The Investigation of the Prediction Model and Prevention Strategy of Serious Pregnancy Complications in Hypertensive Disorders of Pregnancy Based on the Chinese Population

NCT05089175 | Unknown DMC

• 1 other identifier: ChiCTR2100048266
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 1

Brief Summary

1\. Evaluation of the efficacy of aspirin in preventing preeclampsia and its serious complications during pregnancy and postpartum. 2. To establish a risk prediction model for severe pregnancy complications in pregnant women with hypertensive disorders of pregnancy.

Conditions

Hypertensive Disorder of Pregnancy; Pregnancy Complications

Keywords

Risk prediction; Preeclampsia Prevention; Hypertensive disorders of pregnancy

Outcome Measures

Primary Outcomes (1)

• Number diagnosed with pre-eclampsia

  According to the ISSHP, PE is defined as systolic blood pressure at ≥140 mm Hg and/or diastolic blood pressure at ≥90 mm Hg on at least two occasions measured 4 hours apart in previously normotensive women and is accompanied by one or more of the following new onset conditions at or after 20 weeks of gestation: 1. Proteinuria (i.e. ≥30 mg/mol protein:creatinine ratio; ≥300 mg/24 hour; or ≥2 + dipstick); 2. Evidence of other maternal organ dysfunction, including: acute kidney injury (creatinine ≥90 μmol/L; 1 mg/dL); liver involvement (elevated transaminases, e.g. alanine aminotransferase or aspartate aminotransferase \>40 IU/L) with or without right upper quadrant or epigastric abdominal pain; neurological complications ; or hematological complications ; or 3. Uteroplacental dysfunction .

  After 20th week of gestation

Secondary Outcomes (1)

• Number of women with adverse outcomes

  After 20th week of gestation

Study Arms (2)

Women at high risk for preeclampsia

Using FIGO recommended preeclampsia screening model for the first-trimester which combined maternal risk factors, mean arterial pressure, placental growth factor, uterine artery pulsatility index to evaluate pregnant's risk for preeclampsia. Risk value≥1/100 is defined as screened high risk.

Drug: Low-dose aspirin

Women at low risk for preeclampsia

Using FIGO recommended preeclampsia screening model for the first-trimester which combined maternal risk factors, mean arterial pressure, placental growth factor, uterine artery pulsatility index to evaluate pregnant's risk for preeclampsia. Risk value\<1/100 is defined as screened low risk.

Interventions

Low-dose aspirin DRUG

FIGO adopts and supports that in high-risk women, defined by the first-trimester combined test, aspirin \~150 mg/night should be commenced at 11-14+6 weeks of gestation until either 36 weeks of gestation, when delivery occurs, or when pre-eclampsia is diagnosed.

Women at high risk for preeclampsia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Pregnant women

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (4)

• Poon LC, Shennan A, Hyett JA, Kapur A, Hadar E, Divakar H, McAuliffe F, da Silva Costa F, von Dadelszen P, McIntyre HD, Kihara AB, Di Renzo GC, Romero R, D'Alton M, Berghella V, Nicolaides KH, Hod M. The International Federation of Gynecology and Obstetrics (FIGO) initiative on pre-eclampsia: A pragmatic guide for first-trimester screening and prevention. Int J Gynaecol Obstet. 2019 May;145 Suppl 1(Suppl 1):1-33. doi: 10.1002/ijgo.12802.

  PMID: 31111484 BACKGROUND

• Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.

  PMID: 28657417 BACKGROUND

• von Dadelszen P, Payne B, Li J, Ansermino JM, Broughton Pipkin F, Cote AM, Douglas MJ, Gruslin A, Hutcheon JA, Joseph KS, Kyle PM, Lee T, Loughna P, Menzies JM, Merialdi M, Millman AL, Moore MP, Moutquin JM, Ouellet AB, Smith GN, Walker JJ, Walley KR, Walters BN, Widmer M, Lee SK, Russell JA, Magee LA; PIERS Study Group. Prediction of adverse maternal outcomes in pre-eclampsia: development and validation of the fullPIERS model. Lancet. 2011 Jan 15;377(9761):219-27. doi: 10.1016/S0140-6736(10)61351-7. Epub 2010 Dec 23.

  PMID: 21185591 BACKGROUND

• Navaratnam K, Alfirevic A, Jorgensen A, Alfirevic Z. Aspirin non-responsiveness in pregnant women at high-risk of pre-eclampsia. Eur J Obstet Gynecol Reprod Biol. 2018 Feb;221:144-150. doi: 10.1016/j.ejogrb.2017.12.052. Epub 2018 Jan 1.

  PMID: 29304392 BACKGROUND

MeSH Terms

Conditions

Toxemia; Pregnancy Complications

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Infections; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Baohua Li, Phd

  Chief of obstetrics and gynecology

  STUDY DIRECTOR

Central Study Contacts

Baohua Li, Phd

CONTACT

13777477364; lbh19787@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 29 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 22, 2021
• Study Start: November 30, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: December 2, 2021

Record last verified: 2021-12

Locations

CN (1)