NCT02174328

Brief Summary

The main objective of this trial is to study the occurrence of preeclampsia in recipients of donated oocytes receiving aspirin at an early stage during pregnancy and to compare the results with those obtained in patients receiving placebo.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2014

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

May 21, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2018

Completed
Last Updated

April 26, 2019

Status Verified

April 1, 2019

Enrollment Period

3.9 years

First QC Date

September 11, 2013

Last Update Submit

April 25, 2019

Conditions

Pre-Eclampsia

Keywords

See incidence of Pre-Eclampsia in acetylsalicylic acid groupSee incidence of Pre-Eclampsia in placebo group

Outcome Measures

Primary Outcomes (1)

  • Occurrence of preeclampsia.

    The main objective is to study the occurrence of preeclampsia in recipients of donated oocytes receiving aspirin at an early stage during pregnancy, and to compare the results with those obtained in patients receiving placebo.

    Up to 42 weeks

Secondary Outcomes (1)

  • Other complications

    Up to 42 weeks

Other Outcomes (1)

  • Inflammatory mediators involved in angiogenesis.

    Up to 42 weeks

Study Arms (2)

acetylsalicylic acid

EXPERIMENTAL

This group will receive 1 tablet of acetylsalicylic acid (100 mg) orally daily from 5-10 weeks gestation until the end of gestation, about week 36

Drug: Acetylsalicylic acid

Placebo

PLACEBO COMPARATOR

This group will receive 1 tablet of placebo orally each day from 5-10 weeks gestation until the end of gestation, about week 36

Drug: Placebo

Interventions

Acetylsalicylic acidDRUG

Acetylsalicylic acid once a day until 36 week

Also known as: ADIRO 100
acetylsalicylic acid
PlaceboDRUG

Placebo once a day until 36 week

Also known as: Not active drug
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients over 18 years.
  • Recipients of donated oocytes.
  • Pregnant women.
  • Single or twin gestations.
  • Patients who accept the conditions of the study by signing the appropriate informed consent.

You may not qualify if:

  • Known allergy to acetylsalicylic acid .
  • Personal history of peptic ulcer.
  • Triplets.
  • Use of prostaglandin inhibitors within 10 days prior to baseline.
  • Personal history of chronic kidney, thyroid, liver or heart disease.
  • Psychiatric or cognitive pathology that prevents understanding of the conditions of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Obstetrics Unit of La Fe University and Politechnic Hospital

Valencia, 46026, Spain

Location

Related Publications (25)

  • Ebrashy A, Ibrahim M, Marzook A, Yousef D. Usefulness of aspirin therapy in high-risk pregnant women with abnormal uterine artery Doppler ultrasound at 14-16 weeks pregnancy: randomized controlled clinical trial. Croat Med J. 2005 Oct;46(5):826-31.

    PMID: 16158479BACKGROUND

  • ACOG Committee on Practice Bulletins--Obstetrics. ACOG practice bulletin. Diagnosis and management of preeclampsia and eclampsia. Number 33, January 2002. Obstet Gynecol. 2002 Jan;99(1):159-67. doi: 10.1016/s0029-7844(01)01747-1.

    PMID: 16175681BACKGROUND

  • Akolekar R, de Cruz J, Foidart JM, Munaut C, Nicolaides KH. Maternal plasma soluble fms-like tyrosine kinase-1 and free vascular endothelial growth factor at 11 to 13 weeks of gestation in preeclampsia. Prenat Diagn. 2010 Mar;30(3):191-7. doi: 10.1002/pd.2433.

    PMID: 20101671BACKGROUND

  • Akolekar R, Syngelaki A, Sarquis R, Zvanca M, Nicolaides KH. Prediction of early, intermediate and late pre-eclampsia from maternal factors, biophysical and biochemical markers at 11-13 weeks. Prenat Diagn. 2011 Jan;31(1):66-74. doi: 10.1002/pd.2660.

