RecruitingACTRN12618000266268

A comparative study looking at the prevalence of human papilloma virus (HPV) and HPV types in term and preterm labour cases by testing placentae, high vaginal swabs and maternal blood (cfDNA) (HIPPOP trial).

A case control study to determine the prevalence of HPV in preterm labour and preterm prelabour rupture of membranes, the association between HPV and these clinical presentations, and the potential immunological processes underlying preterm labour


Sponsor

University of Otago

Enrollment

200 participants

Start Date

Jan 30, 2016

Study Type

Observational

Conditions

Summary

The HIPPOP study is a case control study conducted at the University of Otago, Dunedin School of Medicine, Depts. of Women’s and Children’s Health and Pathology, to determine the prevalence of human papillomavirus (HPV) in the blood, placenta and cervix of women presenting in preterm labour (PTL) or preterm prelabour rupture of membranes (PPROM), and the association between placental HPV infection and PTL and PPROM. Overall, it will attempt to determine if placental HPV infection plays a role in preterm labour, raising the possibility of prediction of risk, and/or screening for PTL, and development of treatment to reduce the incident or prevent preterm labour.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a virus called human papillomavirus (HPV) found in the placenta might play a role in causing premature birth. Premature birth is a major cause of newborn illness and death. Researchers will test placentas, vaginal swabs, and blood samples from women who go into labour early (preterm) and compare them with women who deliver at term. If HPV is linked to preterm birth, it may be possible in the future to screen for it and develop treatments to prevent premature labour. You may be eligible if: - You are a pregnant woman aged 18 or older - You are in labour or threatened labour at any time in your second or third trimester - You are being induced at term for routine reasons (e.g. post-dates, social reasons) - You have a history of preterm birth or shortened cervix You may NOT be eligible if: - You are under 18 years old - You are being induced or having an emergency caesarean due to concerns about your baby or your own health (e.g. growth restriction, pre-eclampsia) - You are having an elective (planned) caesarean section - You are carrying twins or more, or have a known uterine abnormality Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Condition investigated is preterm labour (PTL) and premature preterm rupture of membranes (PPROM) and its association with HPV. We are looking at women who go into labour before 37 weeks gestation or

Condition investigated is preterm labour (PTL) and premature preterm rupture of membranes (PPROM) and its association with HPV. We are looking at women who go into labour before 37 weeks gestation or experience PPROM before 37 weeks gestation (even if delivery is over 37 weeks gestation). The final mode of delivery does not matter and we do not follow them afterward. The samples required include high vaginal swab, maternal blood test, and placental sample. The blood and swab are collected during labour, while the placental sample is collected soon after birth.


Locations(1)

Otago/Southland, New Zealand

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