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RECAB-ASA; Treatment of Recurrent Abortion With Aspirin (RECAB-ASA)

Primary Purpose

Abortion, Habitual

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Aspirin

Placebo

About this trial

This is an interventional treatment trial for Abortion, Habitual focused on measuring recurrent pregnancy loss, Habitual abortion

Eligibility Criteria

undefined - 39 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Low dose aspirin

Placebo

Arm Description

75 mg aspirin orally daily from gestational week 7-35

Placebo pill orally daily from gestational week 7-35

Outcomes

Primary Outcome Measures

Live birth

Secondary Outcome Measures

Spontaneous abortion

Vaginal bleeding

Premature delivery

intrauterine growth retardation, measured by ultrasound as percentage deviation

Preeclampsia

Pregnancy induced hypertension

Placenta praevia

Perinatal mortality

Perinatal morbidity

Full Information

NCT ID

NCT02823743

First Posted

June 28, 2016

Last Updated

July 5, 2016

Sponsor

Göteborg University

Collaborators

Vastra Gotaland Region

1. Study Identification

Unique Protocol Identification Number

NCT02823743

Brief Title

RECAB-ASA; Treatment of Recurrent Abortion With Aspirin

Acronym

RECAB-ASA

Official Title

Treatment of Recurrent Abortion With Low Dose Aspirin - a Randomized Placebo Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Göteborg University

Collaborators

Vastra Gotaland Region

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abortion, Habitual

Keywords

recurrent pregnancy loss, Habitual abortion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dose aspirin

Arm Type

Experimental

Arm Description

75 mg aspirin orally daily from gestational week 7-35

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo pill orally daily from gestational week 7-35

Intervention Type

Drug

Intervention Name(s)

Aspirin

Other Intervention Name(s)

ASA

Intervention Description

Daily medication

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Daily intake

Primary Outcome Measure Information:

Title

Live birth

Time Frame

delivery

Secondary Outcome Measure Information:

Title

Spontaneous abortion

Time Frame

up to 22 weeks

Title

Vaginal bleeding

Time Frame

up to 42 weeks

Title

Premature delivery

Time Frame

At delivery

Title

intrauterine growth retardation, measured by ultrasound as percentage deviation

Time Frame

up to 42 weeks

Title

Preeclampsia

Time Frame

up to 42 weeks

Title

Pregnancy induced hypertension

Time Frame

up to 42 weeks

Title

Placenta praevia

Time Frame

up to 42 weeks

Title

Perinatal mortality

Time Frame

Third trimester and 28 days after delivery

Title

Perinatal morbidity

Time Frame

28 days after delivery

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Annika Strandell, Ass.prof.

Organizational Affiliation

Göteborg University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

RECAB-ASA; Treatment of Recurrent Abortion With Aspirin

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