Effect of vaginally administered docosahexaenoic acid (DHA) fatty acids on pregnancy outcome
| ISRCTN | ISRCTN39268609 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39268609 |
| Protocol serial number | IRS - 09 - 0001 |
| Sponsor | Italian Society of Prenatal Diagnosis and Fetal Maternal Medicine (S.I.Di.P.) (Italy) |
| Funder | Pharmarte Srl (Italy) |
- Submission date
- 27/05/2009
- Registration date
- 04/08/2009
- Last edited
- 04/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claudio Giorlandino
Scientific
Scientific
Viale Liegi, 45
Rome
00198
Italy
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre double-blind randomised placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of vaginally administered docosahexaenoic acid (DHA) fatty acids on pregnancy outcome: a randomised controlled trial |
| Study objectives | Until today supplementation in pregnancy is performed only with sources consumed per os. Moreover, trials for prevention of premature delivery or low weight baby uses docosahexaenoic acid (DHA) administered orally. The metabolism and absorption of lipids in the gastrointestinal tract is related to a complex pathway involving liver, pancreatic and gastric enzymes. This mechanism could lead to a loss of concentration in the blood that could causes in turn a low effective concentration. The purpose of our study is to assess the efficacy of DHA administered vaginally. |
| Ethics approval(s) | Local Ethics Committee of the "Artemisia Medical Institute Network" (created according to the guidelines reported in the "Decreto Ministeriale (DM) 15/7/1997", Ministry of Health of Italy) on the 11th April 2009 |
| Health condition(s) or problem(s) studied | Low birth weight, preterm labour, hypertension in pregnancy, gestational diabetes |
| Intervention | Iintervention group: vaginally 3 g fish oil (1 g DHA) daily for 20 weeks starting until delivery Control group: vaginally 3 g placebo used as above |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Docosahexaenoic acid (DHA) fatty acids |
| Primary outcome measure(s) |
1. Timing of pregnancy |
| Key secondary outcome measure(s) |
1. Hypertensive disorders |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 60 |
| Key inclusion criteria | All women with a viable foetus between 18+0 and 24+0 weeks of gestation |
| Key exclusion criteria | 1. History of placental abruption 2. Bleeding episode in the present pregnancy 3. Women using (or used) prostaglandin inhibitors 4. Multiple pregnancy 5. Allergy to fish 6. Regular intake of fish oil |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 31/05/2010 |
Locations
Countries of recruitment
- Italy
Study participating centre
Viale Liegi, 45
Rome
00198
Italy
00198
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
