Placental growth factor testing in the management of late preterm preeclampsia without severe features: a multicenter, randomized, controlled trial.


Journal

American journal of obstetrics and gynecology
ISSN: 1097-6868
Titre abrégé: Am J Obstet Gynecol
Pays: United States
ID NLM: 0370476

Informations de publication

Date de publication:
09 2021
Historique:
received: 23 11 2020
revised: 14 03 2021
accepted: 25 03 2021
pubmed: 7 4 2021
medline: 28 9 2021
entrez: 6 4 2021
Statut: ppublish

Résumé

In women with late preterm preeclampsia, the optimal time for delivery remains a controversial topic, because of the fine balance between the maternal benefits from early delivery and the risks for prematurity. It remains challenging to define prognostic markers to identify women at highest risk for complications, in which case a selective, planned delivery may reduce the adverse maternal and perinatal outcomes. This trial aimed to determine whether using an algorithm based on the maternal levels of placental growth factor in women with late preterm preeclampsia to evaluate the best time for delivery reduced the progression to preeclampsia with severe features without increasing the adverse perinatal outcomes. This parallel-group, open-label, multicenter, randomized controlled trial was conducted at 7 maternity units across Spain. We compared selective planned deliveries based on maternal levels of placental growth factor at admission (revealed group) and expectant management under usual care (concealed group) with individual randomization in singleton pregnancies with late preterm preeclampsia from 34 to 36+6 weeks' gestation. The coprimary maternal outcome was the progression to preeclampsia with severe features. The coprimary neonatal outcome was morbidity at infant hospital discharge with a noninferiority hypothesis (noninferiority margin of 10% difference in incidence). Analyses were conducted according to intention-to-treat. Between January 1, 2016, and December 31, 2019, 178 women were recruited. Of those women, 88 were assigned to the revealed group and 90 were assigned to the concealed group. The data analysis was performed before the completion of the required sample size. The proportion of women with progression to preeclampsia with severe features was significantly lower in the revealed group than in the concealed group (adjusted relative risk, 0.5; 95% confidence interval, 0.33-0.76; P=.001). The proportion of infants with neonatal morbidity was not significantly different between groups (adjusted relative risk, 0.77; 95% confidence interval, 0.39-1.53; P=.45). There is evidence to suggest that the use of an algorithm based on placental growth factor levels in women with late preterm preeclampsia leads to a lower rate of progression to preeclampsia with severe features and reduces maternal complications without worsening the neonatal outcomes. This trade-off should be discussed with women with late preterm preeclampsia to allow shared decision making about the timing of delivery.

Sections du résumé

BACKGROUND
In women with late preterm preeclampsia, the optimal time for delivery remains a controversial topic, because of the fine balance between the maternal benefits from early delivery and the risks for prematurity. It remains challenging to define prognostic markers to identify women at highest risk for complications, in which case a selective, planned delivery may reduce the adverse maternal and perinatal outcomes.
OBJECTIVE
This trial aimed to determine whether using an algorithm based on the maternal levels of placental growth factor in women with late preterm preeclampsia to evaluate the best time for delivery reduced the progression to preeclampsia with severe features without increasing the adverse perinatal outcomes.
STUDY DESIGN
This parallel-group, open-label, multicenter, randomized controlled trial was conducted at 7 maternity units across Spain. We compared selective planned deliveries based on maternal levels of placental growth factor at admission (revealed group) and expectant management under usual care (concealed group) with individual randomization in singleton pregnancies with late preterm preeclampsia from 34 to 36+6 weeks' gestation. The coprimary maternal outcome was the progression to preeclampsia with severe features. The coprimary neonatal outcome was morbidity at infant hospital discharge with a noninferiority hypothesis (noninferiority margin of 10% difference in incidence). Analyses were conducted according to intention-to-treat.
RESULTS
Between January 1, 2016, and December 31, 2019, 178 women were recruited. Of those women, 88 were assigned to the revealed group and 90 were assigned to the concealed group. The data analysis was performed before the completion of the required sample size. The proportion of women with progression to preeclampsia with severe features was significantly lower in the revealed group than in the concealed group (adjusted relative risk, 0.5; 95% confidence interval, 0.33-0.76; P=.001). The proportion of infants with neonatal morbidity was not significantly different between groups (adjusted relative risk, 0.77; 95% confidence interval, 0.39-1.53; P=.45).
CONCLUSION
There is evidence to suggest that the use of an algorithm based on placental growth factor levels in women with late preterm preeclampsia leads to a lower rate of progression to preeclampsia with severe features and reduces maternal complications without worsening the neonatal outcomes. This trade-off should be discussed with women with late preterm preeclampsia to allow shared decision making about the timing of delivery.

