A pilot study of antenatal maternally administered melatonin to decrease the level of oxidative stress in human pregnancies affected by preeclampsia (PAMPR Trial).

Phase 1

Completed

• Conditions: Preeclampsia; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12613000476730
• Lead Sponsor: Monash Health Research Directorate

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

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.
c. Cimetidine.
d. Quinolones and other CYP1A2 inhibitors.
e. Carbamazepine, rifampicin and other CYP1A2 inducers.
f. Zaleplon, zolpidem, zopiclone and other non-benzodiazepine hypnotics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified