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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618000266268

Acronym

HIPPOP trial

Enrollment

140

Registered

2018-02-21

Start date

2016-01-30

Completion date

2018-06-30

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 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

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

- Maternal age over 18 years at the time of consent. - Women in labour or threatened labour at any time during their second and third trimesters. - Induction of labour at term or post dates for reasons other than concerns for mother or baby, including but not limited to postdates state, social reasons, and previous assisted delivery and/or perineal tear. - Women presenting with PTL and need to undergo caesarean section due to previous caesarean section. - Women with previous PTL or PPROM. - Women with shortened cervical length, with or without progesterone treatment, and those with diagnosis of cervical incompetence.

Exclusion criteria

- Women under 18 years of age at the time of consent. - Iatrogenic delivery for maternal or fetal concerns, for example emergency caesarean section or induction of labour (IOL) for a baby with restricted growth and abnormal blood supply (=IUGR baby with abnormal dopplers), or maternal pre-eclamplsia. - Women undergoing elective caesarean section. - Women with multiple pregnancy, or known uterine anomalies.

Outcome results