Clinical trial NCT01990690: Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial
Official title: Role of Antioxidants in Unexplained Oligohydramnios,A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oilgohydramnios
Keywords: oligohydramnios,antioxidant,oxidative stress and pregnancy outcomes
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2013-11-21
Enrollment: 202
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To predict the effect of antioxidants in cases of oligohydramnios

Detailed description: 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:

1. To study the effect of antioxidants in cases of oligohydramnios.
2. To study the effect of antioxidants on mode of delivery and neonatal outcome.
3. To commence special recommendations from the study about the use of antioxidants in cases of oligohydramnios of unknown cause and cases of oligohydramnios associated with pregnancy induced hypertension.

Inclusion criteria:

Patients with gestational age between 30-34 weeks with:

* Oligohydramnios of unknown cause.
* Oligohydramnios assosiatd with Pregnancy induced hypertension (PIH).

Exclusion criteria:

1. Premature rupture of membranes.
2. Oligohydramnios in postdates pregnancy (\>41 weeks).
3. Fetal anomalies.
4. IUGR.
5. Patients using non steroidal anti-inflammatory drugs.

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:

* Fish oil (30) % (Eicosapentaenoic acid (EPA) 18 % / Docosahexaenoic acid (DHA) 12 % ) natural source of Omega 3 Fatty acids.
* Wheat germ oil (Tocopherol: N.N.T. 0.22 %) which is rich and natural source of Vitamin E (protects the oils from oxidation. besides its well known that requirements of vitamin E increases with increased dietary amounts of polyunsaturated fatty acids).

Eligibility criteria: Inclusion Criteria:

* Patients with gestational age between 30-34 weeks with:
* Oligohydramnios of unknown cause.

Exclusion Criteria:

* 1- Premature rupture of membranes. 2- Oligohydramnios in postdates pregnancy (\>41 weeks). 3- Fetal anomalies. 4- IUGR. 5- Patients using non steroidal anti-inflammatory drugs. 6 - Oligohydramnios assosiatd with Pregnancy induced hypertension (PIH).

Primary outcomes:
measure: improvement of amniotic fluid index
timeFrame: 4 weeks
Secondary outcomes:
measure: The changes in Doppler resistance index
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women's Health Hospital
Study officials:
affiliation: Women's Health Hospital
name: Alaa M Ismail, M D
role: PRINCIPAL_INVESTIGATOR
References: