UnknownNot Applicable

PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome

Norway1,000 participantsStarted 2016-09-15

Plain-language summary

The PREPPeD study proposes that predelivery placenta-derived maternal circulating biomarkers reflect placental health, capacity and ageing, and can help predict onset and complications of delivery both in complicated pregnancies as well as in clinically uncomplicated term/post-term pregnancies.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All pregnant women scheduled to deliver at the Department of Obstetrics at OUH who qualify for the study groups as specified in the "Groups and Intervention" section. Exclusion Criteria: * Women who do not understand Norwegian or English * Communicable disease * Younger than 18 years of age * Legally incompetent * Fetal malformations

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Fetal acidaemia

Timeframe: Umbilical cord gas/lactate are sampled directly post partum within 45 min; data assessed throughout study period of 140 months

Newborn low Apgar score

Timeframe: Apgar score is assessed directly post partum within 10 minutes; data assessed throughout study period of 140 months

Newborn asphyxia

Timeframe: Directly post partum within 10 and 45 minutes respectively; data assessed throughout study period of 140 months

Rate of intrauterine fetal demise/intra-/postpartum fetal death

Timeframe: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months

Neonatal intubation/mechanical ventilation>6 hours

Timeframe: Within 28 days postpartum; data assessed throughout study period of 140 months

Meconium aspiration syndrome

Timeframe: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months

Trial details

NCT IDNCT03100084

SponsorOslo University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09-01

Contact for this trial

Meryam Sugulle, PhD, MD

+4722119800 uxsume@ous-hf.no

View on ClinicalTrials.gov More Pregnancy Complications trials

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Fetal acidaemia

Timeframe: Umbilical cord gas/lactate are sampled directly post partum within 45 min; data assessed throughout study period of 140 months

Newborn low Apgar score

Timeframe: Apgar score is assessed directly post partum within 10 minutes; data assessed throughout study period of 140 months

Newborn asphyxia

Timeframe: Directly post partum within 10 and 45 minutes respectively; data assessed throughout study period of 140 months

Rate of intrauterine fetal demise/intra-/postpartum fetal death

Timeframe: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months

Neonatal intubation/mechanical ventilation>6 hours

Timeframe: Within 28 days postpartum; data assessed throughout study period of 140 months

Meconium aspiration syndrome

Timeframe: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months