The effect of melatonin in the prevention of preeclampsia
Phase 2
Recruiting
- Conditions
- Preeclampsia.Unspecified pre-eclampsiaO14.9
- Registration Number
- IRCT20230930059563N1
- Lead Sponsor
- Kashan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.