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Pilot study of DEHP and BPA exposure during and after delivery, in mother and child

Pilot study of DEHP and BPA exposure during and after delivery, in mother and child - DeBeD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41697
Enrollment
30
Registered
2014-06-20
Start date
2015-01-22
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

exposure plasticisers

Interventions

None listed

Sponsors

Westfries Gasthuis
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. uncomplicated pregnancy 2. informed written consent

Exclusion criteria

Exclusion criteria: 1. Complications during the pregnancy or delivery (serious infections, asphyxia, serious congenital malformations) 2. No written informed consent for participation 3. Underlying medical condition whereby regular interventions with medical devices is required, e.g. dialysis 4. Non-singleton pregnancy

Design outcomes

Primary

MeasureTime frame
1. The ambient concentrations in the home, delivery room and operating theatre will be measured using standard dust and ambient air sampling systems. 2. The DEHP and BPA levels in the urine samples of the mothers and newborn babies, and in the amniotic fluid and meconium samples will be analysed in the laboratory of the Institute for Environmental Studies (IVM), VU University, De Boelelaan 1105, 1081 HV Amsterdam, Netherlands. 3. The samples will be collected in glass containers and the neonatal urine will be collected using a DEHP- and BPA-free urine collection bags.

Secondary

MeasureTime frame
The registration forms of the medical apparatus used during the delivery will be correlated to the DEHP and BPA exposures in the mothers and newborns. All medical devices used, including make and type, will be noted by the attending nurse. Examples include intravenous catheters, intubation and ventilation equipment, epidural catheters, breast milk expressing equipment, etc. Due to the fact that DEHP is rapidly metabolised in the human body, it is not necessary to correct for exposures prior to the time of delivery.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)