Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21AT004166-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to test whether an alternative medicine treatment, fish oil, will prevent depressive symptoms in pregnant and postpartum women who have been found to be at risk for depression. Epidemiologists have observed that people who live in countries where people on average eat a diet high in fish have a lower risk of depression than people who live in populations that eat less fish. Postpartum depression is also less common in these countries. The omega-3 fatty acids found in fish oil are thought to be responsible for this beneficial effect of eating fish. The two major omega-3 fatty acids found in fish are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). DHA is an essential building block of the brain and nerve tissue. EPA may act to optimize the electrical signals between nerve cells and brain cells and may help the immune system to function well.
Some researchers have treated people who are already suffering from depression with fish oil. Some of these studies have shown a benefit for the fish oil treatment and others have not. These studies have tested EPA and DHA alone and in various combinations. Currently, it is not known whether EPA or DHA is more effective in preventing and treating depression. Some of the researchers involved in this study have learned how to identify mothers who are most at risk for developing depression during and after pregnancy. This study is designed to learn whether EPA-rich and DHA-rich fish oil supplements will prevent depressive symptoms in women who are at risk to develop depression.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPA-rich fish oil supplement | Active Comparator | EPA-rich fish oil supplement |
|
| DHA-rich fish oil supplement | Active Comparator | DHA-rich fish oil supplement |
|
| Soy Oil placebo | Placebo Comparator | Soy oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPA-rich fish oil supplement | Drug | 1060 mg EPA plus 274 mg DHA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory | 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.) | 6 - 8 weeks postpartum |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Outcomes | 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. | 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ellen Mozurkewich, MD, MS | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21696635 | Background | Mozurkewich E, Chilimigras J, Klemens C, Keeton K, Allbaugh L, Hamilton S, Berman D, Vazquez D, Marcus S, Djuric Z, Vahratian A. The mothers, Omega-3 and mental health study. BMC Pregnancy Childbirth. 2011 Jun 22;11:46. doi: 10.1186/1471-2393-11-46. | |
| 27656142 | Result | Mozurkewich EL, Greenwood M, Clinton C, Berman D, Romero V, Djuric Z, Qualls C, Gronert K. Pathway Markers for Pro-resolving Lipid Mediators in Maternal and Umbilical Cord Blood: A Secondary Analysis of the Mothers, Omega-3, and Mental Health Study. Front Pharmacol. 2016 Sep 7;7:274. doi: 10.3389/fphar.2016.00274. eCollection 2016. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | EPA-rich Fish Oil Supplement | EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA |
| FG001 | DHA-rich Fish Oil Supplement | DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA |
| FG002 | Soy Oil Placebo | Soy oil placebo: control arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All intent to treat - (all but lost to follow up) are included in baseline measures
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EPA-rich Fish Oil Supplement | EPA-rich fish oil supplement EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA |
| BG001 | DHA-rich Fish Oil Supplement | DHA-rich fish oil supplement DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Beck Depression Inventory | 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.) | Per protocol analysis is reported here. | Posted | Mean | Standard Deviation | units on a scale | 6 - 8 weeks postpartum |
|
Up to 36 weeks (from enrollment at 12 - 20 weeks gestational age) through 6- 8 weeks after delivery
