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NCT Number: NCT06111079

Aspirin Discontinuation in High-Risk Pregnant Women of Preeclampsia

Low-dose aspirin (LDA) is considered to be the most effective agent to prevent preeclampsia (PE). At present, there is little exploration about the timing of aspirin discontinuation. Most international guidelines default until 36 weeks of gestation or delivery. China Guideline (2020) recommended that aspirin should be preventively used until 26-28 weeks of gestation, but there was little direct evidence. According to the two-stage theory, placental dysplasia before 28 weeks of gestation is the key to developing PE, the significance of aspirin use after 28 weeks of gestation is debatable. If aspirin discontinuation at 28 weeks of gestation is proven to be feasible for preventing preterm PE, it will not only reduce the risk of Perinatal Haemorrhage but also save medical expenses.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Perinatal Haemorrhage Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

About this study

This study aimed to optimize the strategy of aspirin to prevent preeclampsia, by exploring whether aspirin discontinuation at 28 weeks of gestation to prevent preterm PE is not inferior to 36 weeks of gestation. We will include pregnant women with normal NT scan who meet at least one high-risk factor or at least two medium-risk factors. During 12-16 weeks of gestation, the mean arterial pressure (MAP) and placental growth factor (PlGF) are measured, then initiating aspirin 100mg qn. At 24-27+6 weeks of gestation, the patients were 1:1 randomly divided into two groups, sFlt-1 and PlGF were detected at the same time. The experimental group discontinue aspirin at 28 weeks of gestation, and the control group receive aspirin until 36 weeks of gestation. The incidence of preterm PE in the two groups was compared by non-inferiority test, and the non-inferiority threshold was 2%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At <16 weeks of gestation, normal NT scan
  • At least 1 high risk factor or at least 2 moderate risk factors
  • Intend to receive prenatal examination and deliver in this institution
  • Signed a written informed consent for participation in the study

Exclusion criteria

  • Aspirin initiated after 16 week
  • Intolerant or allergic to aspirin
  • Aspirin adherence was <80%
  • Miscarriage or termination of pregnancy before randomization
  • drop out (do not return to the hospital for delivery).
  • Lost to follow-up

Treatment and study plan

aspirin discontinuation

Drug

Initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, discontinuing aspirin at 28 weeks of gestation according to randomization at 24-27+6 weeks of gestation.

Other names: initiation of aspirin in early pregnancy

aspirin continuation

Drug

Initiation of aspirin 100mg qn from 12 to 16 weeks of gestation, continuing aspirin until 36 weeks of gestation according to randomization at 24-27+6 weeks of gestation.

Other names: initiation of aspirin in early pregnancy

Primary outcomes

  1. Incidence of preterm preeclampsia

    Time frame: Within one week after delivery

    delivery with preeclampsia before 37 weeks of gestation

Secondary outcomes

  1. Incidence of early-onset preeclampsia

    Time frame: Within one week after delivery

    delivery with preeclampsia before 34 weeks of gestation

  2. Incidence of term preeclampsia

    Time frame: Within one week after delivery

    delivery with preeclampsia after 37 weeks of gestation

  3. Incidence of gestational hypertension

    Time frame: Within one week after delivery

    new onset of high blood pressure after 20 weeks of gestation (systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg)

  4. Incidence of small for gestational age

    Time frame: Within one week after delivery

    birth weight below the 10th percentile

Study contacts

Contact information is provided by the study sponsor or research team.

Fang He, M.D

CONTACT

[email protected]

+86 13724831279

Qingwen Nie, Master

CONTACT

[email protected]

+86 15622149953

Sponsors and collaborators

Lead sponsor

FANG HE

Other

Registry information

Official study title

Aspirin Discontinuation at 28 or 36 Weeks' Gestation in High-Risk Pregnant Women of Preeclampsia A Randomized Clinical Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 1, 2023
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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