Other | One Minute Apgar Score | 1 minute after birth | Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the one minute Apgar. |
| Other | Five Minute Apgar Score | 5 minutes after birth | Apgar scores are based on a scale of 0 - 10 where 0 is a dead baby and 10 is an optimally vigorous newborn. The Apgar score analyzed here is the five minute Apgar. |
| Other | Cord Arterial pH | Immediately after birth (collected within the first hour after delivery) | Arterial blood gas analysis of umbilical cord blood |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Beck Depression Inventory | 6 - 8 weeks postpartum | Per protocol analysis is reported here. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Maternal Outcomes | visits at 26 - 28 weeks gestational age, 34-36 weeks gestational age during pregnancy and at the post partum visit 6- 8 weeks after delivery | Gestational hypertension and diabetes were self-reported for all participants so her data is included for those two rows.~One woman in the soy placebo arm delivered out of the geographic area, so documentation of delivery outcome is unavailable for analysis. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Gestational Age at Delivery (Weeks) | delivery date was assessed by medical record review between 1 day and 8 weeks after delivery | Gestational age is measured based on the pregnancy not the neonates, therefore although there were 40 babies born to the 39 mothers randomized to the EPA-rich fish oil, it is proper to consider the participants analyzed to be the 39 participating mothers. This is clarified still further by identifying the units appropriately as pregnancies. | weeks | MEAN |
| OTHER_PRE_SPECIFIED | Estimated Blood Loss (ml) | Within 24 hours after delivery | mL | MEAN | |
| OTHER_PRE_SPECIFIED | Neonatal Birthweight | immediately after birth | Data is provided for all babies on whom delivery weights were available with a set of twins in EPA rich fish oil arm and a delivery elsewhere for whom no birth weight was available for one baby from a mother in the Soy oil placebo arm. Thus there is 1 more participant than mothers participating in the EPA-rich arm and one less in the soy oil arm. | grams | MEAN |
| OTHER_PRE_SPECIFIED | NICU (Neonatal Intensive Care Unit) Admissions | 6 weeks post delivery | One set of twins in group A | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | One Minute Apgar Score | 1 minute after birth | One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Five Minute Apgar Score | 5 minutes after birth | One set of twins from EPA group; Soy oil arm has data for only 40 as one baby was born elsewhere so Apgar data is not available. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Cord Arterial pH | Immediately after birth (collected within the first hour after delivery) | Umbilical cord gases (pH) were sent at the discretion of the delivering physician and so were not available for all participants. | pH | MEAN |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Beck Depression Inventory | EPA-rich Fish Oil Supplement | BDI at 24-28 weeks' gestation | 7.9 | Standard Deviation 3.7 | units on a scale |
| Beck Depression Inventory | DHA-rich Fish Oil Supplement | BDI at 24-28 weeks' gestation | 6.5 | Standard Deviation 4.7 | units on a scale |
| Beck Depression Inventory | Soy Oil Placebo | BDI at 24-28 weeks' gestation | 6.3 | Standard Deviation 4.1 | units on a scale |
| Beck Depression Inventory | EPA-rich Fish Oil Supplement | BDI at 34-36 weeks' gestation | 7.4 | Standard Deviation 5.0 | units on a scale |
| Beck Depression Inventory | DHA-rich Fish Oil Supplement | BDI at 34-36 weeks' gestation | 5.9 | Standard Deviation 4.9 | units on a scale |
| Beck Depression Inventory | Soy Oil Placebo | BDI at 34-36 weeks' gestation | 7.2 | Standard Deviation 5.2 | units on a scale |
| Beck Depression Inventory | EPA-rich Fish Oil Supplement | BDI at 6-8 weeks postpartum | 6.6 | Standard Deviation 5.2 | units on a scale |
| Beck Depression Inventory | DHA-rich Fish Oil Supplement | BDI at 6-8 weeks postpartum | 5.1 | Standard Deviation 4.4 | units on a scale |
| Beck Depression Inventory | Soy Oil Placebo | BDI at 6-8 weeks postpartum | 6.2 | Standard Deviation 6.5 | units on a scale |
| Maternal Outcomes | EPA-rich Fish Oil Supplement | Gestational Hypertension or Preeclampsia | 8 | participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EPA-rich Fish Oil Supplement | 42 | |
| Overall Study | STARTED | DHA-rich Fish Oil Supplement | 42 | |
| Overall Study | STARTED | Soy Oil Placebo | 42 | |
| Overall Study | COMPLETED | EPA-rich Fish Oil Supplement | 39 | |
| Overall Study | COMPLETED | DHA-rich Fish Oil Supplement | 38 | |
| Overall Study | COMPLETED | Soy Oil Placebo | 41 | |
| Overall Study | NOT COMPLETED | EPA-rich Fish Oil Supplement | 3 | |
| Overall Study | NOT COMPLETED | DHA-rich Fish Oil Supplement | 4 | |
| Overall Study | NOT COMPLETED | Soy Oil Placebo | 1 |
Source ClinicalTrials.gov
Adverse events45
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Aftertaste | Gastrointestinal disorders | EPA-rich Fish Oil Supplement | 7 | 42 | |
| other | Aftertaste | Gastrointestinal disorders | DHA-rich Fish Oil Supplement | 8 | 42 | |
| other | Aftertaste | Gastrointestinal disorders | Soy Oil Placebo | 7 | 42 | |
| other | Belching | Gastrointestinal disorders | EPA-rich Fish Oil Supplement | 11 | 42 | |
| other | Belching | Gastrointestinal disorders | DHA-rich Fish Oil Supplement | 14 | 42 | |
| other | Belching | Gastrointestinal disorders | Soy Oil Placebo | 12 | 42 | |
| other | Gestational Diabetes | Endocrine disorders | EPA-rich Fish Oil Supplement | 5 | 42 | |
| other | Gestational Diabetes | Endocrine disorders | DHA-rich Fish Oil Supplement | 0 | 42 | |
| other | Gestational Diabetes | Endocrine disorders | Soy Oil Placebo | 1 | 42 | |
| other | Infant Jaundice | Blood and lymphatic system disorders | EPA-rich Fish Oil Supplement | 9 | 40 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EPA-rich Fish Oil Supplement | ||
| Total, all-cause mortality | DHA-rich Fish Oil Supplement | ||
| Total, all-cause mortality | Soy Oil Placebo | ||
| Total, other adverse events | EPA-rich Fish Oil Supplement | 28 | 42 |
| Total, other adverse events | DHA-rich Fish Oil Supplement | 23 | 42 |
| Total, other adverse events | Soy Oil Placebo | 22 | 42 |
| Total, serious adverse events | EPA-rich Fish Oil Supplement | 8 | 42 |
| Total, serious adverse events | DHA-rich Fish Oil Supplement | 5 | 42 |
| Total, serious adverse events | Soy Oil Placebo | 5 | 42 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AT004166 | Does EPA or DHA prevent depressive symptoms in pregnancy and postpartum? | MOZURKEWICH, ELLEN | UNIVERSITY OF MICHIGAN AT ANN ARBOR | NATIONAL CENTER FOR COMPLEMENTARY & INTEGRATIVE HEALTH | 2008 to 2011 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00711971
GET https://conductscience.org/api/trials/v1/NCT00711971/results?page=2