The effects of melatonine in high risk pregnant women receiving enoxaparin and aspirin

The effects of melatonine on the levels of oxidative stress and inflammatory markers in high risk pregnant women receiving enoxaparin and aspirin

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210608051518N1

Enrollment

Registered

2021-12-22

Start date

2022-01-05

Completion date

Unknown

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High risk pregnant women receiving prophylaxis enoxaparin and aspirin. Encounter for supervision of other normal pregnancy

Interventions

Intervention 1: Intervention group: Two 3-mg melatonin tablets per day, 1 h before bedtime for 20 weeks, made by Nature Made, USA with 40 mg daily enoxaparin and 80 mg daily aspirin. Intervention 2: C

Eligibility

Sex/Gender

Female

Age

15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Pregnant women 15 to 45 years old Gestational age between 6 to16 weeks BMI more than 25 kg/m2 Start of taking anticoagulants and aspirin from the first half of pregnancy

Exclusion criteria

Exclusion criteria: Patients with diabetes mellitus receiving insulin or oral tablets Chronic metabolic diseases Anemia Smokers and alcoholics Use of other dietary supplements, probiotics and anti-inflammatory drugs Use of any antioxidant supplements in the last 3 months Use of immunosuppressive drugs Following of special diets History of taking OCP pills Twin pregnancies or more Gestational hypertension and diabetes

Design outcomes

Primary

Measure	Time frame
C-reactive protein. Timepoint: Before and after the intervention. Method of measurement: ELISA.	—

Secondary

Measure	Time frame
Total antioxidant capacity. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Malondialdehyde (MDA). Timepoint: Before and after the intervention. Method of measurement: ELISA.;Nitric oxide metabolites. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Sulfhydryl protein. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Baby head circumference. Timepoint: After the delivery. Method of measurement: Tape meter.;Baby height. Timepoint: After the delivery. Method of measurement: Digital scales.;Baby weight. Timepoint: After the delivery. Method of measurement: Digital scales.	—

Measure

Time frame

Total antioxidant capacity. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Malondialdehyde (MDA). Timepoint: Before and after the intervention. Method of measurement: ELISA.;Nitric oxide metabolites. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Sulfhydryl protein. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Baby head circumference. Timepoint: After the delivery. Method of measurement: Tape meter.;Baby height. Timepoint: After the delivery. Method of measurement: Digital scales.;Baby weight. Timepoint: After the delivery. Method of measurement: Digital scales.

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Countries

Iran (Islamic Republic of)

Contacts

Public Contact?Dr. Roghaye Porhemmat

Yasouj University of Medical Sciences

roghiporhemmat@yahoo.com+98 74 3334 6078

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026