Pregnancy ComplicationsPREPPeDNCT03100084
PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome
An observational study of Pregnancy Complications and Placental Insufficiency, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Complications, Placental Insufficiency
- What is being tested?
- Blood sampling
- How many people
- 1,000 participants
- Where
- 1 siteNorway
- Study dates
- 15 Sep 2016to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Women who do not understand Norwegian or English
- Communicable disease
- Younger than 18 years of age
- Legally incompetent
- Fetal malformations
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0407
Meryam Sugulle, PhD, MD, +4722119800, uxsume@ous-hf.no
Anne Cathrine Staff, PhD, MD, +4722119800, uxnnaf@ous-hf.no
About this study
Official title: The PREPPeD Study: "PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome"
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.
Read the detailed description
The main aim of the PREPPeD study is to explore whether placental health, evaluated by maternal blood biomarkers in late pregnancy, correlates with delivery outcomes in both healthy and complicated pregnancies.
- Conditions
- Pregnancy Complications, Placental Insufficiency
- Being tested
- Blood sampling
- Keywords
- Preeclampsia, Diabetes in Pregnancy, Fetal Growth Restriction, Reduced Fetal Movements
- Medical subject headings
- Pregnancy Complications, Placental Insufficiency, Pre-Eclampsia, Diabetes, Gestational, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Maternal blood sampling
| Study group | Role | What they receive |
|---|---|---|
| I. Post Dates | Pregnant women referred for clinical post term evaluation and/or labour induction.
Blood sampling. Receives: Other: Blood sampling | |
| II. Induction of Labour | Pregnant women ≥37+0 GW (gestational week) referred for labour induction (any cause).
Blood sampling. Receives: Other: Blood sampling | |
| III. All Outpatients | Pregnant women ≥37+0 GW presenting for any medical reason at OUH outpatient clinic.
Blood sampling Receives: Other: Blood sampling | |
| IV. Diabetes in Pregnancy | Pregnant women ≥36+0 GW with pregestational or gestational diabetes. Blood sampling. Receives: Other: Blood sampling | |
| V. Reduced Fetal Movements | Pregnant women ≥37+0 GW with reduced fetal movements and/or referred due to reduced symphysis-fundal height.
Blood sampling. Receives: Other: Blood sampling | |
| VI. Hypertensive Disorders in Pregnancy | Pregnant women referred for preeclampsia (or other pregnancy induced hypertensive disorders) and/or suspected fetal growth restriction; longitudinal cohorts.
Blood sampling. Receives: Other: Blood sampling | |
| VII. All Labour Admissions | All pregnant women ≥37+0 GW admitted for labour. Blood sampling. Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal acidaemia
In neonates delivered by cesarean section (CS) without labour (defined as absence of regular uterine contractions):
Umbilical artery blood (transporting blood from the fetus to the placenta) pH<7.13 and arterial BD >10.0
In neonates from labored delivery (regardless of subsequent delivery method, vaginal or CS):
Umbilical artery blood pH<7.05 and arterial BD>14; OR Umbilical artery blood (or venous if arterial blood not available) lactate above Reference level for respective gestational age according to publication by Wiberg N et al ,BJOG 2008 (doi: 10.1111/j.1471-0528.2008.01707.x.)
Measured: Umbilical cord gas/lactate are sampled directly post partum within 45 min; data assessed throughout study period of 140 months
Newborn low Apgar score
<4 at 1 minute OR <7 at 5 minutes
Measured: Apgar score is assessed directly post partum within 10 minutes; data assessed throughout study period of 140 months
Newborn asphyxia
Combination of outcomes 1 and 2
Measured: 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
Measured: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Neonatal intubation/mechanical ventilation>6 hours
Measured: Within 28 days postpartum; data assessed throughout study period of 140 months
Meconium aspiration syndrome
Measured: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Neonatal hypoxic-ischemic encephalopathy
Measured: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Therapeutic hypothermia of the neonate
Measured: Within 3 days postpartum; data assessed throughout study period of 140 months
Rate of acute cesarean section (due to suspected fetal distress)
Measured: Data assessed throughout study period of 140 months
Secondary outcomes (3)
Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress)
Measured: Data assessed throughout study period of 140 months
Pathological placenta histology findings
Measured: Data assessed throughout study period of 140 months
Abnormal intrapartum CTG patterns
Measured: Intrapartum CTG; data assessed throughout study period of 140 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start15 Sep 2016
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy ComplicationsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian SIDS and Stillbirth Society, Extrastiftelsen
- Responsible party
- Principal investigator, Meryam Sugulle, Oslo University Hospital
- Investigators
- Meryam Sugulle, PhD, MD, Principal investigator, Oslo University Hospital, Department of Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100084
- Sponsor's protocol ID
- 36864
- Other IDs
- 36259
- Acronym
- PREPPeD
- Status last verified
- Dec 2020
- First submitted
- 21 Mar 2017
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Depending on when the permission for the dataset usage for the project's outcome measures ends (OUH personal data officer/Regional Ethical Comittee) AND Norwegian legislation regarding personal data protection. It is unlikely that a major part of the data set will be shared openly due to these restrictions on sensitive personal data matters.
Publications
Mitlid-Mork B, Turowski G, Bowe S, Staff AC, Sugulle M. Circulating angiogenic profiles and histo-morphological placental characteristics of uncomplicated post-date pregnancies. Placenta. 2021 Jun;109:55-63. doi: 10.1016/j.placenta.2021.04.017. Epub 2021 May 5.
