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Published on: June 29, 2013
Study protocol for a randomised controlled trial: treatment of early intrauterine growth restriction with low
Edurne Mazarico1,2,3, Anna Peguero4, Marta Camprubí1
1BCNatal - Barcelona Center for Maternal-Fetal and Neonatal Medicine (Hospital Clínic and Hospital Sant Joan de Déu), University of Barcelona, Barcelona, Spain.
Insights
This study investigates if low molecular weight heparin (LMWH) can extend pregnancies in cases of early-onset intrauterine growth restriction (IUGR). The research aims to determine LMWH
Area of Science:
- Obstetrics and Gynecology
- Maternal-Fetal Medicine
- Pharmacology
Background:
- Intrauterine growth restriction (IUGR) affects approximately 3% of pregnancies and is linked to significant perinatal mortality and long-term health issues.
- Early-onset IUGR, often caused by placental insufficiency, necessitates interventions to improve fetal outcomes.
- Low molecular weight heparin (LMWH) shows potential benefits beyond anticoagulation, including improved placental function.
Purpose of the Study:
- To evaluate the effectiveness of low molecular weight heparin (LMWH) in prolonging gestation in pregnancies complicated by early-onset IUGR.
- To assess the impact of LMWH on placental microvessel structure and function in the context of obstetric vascular complications.
Main Methods:
- A multicenter, triple-blind, randomized controlled trial involving singleton pregnancies with early-onset placental IUGR (diagnosed between 20-32 weeks).
- Participants were randomized to receive either subcutaneous bemiparin (a type of LMWH) or a placebo daily until delivery.
- Primary outcomes included gestational age at birth and duration of pregnancy, analyzed using Student's t-tests and Kaplan-Meier survival analysis.
Main Results:
- Pre-results are available; the study is ongoing.
- The primary objective is to compare gestational age and pregnancy prolongation between the bemiparin and placebo groups.
- Secondary analyses will explore factors influencing gestational age at birth, such as gestational age at inclusion and pre-eclampsia.
Conclusions:
- The study is expected to provide crucial data on the efficacy of LMWH in managing early-onset IUGR.
- Findings will inform clinical practice regarding the use of LMWH to improve pregnancy outcomes in cases of placental insufficiency.
- Results will be disseminated via an open-access publication.
Introduction:
The incidence of intrauterine growth restriction (IUGR) is estimated at about 3% of pregnancies, and it is associated with 30% of all perinatal mortality and severe morbidity with adverse neurodevelopmental and cardiovascular health consequences in adult life. Early onset IUGR represents 20%-30% of all cases and is highly associated with severe placental insufficiency. The existing evidence suggests that low molecular weight heparin (LMWH) has effects beyond its antithrombotic action, improving placental microvessel structure and function of pregnant women with vascular obstetric complications by normalising proangiogenic and antiapoptotic protein levels, cytokines and inflammatory factors. The objective of our study is to demonstrate the effectiveness of LMWH in prolonging gestation in pregnancies with early-onset IUGR.
Methods And Analysis:
This is a multicentre, triple-blind, parallel-arm randomised clinical trial. Singleton pregnancies qualifying for early (20-32 weeks at diagnosis) placental IUGR (according to Delphi criteria) will be randomised to subcutaneous treatment with bemiparin 3500 IU/0.2 mL/day or placebo from inclusion at diagnosis to the time of delivery. Analyses will be based on originally assigned groups (intention-to-treat). The primary objective will be analysed by comparing gestational age and prolongation of pregnancy (days) in each group with Student's t-tests for independent samples and by comparing Kaplan-Maier survival curves (from inclusion to delivery, log-rank test). A linear regression model for gestational age at birth will consider the following covariates: gestational age at inclusion (continuous) and pre-eclampsia (binary).
Ethics And Dissemination:
The study will be conducted in accordance with the principles of Good Clinical Practice. This study was approved by the Clinical Research Ethics Committee (CEIC) of Sant Joan de Déu Hospital, on 13 July 2017. The trial is registered in the public registry www.clinicaltrial.gov. according to Science Law 14/2011, and the results will be published in an open access journal.
Trial Registration Number:
NCT03324139; Pre-results.
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