A pilot study of antenatal maternally administered melatonin to decrease the level of oxidative stress in human pregnancies affected by preeclampsia (PAMPR Trial).
A pilot study of antenatal maternally administered melatonin in human pregnancies affected by preterm preeclampsia to prolong pregnancy.
Monash Health Research Directorate
20 participants
Aug 26, 2013
Interventional
Conditions
Summary
This research project will investigate whether the hormone, Melatonin, is a useful treatment for oxidative stress in pregnancies affected by preeclampsia. Preeclampsia is one of the most common diseases in pregnancy and is potentially very dangerous for both mother and baby. Oxidative stress in preeclampsia occurs when a pregnant mother and the baby in the womb are exposed to certain noxious chemicals produced by the placenta. Oxidative stress can cause serious damage to the mother and baby, including premature birth, brain damage and even death. Melatonin is a strong antioxidant and is been used to effectively treat oxidative stress in pre-clinical trials. It has also been studied intensively in both animals and humans and has shown to be very safe. In this trial, we hope to use melatonin to reduce the damage caused by oxidative stress during pregnancies affected by preeclampsia. To do this, we will give mothers diagnosed with preeclampsia melatonin (10mg) tablets three times a day. We will measure levels of oxidative stress before, during and after treatment in the mother's blood, as well as in blood from the placenta after birth. Other non-invasive measurements of mother and baby health will also be measured including the outcome of their pregnancies. This will give us an indication whether melatonin is helping to protect the unborn baby from oxidative stress. Participation in this project will be undertaken during the normal care of a woman with preeclampsia admitted to hospital. She will be cared for in the usual way with best practice and there will be regular blood samples twice per week as is normally done. Ultrasound scans to check the health of the baby will be done at least weekly. Samples will be taken from the maternal blood or from material that would normally be discarded. No samples will be obtained directly from the baby. If this project is successful, it will potentially give us the very first and only treatment for preeclampsia.
Eligibility
Inclusion Criteria9
- Be at least 18 years of age.
- Be between 24+0 weeks’ and 35+6 weeks’ gestation.
- Have a singleton pregnancy.
- Have a diagnosis of Preeclampsia.
- Be considered capable of safely continuing the pregnancy for 48 hours or more, as determined by the attending clinician.
- Obstetrician and neonatologist believe the fetus is likely to be viable.
- 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.
- Be capable of understanding the information provided, with use of an interpreter if required.
- Give written informed consent.
Exclusion Criteria14
- Eclampsia.
- Current use of melatonin.
- Contraindications to melatonin use including:
- a. Hypersensitivity to melatonin or any of its derivatives.
- Imminent transfer to a non-trial centre due to unavailability of neonatal beds.
- Significant uncertainty regarding gestational age.
- Women to be treated as an outpatient.
- Use of any of the following medications:
- a. Fluvoxamine.
- b. 5- or 8-Methoxypsoralen.
- c. Cimetidine.
- d. Quinolones and other CYP1A2 inhibitors.
- e. Carbamazepine, rifampicin and other CYP1A2 inducers.
- f. Zaleplon, zolpidem, zopiclone and other non-benzodiazepine hypnotics.
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Interventions
Oral melatonin sustained release tablet 10mg administered three-times-daily. Duration is from recruitment to delivery. Adherence will be monitored through utilisation of hospital inpatient drug prescription charts for the entire duration of the trial.
Locations(2)
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ACTRN12613000476730