PubMed 33990027
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PREPPeD Study: "PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome"
- ClinicalTrials.gov ID
- NCT03100084
- Acronym / sponsor ID
- PREPPeD / 36864
- Conditions
- Pregnancy Complications, Placental Insufficiency
- Keywords
- Preeclampsia, Diabetes in Pregnancy, Fetal Growth Restriction, Reduced Fetal Movements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian SIDS and Stillbirth Society, Extrastiftelsen
- Study start
- 15 Sep 2016 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The main aim of the PREPPeD study is to explore whether placental health, evaluated by maternal blood biomarkers in late pregnancy, correlates with delivery outcomes in both healthy and complicated pregnancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| I. Post Dates | – | Other: Blood samplingPregnant women referred for clinical post term evaluation and/or labour induction. Blood sampling. |
| II. Induction of Labour | – | Other: Blood samplingPregnant women ≥37+0 GW (gestational week) referred for labour induction (any cause). Blood sampling. |
| III. All Outpatients | – | Other: Blood samplingPregnant women ≥37+0 GW presenting for any medical reason at OUH outpatient clinic. Blood sampling |
| IV. Diabetes in Pregnancy | – | Other: Blood samplingPregnant women ≥36+0 GW with pregestational or gestational diabetes. Blood sampling. |
| V. Reduced Fetal Movements | – | Other: Blood samplingPregnant women ≥37+0 GW with reduced fetal movements and/or referred due to reduced symphysis-fundal height. Blood sampling. |
| VI. Hypertensive Disorders in Pregnancy | – | Other: Blood samplingPregnant women referred for preeclampsia (or other pregnancy induced hypertensive disorders) and/or suspected fetal growth restriction; longitudinal cohorts. Blood sampling. |
| VII. All Labour Admissions | – | Other: Blood samplingAll pregnant women ≥37+0 GW admitted for labour. Blood sampling. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- Women who do not understand Norwegian or English
- Communicable disease
- Younger than 18 years of age
- Legally incompetent
- Fetal malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingMaternal blood sampling | Other | I. Post Dates, II. Induction of Labour, III. All Outpatients, IV. Diabetes in Pregnancy, V. Reduced Fetal Movements, VI. Hypertensive Disorders in Pregnancy, VII. All Labour Admissions |
Primary outcome
Fetal acidaemia
Time frame: Umbilical cord gas/lactate are sampled directly post partum within 45 min; data assessed throughout study period of 140 months
In neonates delivered by cesarean section (CS) without labour (defined as absence of regular uterine contractions): Umbilical artery blood (transporting blood from the fetus to the placenta) pH<7.13 and arterial BD >10.0 In neonates from labored delivery (regardless of subsequent delivery method, vaginal or CS): Umbilical artery blood pH<7.05 and arterial BD>14; OR Umbilical artery blood (or venous if arterial blood not available) lactate above Reference level for respective gestational age according to publication by Wiberg N et al ,BJOG 2008 (doi: 10.1111/j.1471-0528.2008.01707.x.)
Newborn low Apgar score
Time frame: Apgar score is assessed directly post partum within 10 minutes; data assessed throughout study period of 140 months
<4 at 1 minute OR <7 at 5 minutes
Newborn asphyxia
Time frame: Directly post partum within 10 and 45 minutes respectively; data assessed throughout study period of 140 months
Combination of outcomes 1 and 2
Rate of intrauterine fetal demise/intra-/postpartum fetal death
Time frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Neonatal intubation/mechanical ventilation>6 hours
Time frame: Within 28 days postpartum; data assessed throughout study period of 140 months
Meconium aspiration syndrome
Time frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Neonatal hypoxic-ischemic encephalopathy
Time frame: Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Therapeutic hypothermia of the neonate
Time frame: Within 3 days postpartum; data assessed throughout study period of 140 months
Rate of acute cesarean section (due to suspected fetal distress)
Time frame: Data assessed throughout study period of 140 months
3 secondary outcomes
Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress)
Time frame: Data assessed throughout study period of 140 months
Pathological placenta histology findings
Time frame: Data assessed throughout study period of 140 months
Abnormal intrapartum CTG patterns
Time frame: Intrapartum CTG; data assessed throughout study period of 140 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 33990027Mitlid-Mork B, Turowski G, Bowe S, Staff AC, Sugulle M. Circulating angiogenic profiles and histo-morphological placental characteristics of uncomplicated post-date pregnancies. Placenta. 2021 Jun;109:55-63. doi: 10.1016/j.placenta.2021.04.017. Epub 2021 May 5.
- Individual participant dataSharing planned: Undecided. Depending on when the permission for the dataset usage for the project's outcome measures ends (OUH personal data officer/Regional Ethical Comittee) AND Norwegian legislation regarding personal data protection. It is unlikely that a major part of the data set will be shared openly due to these restrictions on sensitive personal data matters.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meryam Sugulle, PhD, MD principal investigator
Oslo University Hospital, Department of Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complications and Placental Insufficiency, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meryam Sugulle, PhD, MD (+4722119800, uxsume@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal acidaemia (time frame: Umbilical cord gas/lactate are sampled directly post partum within 45 min; data assessed throughout study period of 140 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03100084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.