Condition category
Pregnancy and Childbirth
Date applied
29/06/2016
Date assigned
19/07/2016
Last edited
18/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Plain English summary under review

Trial website

http://www2.cch.org.tw/IRB/

Contact information

Type

Scientific

Primary contact

Dr Ming Chen

ORCID ID

http://orcid.org/0000-0001-5076-2917

Contact details

Changhua Christian Hospital
135 Nanhsiao Street
Changhua
500
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Changhua Christian Hospital IRB No.: 151209

Study information

Scientific title

The role of low-molecular-weight-heparin in women with recurrent pregnancy loss and protein S deficiency

Acronym

Study hypothesis

The aim of this study is to investigate the therapeutic effect of low molecular weight heparin on women with recurrent pregnancy loss and documented protein S deficiency.

Ethics approval

Changhua Christian Hospital IRB, 16/02/2016, ref: 151209

Study design

Part 1:
Retrospective cohort medical record review

Part 2:
Interventional non-randomised study

Primary study design

Other

Secondary study design

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Recurrent miscarriage

Intervention

Part 1:
Women who had recurrent pregnancy loss (RPL) who have been prescribed heparin between 2011 and 2015 as part of their standard medical care have their medical notes reviewed. Lab tests, including genetic (karyotyping), hematological (thrombophilic factors including protein S, protein C, and anti-thrombin III), immunological (lupus anticoagulant and anti-cardiolipin antibodies IgG, IgM), as well as the past history or lab and physical exam test results to exclude coexisting medical conditions such as diabetes mellitus and chronic essential hypertension are reviewed. Women found to have a protein S deficiency have their gestational records reviewed in addition to determine gestational age of delivery, the mode of delivery, the birth body weight, and obstetric complication rate.

Part 2:
All participants receive low molecular weight heparin (enoxaparin) in a dose of 1mg/Kg every 12 hours from the time of enrollment to the day (at least 24 hours) before delivery, in addition to normal antenatal examinations and treatment. Participants medical records are reviewed following delivery to establish live birth rate and obstetric complication rate.

Intervention type

Phase

Drug names

Primary outcome measures

Live birth rate is measured using the outcome of pregnancy at either abortion or live-births at the time of delivery collected from medical records.

Secondary outcome measures

Obstetric complication rate is measured using specific parameters such as the birth body weight (if it is low birth weight for gestational age, or appropriate for gestational age), the gestational age when delivery (if less than 28 weeks, between 28 and 36 weeks of gestation, or term pregnancy meaning delivered later than 36 complete weeks of gestation) at delivery collected from medical records.

Overall trial start date

01/01/2011

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Part 1:
1. Women of child-bearing age
2. Recurrent pregnancy loss
3. Treated with heparin as part of standard care between 2011 and 2015

Part 2:
1. Women of child-bearing age
2. Recurrent pregnancy loss
3. Protein S deficiency (both the free antigen and function of protein S were reduced)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

1. Allergic to heparin or other Low Molecular Weight Heparins
2. Problem with bruising or bleeding too easily
3. History of heparin-induced thrombocytopenia
4. Stroke
5. Recently had an operation on brain
6. Renal dysfunction

Recruitment start date

16/02/2016

Recruitment end date

15/02/2017

Locations

Countries of recruitment

Taiwan

Trial participating centre

Changhua Christian Hospital
135 Nanhsiao Street, Changhua, 500 Taiwan
Changhua
500
Taiwan

Sponsor information

Organisation

Changhua Christian Hospital

Sponsor details

135 Nanhsiao Street
Changhua
500
Taiwan

Sponsor type

Hospital/treatment centre

Website

http://www.cch.org.tw/

Funders

Funder type

Hospital/treatment centre

Funder name

Changhua Christian Hospital

Alternative name(s)

CCH

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Taiwan

Results and Publications

Publication and dissemination plan

Planned publication of results in a peer reviewed journal.

Intention to publish date

31/12/2016

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes