ACTRN12613000476730
Completed
Phase 1
A pilot study of antenatal maternally administered melatonin in human pregnancies affected by preterm preeclampsia to prolong pregnancy.
Monash Health Research Directorate0 sites20 target enrollmentApril 30, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Monash Health Research Directorate
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Be at least 18 years of age.
- •2\. Be between 24\+0 weeks’ and 35\+6 weeks’ gestation.
- •3\. Have a singleton pregnancy.
- •4\. Have a diagnosis of Preeclampsia.
- •5\. Be considered capable of safely continuing the pregnancy for 48 hours or more, as determined by the attending clinician.
- •6\. Obstetrician and neonatologist believe the fetus is likely to be viable.
- •7\. No major anomalies evident on the mid\-trimester morphology scan. Any anomaly should be assessed by the Principal Investigator and discussed with the Trial Supervisor, following classification of the anomaly according to the ICD10 codes. All major anomalies will be excluded, but minor anomalies, subject to agreement between the PI and Trial Supervisor will be included.
- •8\. Be capable of understanding the information provided, with use of an interpreter if required.
- •9\. Give written informed consent.
Exclusion Criteria
- •1\. Eclampsia.
- •2\. Current use of melatonin.
- •3\. Contraindications to melatonin use including:
- •a. Hypersensitivity to melatonin or any of its derivatives.
- •4\. Imminent transfer to a non\-trial centre due to unavailability of neonatal beds.
- •5\. Significant uncertainty regarding gestational age.
- •6\. Women to be treated as an outpatient.
- •7\. Use of any of the following medications:
- •a. Fluvoxamine.
- •b. 5\- or 8\-Methoxypsoralen.
Outcomes
Primary Outcomes
Not specified
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