The population listed as at risk here represents all 42 mothers randomized to each arm, but for NICU admissions and infant jaundice, the denominator (number at risk) represents the number of babies born to the mothers in each arm for whom data were available.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EPA-rich Fish Oil Supplement | EPA-rich fish oil supplement: 1060 mg EPA plus 274 mg DHA |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Premature Delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aftertaste | Gastrointestinal disorders | Systematic Assessment | Aftertaste (sometimes described as fishy, as lemon, as strawberry or just "aftertaste" |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ellen Mozurkewich, Adjunct Assistant Professor | University of Michigan | (734) 546-2772 | emozurkewich@salud.unm.edu |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| DHA-rich fish oil supplement | Drug | 900 mg DHA plus 180 mg EPA |
|
|
| placebo | Drug | control arm |
|
| Gestational Age at Delivery (Weeks) | delivery date was assessed by medical record review between 1 day and 8 weeks after delivery |
| Estimated Blood Loss (ml) | Within 24 hours after delivery |
| Neonatal Birthweight | Mean weight in grams: where <2500 gm is considered small for gestational age and >4500 gm is considered large for gestational age. | immediately after birth |
| NICU (Neonatal Intensive Care Unit) Admissions | Admission to the NICU | 6 weeks post delivery |
| One Minute Apgar Score | 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. | 1 minute after birth |
| Five Minute Apgar Score | 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. | 5 minutes after birth |
| Cord Arterial pH | Arterial blood gas analysis of umbilical cord blood | Immediately after birth (collected within the first hour after delivery) |
| 27485050 | Result | Williams JA, Romero VC, Clinton CM, Vazquez DM, Marcus SM, Chilimigras JL, Hamilton SE, Allbaugh LJ, Vahratian AM, Schrader RM, Mozurkewich EL. Vitamin D levels and perinatal depressive symptoms in women at risk: a secondary analysis of the mothers, omega-3, and mental health study. BMC Pregnancy Childbirth. 2016 Aug 3;16(1):203. doi: 10.1186/s12884-016-0988-7. |
| 23531329 | Result | Romero VC, Somers EC, Stolberg V, Clinton C, Chensue S, Djuric Z, Berman DR, Treadwell MC, Vahratian AM, Mozurkewich E. Developmental programming for allergy: a secondary analysis of the Mothers, Omega-3, and Mental Health Study. Am J Obstet Gynecol. 2013 Apr;208(4):316.e1-6. doi: 10.1016/j.ajog.2013.01.024. |
| 23531328 | Result | Mozurkewich EL, Clinton CM, Chilimigras JL, Hamilton SE, Allbaugh LJ, Berman DR, Marcus SM, Romero VC, Treadwell MC, Keeton KL, Vahratian AM, Schrader RM, Ren J, Djuric Z. The Mothers, Omega-3, and Mental Health Study: a double-blind, randomized controlled trial. Am J Obstet Gynecol. 2013 Apr;208(4):313.e1-9. doi: 10.1016/j.ajog.2013.01.038. |
| 25110470 | Result | Ren J, Mozurkewich EL, Sen A, Vahratian AM, Ferreri TG, Morse AN, Djuric Z. Total Serum Fatty Acid Analysis by GC-MS: Assay Validation and Serum Sample Stability. Curr Pharm Anal. 2013;9(4):331-339. doi: 10.2174/1573412911309040002. |
| 28649675 | Result | Berman D, Clinton C, Limb R, Somers EC, Romero V, Mozurkewich E. Prenatal Omega-3 Supplementation and Eczema Risk among Offspring at Age 36 Months. Insights Allergy Asthma Bronchitis. 2016;2(1):1. doi: 10.21767/2471-304X.100014. Epub 2016 Apr 10. |
| 31783739 | Derived | England JA, Jain J, Holbrook BD, Schrader R, Qualls C, Mozurkewich E. Effect of prenatal EPA and DHA on maternal and cord blood insulin sensitivity: a secondary analysis of the mothers, omega 3, and mental health study. BMC Pregnancy Childbirth. 2019 Nov 29;19(1):452. doi: 10.1186/s12884-019-2599-6. |
| 29940888 | Derived | Mozurkewich EL, Berman DR, Vahratian A, Clinton CM, Romero VC, Chilimigras JL, Vazquez D, Qualls C, Djuric Z. Effect of prenatal EPA and DHA on maternal and umbilical cord blood cytokines. BMC Pregnancy Childbirth. 2018 Jun 26;18(1):261. doi: 10.1186/s12884-018-1899-6. |
| BG002 | Soy Oil Placebo | placebo: control arm |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Gestational age at enrollment | Mean | Standard Deviation | weeks |
