PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome

Pregnancy Complications Clinical Trial

— PREPPeD  

Official title:

The PREPPeD Study: "PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03100084
• Other study ID #: 36864
• Secondary ID: 36259
• Status: Recruiting
• Start date: September 15, 2016
• Est. completion date: September 1, 2022

Study information

• Verified date: December 2020
• Source: Oslo University Hospital
• Contact: Meryam Sugulle, PhD, MD
• Phone: +4722119800
• Email: uxsume[@]ous-hf.no
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Placental Insufficiency
• Pregnancy Complications

Intervention

Other:
• Blood sampling
Maternal blood sampling

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Extrastiftelsen, Norwegian SIDS and Stillbirth Society

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	Umbilical cord gas/lactate are sampled directly post partum within 45 min; data assessed throughout study period of 140 months
Primary	Newborn low Apgar score	<4 at 1 minute OR <7 at 5 minutes	Apgar score is assessed directly post partum within 10 minutes; data assessed throughout study period of 140 months
Primary	Newborn asphyxia	Combination of outcomes 1 and 2	Directly post partum within 10 and 45 minutes respectively; data assessed throughout study period of 140 months
Primary	Rate of intrauterine fetal demise/intra-/postpartum fetal death		Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Primary	Neonatal intubation/mechanical ventilation>6 hours		Within 28 days postpartum; data assessed throughout study period of 140 months
Primary	Meconium aspiration syndrome		Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Primary	Neonatal hypoxic-ischemic encephalopathy		Diagnosis within 28 days postpartum; data assessed throughout study period of 140 months
Primary	Therapeutic hypothermia of the neonate		Within 3 days postpartum; data assessed throughout study period of 140 months
Primary	Rate of acute cesarean section (due to suspected fetal distress)		Data assessed throughout study period of 140 months
Secondary	Rates of operative vaginal deliveries (forceps/vacuum/combined; due to suspected fetal distress)		Data assessed throughout study period of 140 months
Secondary	Pathological placenta histology findings		Data assessed throughout study period of 140 months
Secondary	Abnormal intrapartum CTG patterns		Intrapartum CTG; data assessed throughout study period of 140 months