Preeclampsia. Unspecified pre-eclampsia
Conditions
Interventions
Intervention 1: Intervention group: Aspirin + melatonin. Intervention 2: Control group: Aspirin.
Sponsors
Kashan University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 16 years and older 12-28 weeks of pregnancy moderate to high risk of preeclampsia based on US Preventive Services Task Force criteria informed consent
Exclusion criteria
Exclusion criteria: Multiple pregnancy Current or previous use of melatonin in the past 6 weeks Allergy to melatonin and aspirin Use of any of the following drugs that can interfere with the metabolism and/or elimination of melatonin: fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, quinolones, and other CYP1A2 inhibitors. Carbamazepine, rifampicin and other CYP1A2 inducers. and zalplon, zolpidem, zopiclone, and other non-benzodiazepine hypnotics. lose to follow-up non cooperate The presence of any disease or condition that is a contraindication for continued pregnancy Fetal anomaly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of preeclampsia. Timepoint: The time interval until the occurrence of pre-eclampsia or termination of pregnancy, whichever is earlier. Method of measurement: Based on clinical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Type of delivery. Timepoint: Once upon a time. Method of measurement: clinical basis.;Neonate Apgar. Timepoint: Once at the moment of the birth. Method of measurement: Based on the Apgar scoring system.;Newborn characteristics (height-weight). Timepoint: Once at the moment of the birth. Method of measurement: Based on the standard method of measuring the height and weight of the baby. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMozhgan Alishahi
Kashan University of Medical Sciences
Outcome results
None listed