|
| Parity | Mean | Standard Deviation | number of previous deliveries |
|
| Past history of depression(self reported) | Number | participants |
|
| BDI (Beck Depression Inventory) score | Beck Depression Inventory contains self-reported answers to questions concerning depression symptoms. It has been validated for use with pregnant women. Minimum score is 0 with 0 as no depression and maximum score is 63 representing the most severe depression. | Mean | Standard Deviation | units on a scale |
|
| EPDS Screen (Edinburgh Prenatal Depression Scale) | The EPDS Screen is self-administered and subsequently scored by researchers on a 0 - 30 point range with 0 as no depression and 30 as most severe. | Mean | Standard Deviation | units on a scale |
|
| OG002 | Soy Oil Placebo | placebo: control arm |
|
|
|
| Other Pre-specified | Maternal Outcomes | 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. | 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. | Posted | Number | participants | 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 |
|
|
|
|
| Other Pre-specified | Gestational Age at Delivery (Weeks) | 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. | Posted | Mean | Standard Deviation | weeks | delivery date was assessed by medical record review between 1 day and 8 weeks after delivery | pregnancies | pregnancies |
|
|
|
|
| Other Pre-specified | Estimated Blood Loss (ml) | Posted | Mean | Standard Deviation | mL | Within 24 hours after delivery |
|
|
|
|
| Other Pre-specified | Neonatal Birthweight | Mean weight in grams: where <2500 gm is considered small for gestational age and >4500 gm is considered large for gestational age. | 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. | Posted | Mean | Standard Deviation | grams | immediately after birth |
|
|
|
|
| Other Pre-specified | NICU (Neonatal Intensive Care Unit) Admissions | Admission to the NICU | One set of twins in group A | Posted | Count of Participants | Participants | 6 weeks post delivery |
|
|
|
|
| Other Pre-specified | One Minute Apgar Score | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 1 minute after birth |
|
|
|
|
| Other Pre-specified | Five Minute Apgar Score | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 5 minutes after birth |
|
|
|
|
| Other Pre-specified | Cord Arterial pH | Arterial blood gas analysis of umbilical cord blood | Umbilical cord gases (pH) were sent at the discretion of the delivering physician and so were not available for all participants. | Posted | Mean | Standard Deviation | pH | Immediately after birth (collected within the first hour after delivery) |
|
|
|
|
| 8 |
| 42 |
| 28 |
| 42 |
| EG001 | DHA-rich Fish Oil Supplement | DHA-rich fish oil supplement: 900 mg DHA plus 180 mg EPA | 5 | 42 | 23 | 42 |
| EG002 | Soy Oil Placebo | Soy oil placebo: control arm | 5 | 42 | 22 | 42 |
| late miscarriage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Preterm premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Neonatal ICU Admission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Maternal ICU admission | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Maternal ICU admission |
|
|
| Belching | Gastrointestinal disorders | Systematic Assessment |
|
| Gestational Diabetes | Endocrine disorders | Systematic Assessment |
|
| Infant Jaundice | Blood and lymphatic system disorders | Systematic Assessment |
|
| Loose stools | Gastrointestinal disorders | Systematic Assessment |
|
| mastitis | Reproductive system and breast disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Preterm Contractions | Reproductive system and breast disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Gestational Diabetes Mellitus |
|
|
| Induced Labor |
|
|
| Cesarean Section |
|
|
| Spontaneous Vaginal Delivery |
|
|
| Operative Vaginal Delivery |
|
|
| .12 |
| Superiority or Other |
| Induced labor | Fisher Exact | .20 | Superiority or Other |
| Cesarean section | Fisher Exact | .08 | Superiority or Other |
| Spontaneous vaginal delivery | Fisher Exact | .88 | Superiority or Other |
| Operative vaginal delivery | Fisher Exact | .32 | Superiority or Other |