NCT02823743

Brief Summary

The aim of this study is to examine whether treatment with 75 mg aspirin daily compared with placebo could reduce the risk for a new miscarriage. The treatment starts when the pregnancy is detected on transvaginal ultrasound (around gestational week 6+) and continues to week 35/36. The study is a single center, randomized, placebo-controlled, double blind and stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are enrolled, 200 in each arm aspirin / placebo.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2008

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2016

Completed
Last Updated

July 6, 2016

Status Verified

July 1, 2016

Enrollment Period

8.1 years

First QC Date

June 28, 2016

Last Update Submit

July 5, 2016

Conditions

Abortion, Habitual

Keywords

recurrent pregnancy loss, Habitual abortion

Outcome Measures

Primary Outcomes (1)

  • Live birth

    delivery

Secondary Outcomes (9)

  • Spontaneous abortion

    up to 22 weeks

  • Vaginal bleeding

    up to 42 weeks

  • Premature delivery

    At delivery

  • intrauterine growth retardation, measured by ultrasound as percentage deviation

    up to 42 weeks

  • Preeclampsia

    up to 42 weeks

  • +4 more secondary outcomes

Study Arms (2)

Low dose aspirin

EXPERIMENTAL

75 mg aspirin orally daily from gestational week 7-35

Drug: Aspirin

Placebo

PLACEBO COMPARATOR

Placebo pill orally daily from gestational week 7-35

Drug: Placebo

Interventions

AspirinDRUG

Daily medication

Also known as: ASA
Low dose aspirin
PlaceboDRUG

Daily intake

Placebo

Eligibility Criteria

AgeUp to 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • recurrent abortion (≤ 3 consecutive abortions in first trimester)
  • unknown etiology after work-up
  • willingness to be randomized

You may not qualify if:

  • previous participation in the study
  • known cause of recurrent abortion, requiring specific management
  • age ≥ 40
  • BMI above 35
  • IVF pregnancy if the reason for IVF was recurrent spontaneous abortion
  • ongoing treatment with aspirin for other reason
  • Sjoegren syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abortion, Habitual

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Abortion, SpontaneousPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Annika Strandell, Ass.prof.

    Göteborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 28, 2016

First Posted

July 6, 2016

Study Start

March 1, 2008

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

July 6, 2016

Record last verified: 2016-07