Pregnancy; Pre-eclampsia, MildMAPNCT02373839
Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia
A study testing Measurement of PlGF in people with Pregnancy; Pre-eclampsia, Mild, run by Fetal Medicine Research Center, Spain at 1 site in Spain.
Trial summary
Preeclampsia is an important disease that develops during pregnancy and it is one of the main contributors to maternal and fetal complications. The only known definitive treatment is delivery. Although delivery is always appropriate for the mother, it might not be the best for a very premature neonate. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy; Pre-eclampsia, Mild
- What is being tested?
- Measurement of PlGF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to Dec 2019
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > or = 18 years
- pregnant women with non-severe preeclampsia
- gestational age between 34 and 36.5 weeks
Who cannot join
- No exclusion criteria are defined (intention-to-treat analysis)
Trial locations and contacts
1 site in 1 country.
Estefania Callado contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona - Maternitat (BCNatal)
Barcelona, 08036
Estefania Callado, ecallado@clinic.ub.es
Francesc Figueras
About this study
Official title: Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia, a Randomized Study
Preeclampsia is an important disease that develops during pregnancy and it is one of the main contributors to maternal and fetal complications.
The only known definitive treatment is delivery. Although delivery is always appropriate for the mother, it might not be the best for a very premature neonate.
Read more
In cases of non-severe preeclampsia there no benefit delaying delivery beyond 37 weeks. It is also well established that before 34 weeks an expectant management confers perinatal benefit with minimum amount of additional maternal risk. There is then an area of uncertainty between 37 and 37 weeks. This is why in this period it is a clinical need to select high risk patients of complications that will benefit from labor induction, and differentiate them from low risk patients that can be manage expectantly until 37 weeks.
Placental growth factor (PlGF) is an angiogenic factor that is lower in pregnant women with preeclampsia and current evidence shows that it as a predictor of adverse pregnancy outcome and requirement of delivery.
Circulating levels of PIGF at 34 weeks could help to identify those women that may benefit from labor induction and those where delivery can be delayed until 37 weeks with low risk for maternal complications.
Read the detailed description
BACKGROUND
The current definition of pre-eclampsia is a new onset hypertension (>140/90mmHg) and proteinuria (>0'3g per 24 hours) after 20 weeks of gestation. Pre-eclampsia affects 3% to 8% of all pregnancies and it is a leading cause of maternal and neonatal morbidity and mortality.
It has been subclassified by clinical severity in severe and non-severe and by gestational age at the diagnosis in early and late onset pre-eclampsia (>34 weeks of gestation).
Pre-eclampsia is associated with abnormal placentation and uterine angiogenesis. Pregnant women with preeclampsia show lower circulating levels of placental growth factor (PlGF), a proangiogenic factor related to placental angiogenesis, compared with healthy pregnant women. Moreover evidence has been found regarding the role of PlGF as a predictor of adverse pregnancy outcome and requirement of delivery.
The only definitive treatment of the disease is delivery. In patients with non-severe preeclampsia between 34 and 37 weeks there is no consensus regarding the ideal time of delivery.
AIM: The aim of this study is to assess whether circulating levels of PIGF at 34 weeks could help to identify those women that may benefit from labor induction and those where delivery can be delayed until 37 weeks with low risk for maternal complications.
- Conditions
- Pregnancy; Pre-eclampsia, Mild
- Being tested
- Measurement of PlGF
- Medical subject headings
- Pre-Eclampsia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of PlGFOther
If lower than 100 pg/mL labour will be inducted at the moment of diagnosis. Otherwise standard monitoring will be done with labour induction at 37 weeks
| Study group | Role | What they receive |
|---|---|---|
| PlGF measurement | Other | Determination of PlGF levels. If lower than 100 pg/mL labour will be inducted at the moment of diagnosis. Otherwise standard monitoring will be done with labour induction at 37 weeks. Receives: Other: Measurement of PlGF |
| Controls | No intervention | induction of labour at 37 weeks of gestation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of maternal complications
Maternal complications as HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), pulmonary oedema, severe hypertension, eclampsia, thromboembolic disease...
Measured: gestational age between 34 and 36.5 weeks
Composite of neonatal morbidity
Verma A J Epidemiol Communitary Health 2005 Score
Measured: 2 weeks
Secondary outcomes (4)
maternal risk at induction
according to PIERs score
Measured: 1 day
Average length of maternal hospital stay
Measured: 90 days
Length of neonatal hospital stay.
Measured: 90 days
Length of maternal hospital stay
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJun 2014
- Primary completionNov 2018 (estimated)
- Study completionDec 2019 (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; Pre-eclampsia, MildStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fetal Medicine Research Center, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373839
- Sponsor's protocol ID
- CEIC 2013/8820
- Acronym
- MAP
- Status last verified
- Feb 2018
- First submitted
- 17 Jan 2014
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peguero A, Herraiz I, Perales A, Melchor JC, Melchor I, Marcos B, Villalain C, Martinez-Portilla R, Mazarico E, Meler E, Hernandez S, Matas I, Del Rio M, Galindo A, Figueras F. Placental growth factor testing in the management of late preterm preeclampsia without severe features: a multicenter, randomized, controlled trial. Am J Obstet Gynecol. 2021 Sep;225(3):308.e1-308.e14. doi: 10.1016/j.ajog.2021.03.044. Epub 2021 Apr 3.
