Predicting Adverse Pregnancy Outcomes (PAPO) Study: An observational study to determine factors in both male and female partners to predict healthy pregnancies and adverse pregnancy outcomes

Not Applicable

Recruiting

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

• Registration Number: ACTRN12609000254291
• Lead Sponsor: ational Health and Medical Research Council (NHMRC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Recruit before 12 weeks gestation, Consent to participate

Exclusion Criteria

Serious medical illness, lack of informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pregnancy outcome data will be collected from the volunteers medical records[At the end of delivery or pregnancy loss]

Secondary Outcome Measures

Name	Time	Method
Deoxyribonucleic acid (DNA) damage levels will be measured in lymphocytes using the cytokinesis block micronucleus (CBMN) assay.[One time point before pregnancy (the couple must be actively trying to get pregnant) and at 12 weeks gestation];Blood concentrations of folate, vitamin 12, homocysteine and enzyme polymorphisms within folate metabolism. These tests will be done by SA pathology using routine laborarty tests.[One time point before pregnancy (the couple must be actively trying to get pregnant) and at 12 weeks gestation]