    PMID: 21210481BACKGROUND

  • Akolekar R, Zaragoza E, Poon LC, Pepes S, Nicolaides KH. Maternal serum placental growth factor at 11 + 0 to 13 + 6 weeks of gestation in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Nov;32(6):732-9. doi: 10.1002/uog.6244.

    PMID: 18956425BACKGROUND

  • Audibert F, Boucoiran I, An N, Aleksandrov N, Delvin E, Bujold E, Rey E. Screening for preeclampsia using first-trimester serum markers and uterine artery Doppler in nulliparous women. Am J Obstet Gynecol. 2010 Oct;203(4):383.e1-8. doi: 10.1016/j.ajog.2010.06.014. Epub 2010 Aug 5.

    PMID: 20691410BACKGROUND

  • Brosens I, Pijnenborg R, Vercruysse L, Romero R. The "Great Obstetrical Syndromes" are associated with disorders of deep placentation. Am J Obstet Gynecol. 2011 Mar;204(3):193-201. doi: 10.1016/j.ajog.2010.08.009. Epub 2010 Nov 20.

    PMID: 21094932BACKGROUND

  • Brown MA, Lindheimer MD, de Swiet M, Van Assche A, Moutquin JM. The classification and diagnosis of the hypertensive disorders of pregnancy: statement from the International Society for the Study of Hypertension in Pregnancy (ISSHP). Hypertens Pregnancy. 2001;20(1):IX-XIV. doi: 10.1081/PRG-100104165. No abstract available.

    PMID: 12044323BACKGROUND

  • Bujold E, Roberge S, Lacasse Y, Bureau M, Audibert F, Marcoux S, Forest JC, Giguere Y. Prevention of preeclampsia and intrauterine growth restriction with aspirin started in early pregnancy: a meta-analysis. Obstet Gynecol. 2010 Aug;116(2 Pt 1):402-414. doi: 10.1097/AOG.0b013e3181e9322a.

    PMID: 20664402BACKGROUND

  • Imperiale TF, Petrulis AS. A meta-analysis of low-dose aspirin for the prevention of pregnancy-induced hypertensive disease. JAMA. 1991 Jul 10;266(2):260-4.

    PMID: 1829118BACKGROUND

  • Keegan DA, Krey LC, Chang HC, Noyes N. Increased risk of pregnancy-induced hypertension in young recipients of donated oocytes. Fertil Steril. 2007 Apr;87(4):776-81. doi: 10.1016/j.fertnstert.2006.08.105. Epub 2007 Jan 29.

    PMID: 17258714BACKGROUND

  • Klatsky PC, Delaney SS, Caughey AB, Tran ND, Schattman GL, Rosenwaks Z. The role of embryonic origin in preeclampsia: a comparison of autologous in vitro fertilization and ovum donor pregnancies. Obstet Gynecol. 2010 Dec;116(6):1387-1392. doi: 10.1097/AOG.0b013e3181fb8e59.

    PMID: 21099607BACKGROUND

  • Levine RJ, Lam C, Qian C, Yu KF, Maynard SE, Sachs BP, Sibai BM, Epstein FH, Romero R, Thadhani R, Karumanchi SA; CPEP Study Group. Soluble endoglin and other circulating antiangiogenic factors in preeclampsia. N Engl J Med. 2006 Sep 7;355(10):992-1005. doi: 10.1056/NEJMoa055352.

    PMID: 16957146BACKGROUND

  • Le Ray C, Scherier S, Anselem O, Marszalek A, Tsatsaris V, Cabrol D, Goffinet F. Association between oocyte donation and maternal and perinatal outcomes in women aged 43 years or older. Hum Reprod. 2012 Mar;27(3):896-901. doi: 10.1093/humrep/der469. Epub 2012 Jan 16.

    PMID: 22252087BACKGROUND

  • Lambers MJ, Groeneveld E, Hoozemans DA, Schats R, Homburg R, Lambalk CB, Hompes PG. Lower incidence of hypertensive complications during pregnancy in patients treated with low-dose aspirin during in vitro fertilization and early pregnancy. Hum Reprod. 2009 Oct;24(10):2447-50. doi: 10.1093/humrep/dep245. Epub 2009 Jul 16.

    PMID: 19608566BACKGROUND

  • Nicolaides KH. A model for a new pyramid of prenatal care based on the 11 to 13 weeks' assessment. Prenat Diagn. 2011 Jan;31(1):3-6. doi: 10.1002/pd.2685. No abstract available.

    PMID: 21210474BACKGROUND

  • Pecks U, Maass N, Neulen J. Oocyte donation: a risk factor for pregnancy-induced hypertension: a meta-analysis and case series. Dtsch Arztebl Int. 2011 Jan;108(3):23-31. doi: 10.3238/arztebl.2011.0023. Epub 2011 Jan 21.

    PMID: 21285999BACKGROUND

  • Poon LC, Akolekar R, Lachmann R, Beta J, Nicolaides KH. Hypertensive disorders in pregnancy: screening by biophysical and biochemical markers at 11-13 weeks. Ultrasound Obstet Gynecol. 2010 Jun;35(6):662-70. doi: 10.1002/uog.7628.

    PMID: 20232288BACKGROUND

  • Ruano R, Fontes RS, Zugaib M. Prevention of preeclampsia with low-dose aspirin -- a systematic review and meta-analysis of the main randomized controlled trials. Clinics (Sao Paulo). 2005 Oct;60(5):407-14. doi: 10.1590/s1807-59322005000500010. Epub 2005 Oct 24.

    PMID: 16254678BACKGROUND

  • Salha O, Sharma V, Dada T, Nugent D, Rutherford AJ, Tomlinson AJ, Philips S, Allgar V, Walker JJ. The influence of donated gametes on the incidence of hypertensive disorders of pregnancy. Hum Reprod. 1999 Sep;14(9):2268-73. doi: 10.1093/humrep/14.9.2268.

    PMID: 10469693BACKGROUND

  • Simhan HN, Caritis SN. Prevention of preterm delivery. N Engl J Med. 2007 Aug 2;357(5):477-87. doi: 10.1056/NEJMra050435. No abstract available.

    PMID: 17671256BACKGROUND

  • Smith GC, Stenhouse EJ, Crossley JA, Aitken DA, Cameron AD, Connor JM. Early pregnancy levels of pregnancy-associated plasma protein a and the risk of intrauterine growth restriction, premature birth, preeclampsia, and stillbirth. J Clin Endocrinol Metab. 2002 Apr;87(4):1762-7. doi: 10.1210/jcem.87.4.8430.

    PMID: 11932314BACKGROUND

  • Soderstrom-Anttila V. Pregnancy and child outcome after oocyte donation. Hum Reprod Update. 2001 Jan-Feb;7(1):28-32. doi: 10.1093/humupd/7.1.28.

    PMID: 11212070BACKGROUND

  • Soderstrom-Anttila V, Tiitinen A, Foudila T, Hovatta O. Obstetric and perinatal outcome after oocyte donation: comparison with in-vitro fertilization pregnancies. Hum Reprod. 1998 Feb;13(2):483-90. doi: 10.1093/humrep/13.2.483.

    PMID: 9557862BACKGROUND

  • Groeneveld E, Lambers MJ, Lambalk CB, Broeze KA, Haapsamo M, de Sutter P, Schoot BC, Schats R, Mol BW, Hompes PG. Preconceptional low-dose aspirin for the prevention of hypertensive pregnancy complications and preterm delivery after IVF: a meta-analysis with individual patient data. Hum Reprod. 2013 Jun;28(6):1480-8. doi: 10.1093/humrep/det022. Epub 2013 Mar 25.

    PMID: 23528915BACKGROUND

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Alfredo Perales, PhD

    Hospital Universitario La Fe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2013

First Posted

June 25, 2014

Study Start

May 21, 2014

Primary Completion

April 20, 2018

Study Completion

April 20, 2018

Last Updated

April 26, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)