PubMed 33823150
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Placental Growth Factor (PlGF) in the Management of Non-Severe Preeclampsia, a Randomized Study
- ClinicalTrials.gov ID
- NCT02373839
- Acronym / sponsor ID
- MAP / CEIC 2013/8820
- Conditions
- Pregnancy; Pre-eclampsia, Mild
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fetal Medicine Research Center, SpainUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 27 Feb 2015 (estimated)
- 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.
Preeclampsia is an important disease that develops during pregnancy and it is one of the main contributors to maternal and fetal complications.
The only known definitive treatment is delivery. Although delivery is always appropriate for the mother, it might not be the best for a very premature neonate.
In cases of non-severe preeclampsia there no benefit delaying delivery beyond 37 weeks. It is also well established that before 34 weeks an expectant management confers perinatal benefit with minimum amount of additional maternal risk. There is then an area of uncertainty between 37 and 37 weeks. This is why in this period it is a clinical need to select high risk patients of complications that will benefit from labor induction, and differentiate them from low risk patients that can be manage expectantly until 37 weeks.
Placental growth factor (PlGF) is an angiogenic factor that is lower in pregnant women with preeclampsia and current evidence shows that it as a predictor of adverse pregnancy outcome and requirement of delivery.
Circulating levels of PIGF at 34 weeks could help to identify those women that may benefit from labor induction and those where delivery can be delayed until 37 weeks with low risk for maternal complications.
Detailed description
BACKGROUND
The current definition of pre-eclampsia is a new onset hypertension (>140/90mmHg) and proteinuria (>0'3g per 24 hours) after 20 weeks of gestation. Pre-eclampsia affects 3% to 8% of all pregnancies and it is a leading cause of maternal and neonatal morbidity and mortality.
It has been subclassified by clinical severity in severe and non-severe and by gestational age at the diagnosis in early and late onset pre-eclampsia (>34 weeks of gestation).
Pre-eclampsia is associated with abnormal placentation and uterine angiogenesis. Pregnant women with preeclampsia show lower circulating levels of placental growth factor (PlGF), a proangiogenic factor related to placental angiogenesis, compared with healthy pregnant women. Moreover evidence has been found regarding the role of PlGF as a predictor of adverse pregnancy outcome and requirement of delivery.
The only definitive treatment of the disease is delivery. In patients with non-severe preeclampsia between 34 and 37 weeks there is no consensus regarding the ideal time of delivery.
AIM: The aim of this study is to assess whether circulating levels of PIGF at 34 weeks could help to identify those women that may benefit from labor induction and those where delivery can be delayed until 37 weeks with low risk for maternal complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PlGF measurement | Other | Other: Measurement of PlGFDetermination of PlGF levels. If lower than 100 pg/mL labour will be inducted at the moment of diagnosis. Otherwise standard monitoring will be done with labour induction at 37 weeks. |
| Controls | No intervention | –induction of labour at 37 weeks of gestation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > or = 18 years
- pregnant women with non-severe preeclampsia
- gestational age between 34 and 36.5 weeks
Key exclusion criteria (1 listed)
- No exclusion criteria are defined (intention-to-treat analysis)
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 |
|---|---|---|
| Measurement of PlGFIf lower than 100 pg/mL labour will be inducted at the moment of diagnosis. Otherwise standard monitoring will be done with labour induction at 37 weeks | Other | PlGF measurement |
Primary outcome
composite of maternal complications
Time frame: gestational age between 34 and 36.5 weeks
Maternal complications as HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet count), pulmonary oedema, severe hypertension, eclampsia, thromboembolic disease...
Composite of neonatal morbidity
Time frame: 2 weeks
Verma A J Epidemiol Communitary Health 2005 Score
4 secondary outcomes
maternal risk at induction
Time frame: 1 day
Average length of maternal hospital stay
Time frame: 90 days
Length of neonatal hospital stay.
Time frame: 90 days
Length of maternal hospital stay
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Derived from this study: PubMed 33823150Peguero A, Herraiz I, Perales A, Melchor JC, Melchor I, Marcos B, Villalain C, Martinez-Portilla R, Mazarico E, Meler E, Hernandez S, Matas I, Del Rio M, Galindo A, Figueras F. Placental growth factor testing in the management of late preterm preeclampsia without severe features: a multicenter, randomized, controlled trial. Am J Obstet Gynecol. 2021 Sep;225(3):308.e1-308.e14. doi: 10.1016/j.ajog.2021.03.044. Epub 2021 Apr 3.
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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.
Estefania Callado contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of PlGF in people with Pregnancy; Pre-eclampsia, Mild, run by Fetal Medicine Research Center, Spain at 1 site in Spain.
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 3 inclusion and 1 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 12 Feb 2018. 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 Spain. 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 Estefania Callado (ecallado@clinic.ub.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite of maternal complications (time frame: gestational age between 34 and 36.5 weeks). The study lists 2 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 NCT02373839, 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 12 Feb 2018.