Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To predict the effect of antioxidants in cases of oligohydramnios
Type of study:
This is a prospective randomized controlled study that was done in department of obstetrics and gynecology of Assiut University Hospital.
Aim of the work:
Inclusion criteria:
Patients with gestational age between 30-34 weeks with:
Exclusion criteria:
Assessment of the patients:
The target population was assessed to find the participating women suitable for the study, this assessment was done to verify inclusion criteria and to exclude any women has any of the exclusion criteria.
Ultrasongraphic evaluation:
Ultrasongraphy was done for estimation of amniotic fluid index by measuring the vertical diameter of the pockets of amniotic fluid in four sections of the uterus and add them together. This gives them a number known as amniotic fluid index (AFI). If the AFI is less than 5 centimeters, the pregnant woman has oligohydramnios
Composition of omega-3 plus:
Soft gelatineous capsule (Sedico medical company) each capsule contains:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti oxidant omega 3 | Active Comparator | The patients were randomized to receive either a daily dose of omega-3 plus as antioxidant once daily for two weeks or a daily placebo then stored in envelopes numbered from 1 to 140 |
|
| placebo | Placebo Comparator | Group 1 was given omega -3 plus (Sedico medical company) as antioxidant once daily for two weeks. Group 2 was given a placebo once daily for two weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti oxidant omega 3 | Drug | Soft gelatineous capsule (Sedico medical company) each capsule contains:
Group 1 was given omega -3 plus (Sedico medical company) as antioxidant once daily for two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| improvement of amniotic fluid index | Treatment was started immediately and continued for two weeks. The patients were randomized to receive either a daily dose of omega-3 plus as antioxidant once daily for two weeks or a daily placebo then stored in envelopes numbered from 1 to 140. The envelopes were numbered and randomized according to computer-generated randomization tables to ensure an equal number of patients in each arm. Throughout the trial, access to the randomization code was available only to the pharmacist who manufactured the placebo and packed the envelopes and was not available to any of the treating physicians or patients. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in Doppler resistance index | The resistance index is measured in the uterine and umbilical artery by ultrasound | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alaa M Ismail, M D | Women's Health Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Health Hospital | Asyut | Egypt |
Not provided
| ID | Term |
|---|---|
| D016104 | Oligohydramnios |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |