Aspirin Versus Metformin in Pregnancies at High Risk of Preterm Preeclampsia: a 3-arm Randomized Controlled Trial

Last updated: November 5, 2023
Sponsor: Chinese University of Hong Kong
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pregnancy Complications

Preeclampsia

Treatment

Aspirin 75mg

Aspirin 150 mg

150 mg acetylsalicylic acid

Clinical Study ID

NCT05580523
MOST-AVERT
  • Ages > 18
  • Female

Study Summary

This is a prospective, multicenter, randomized controlled, double-blind trial of three treatment arms: (1) aspirin 75 mg/day vs. (2) aspirin 150 mg/day vs. (3) aspirin 75 mg/day with metformin 1.5 g/day from the first trimester to compare the incidence of preterm preeclampsia with delivery at <37 week's gestation between the treatment arms, in order to determine the optimal therapeutic intervention for the prevention of preterm preeclampsia among Chinese women at high-risk of preeclampsia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Singleton pregnancies
  • Live fetus at 11-13 weeks' gestation
  • High-risk for preterm preeclampsia at 11-13 weeks by the algorithm combining maternalcharacteristics, medical and obstetric history, MAP and serum PlGF
  • Informed and written consent

Exclusion

Exclusion Criteria:

  • Age <18 years old
  • Multiple pregnancies
  • Treatment with low-dose aspirin and metformin at the time of screening
  • Pregnancies complicated by major fetal abnormality identified during the firsttrimester
  • Women with learning difficulties, or serious mental illness
  • Bleeding disorders such as Von Willebrand's disease
  • Active peptic ulceration or gastrointestinal bleeding
  • Hypersensitivity to aspirin, metformin hydrochloride and other biguanides
  • Treatment with long term nonsteroidal anti-inflammatory medication
  • Hyperemesis gravidarum
  • Renal, liver or heart failure
  • A serious medical condition
  • Concurrent participation in another drug trial or at any time within the previous 28days
  • Any other reason the clinical investigators think will prevent the potentialparticipant from complying with the trial protocol.

Study Design

Total Participants: 3000
Treatment Group(s): 8
Primary Treatment: Aspirin 75mg
Phase:
Study Start date:
July 03, 2023
Estimated Completion Date:
November 30, 2025

Study Description

All women with singleton pregnancies who are attending for their routine hospital visit at 11-13 weeks' gestation will be invited to undergo screening for preeclampsia. We use a Bayes theorem-based method that combines maternal characteristics, medical and obstetric history together with mean arterial pressure (MAP) and serum placental growth factor (PlGF) level. Women who are deemed high-risk following first trimester combined screening (cutoff corresponding to a screen positive rate of 10%, e.g ≥1 in 80) will be invited to participate in the 3-arm randomized controlled trial.

Connect with a study center

  • Peking University First Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Guangzhou Women and Children's Medical Center

    Guangzhou, Guangdong
    China

    Site Not Available

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Shanghai First Maternity and Infant Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • West China Second University Hospital, Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

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