Identifiants

pubmed: 33823150
pii: S0002-9378(21)00224-6
doi: 10.1016/j.ajog.2021.03.044
pii:
doi:

Substances chimiques

Biomarkers 0
Placenta Growth Factor 144589-93-5

Banques de données

ClinicalTrials.gov
['NCT02373839']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

308.e1-308.e14

Informations de copyright

Copyright © 2021 Elsevier Inc. All rights reserved.

Auteurs

Anna Peguero (A)

BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), Institut Clínic de Ginecologia, Obstetrícia i Neonatologia Fetal i+D Fetal Medicine Research Center, Barcelona, Spain.

Ignacio Herraiz (I)

Fetal Medicine Unit-Red de Salud Materno Infantil y del Desarrollo (SAMID), Department of Obstetrics and Gynecology, Hospital Universitario 12 de Octubre. Instituto de Investigación Hospital 12 de Octubre (imas12). Universidad Complutense de Madrid, Madrid, Spain.

Alfredo Perales (A)

Department of Obstetrics and Gynecology, Hospital Universitario La Fe, Valencia, Spain.

Juan Carlos Melchor (JC)

Obstetrics and Gynecology Service, BioCruces Health Research Institute, Hospital Universitario Cruces (Basque Country University), Biscay, Spain.

Iñigo Melchor (I)

Obstetrics and Gynecology Service, BioCruces Health Research Institute, Hospital Universitario Cruces (Basque Country University), Biscay, Spain.

Beatriz Marcos (B)

Department of Obstetrics and Gynecology, Hospital Universitario La Fe, Valencia, Spain.

Cecilia Villalain (C)

Fetal Medicine Unit-Red de Salud Materno Infantil y del Desarrollo (SAMID), Department of Obstetrics and Gynecology, Hospital Universitario 12 de Octubre. Instituto de Investigación Hospital 12 de Octubre (imas12). Universidad Complutense de Madrid, Madrid, Spain.

Raigam Martinez-Portilla (R)

BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), Institut Clínic de Ginecologia, Obstetrícia i Neonatologia Fetal i+D Fetal Medicine Research Center, Barcelona, Spain.

Edurne Mazarico (E)

BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), Institut Clínic de Ginecologia, Obstetrícia i Neonatologia Fetal i+D Fetal Medicine Research Center, Barcelona, Spain.

Eva Meler (E)

BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), Institut Clínic de Ginecologia, Obstetrícia i Neonatologia Fetal i+D Fetal Medicine Research Center, Barcelona, Spain; Department of Obstetrics, Gynecology, and Reproductive Medicine, Dexeus University Hospital, Universitat Autònoma de Barcelona, Barcelona, Spain.

Sandra Hernandez (S)

BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), Institut Clínic de Ginecologia, Obstetrícia i Neonatologia Fetal i+D Fetal Medicine Research Center, Barcelona, Spain.

Isabel Matas (I)

BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), Institut Clínic de Ginecologia, Obstetrícia i Neonatologia Fetal i+D Fetal Medicine Research Center, Barcelona, Spain.

Maria Del Rio (M)

Obstetrics and Gynecology, Hospital de la Creu Roja, L'Hospitalet de Llobregat, Barcelona, Spain.

Alberto Galindo (A)

Fetal Medicine Unit-Red de Salud Materno Infantil y del Desarrollo (SAMID), Department of Obstetrics and Gynecology, Hospital Universitario 12 de Octubre. Instituto de Investigación Hospital 12 de Octubre (imas12). Universidad Complutense de Madrid, Madrid, Spain.

Francesc Figueras (F)

BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), Institut Clínic de Ginecologia, Obstetrícia i Neonatologia Fetal i+D Fetal Medicine Research Center, Barcelona, Spain. Electronic address: ffiguera@clinic.cat.

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