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Clinical Trial Results:
Anticoagulants for Living FoEtuses in women with recurrent miscarriage and inherited thrombophilia : ALIFE 2

Summary
EudraCT number	2015-002357-35
Trial protocol	GB
Global end of trial date	25 Nov 2021

Results information
Results version number	v1(current)
This version publication date	28 Jul 2023
First version publication date	28 Jul 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

SQ147214

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

University Hospitals Coventry and Warwickshire NHS Trust

Sponsor organisation address

University Hospital, Clifford Bridge Road, Coventry, United Kingdom, CV22DX

Public contact

Warwick Clinical Trials Unit, University of Warwick, +44 024 7615 0478, ctuenquiries@warwick.ac.uk

Scientific contact

Warwick Clinical Trials Unit, University of Warwick, +44 024 7615 0478, ctuenquiries@warwick.ac.uk

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

20 Jun 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

09 Nov 2021

Global end of trial reached?

Yes

Global end of trial date

25 Nov 2021

Was the trial ended prematurely?

Main objective of the trial

To evaluate the efficacy of low molecular weight heparin (LMWH) in women with inherited thrombophilia who have experienced 2 or more recurrent miscarriages and/or intra-uterine foetal death.

Protection of trial subjects

The trial was conducted in full conformance with the principles of the Declaration of Helsinki and ICH Good Clinical Practice (GCP) guidelines. The trial was reviewed and approved by the UK Competent Authority the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (REC). Participants were instructed on how to inject themselves with LMWH prior to administering their first dose of trial IMP. Refresher training was offered as appropriate.

Background therapy

Evidence for comparator

Actual start date of recruitment

11 Jan 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 192

Country: Number of subjects enrolled

Netherlands: 134

Worldwide total number of subjects

326

EEA total number of subjects

134

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

326

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

A total of 326 women were randomised to low-dose low-molecular-weight heparin or not, from 01/08/2012 to 30/01/2021 with a pause to recruitment due to the COVID-19 pandemic between 24/03/2020 to 09/06/2020. Women were registered and randomised from 40 sites across the Netherlands, the UK, the USA, Belgium, and Slovenia.

Screening details

In the Netherlands coordinated sites, eligible women were first registered into the trial, and only consented and randomised into the trial once their pregnancy had been confirmed. In total 428 women were registered and 326 of those randomised. Reported results are for the 326 randomised only.

Period 1 title

Overall study period (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Blinding implementation details

Participants and physicians were not blinded as this was an open-label study. Outcome assessors were also not blinded to the trial arm allocation.

Are arms mutually exclusive

Yes

Standard care

Arm description

Standard pregnancy surveillance

Arm type

No intervention

Investigational medicinal product name

No investigational medicinal product assigned in this arm

LMWH

Arm description

Low-molecular-weight Heparin administered

Arm type

Experimental

Investigational medicinal product name

Low Molecular Weight Heparins (LMWH)

Investigational medicinal product code

Other name

Enoxaparin, Dalteparin, Tinzaparin

Pharmaceutical forms

Dispersion for injection in pre-filled syringe

Routes of administration

Injection

Dosage and administration details

The investigational medicinal products in this study are enoxaparin, dalteparin and tinzaparin. All IMPs are classed as Low Molecular Weight Heparins (LMWH). LMWHs bind to anti-thrombin III leading to inhibition of coagulation factors IIa and Xa. Product of choice; Clexane (Sanofi-Aventis) Enoxaparin sodium 100mg/mL injection, 40mg in 0.4mL pre-filled syringe, or Inhixa (Techdow Pharma Ltd) Enoxaparin sodium 100mg/mL injection, 40mg in 0.4mL pre-filled syringe. If the treatment of choice is unavailable another type of LMWH in a dosage equivalent to Enoxaparin 40mg can be chosen from; Fragmin (Pfizer bv) Dalteparin sodium 25000 IU/ml injection, 5000 IU in 0.2mL pre-filled syringe, Innohep (Leo Pharma bv) Tinzaparin sodium 10000 IU/ml Injection, 4500 IU in 0.45mL pre-filled syringe. Participants will be instructed in how to inject themselves subcutaneously once daily with a dose of LMWH in either upper leg or abdomen, prior to administering their first dose of trial IMP.

Number of subjects in period 1	Standard care	LMWH
Started	162	164
Completed	158	162
Not completed	4	2
Consent withdrawn by subject	3	1
Missing primary endpoint	-	1
Lost to follow-up	1	-

Baseline characteristics

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Reporting group title

Standard care

Reporting group description

Standard pregnancy surveillance

Reporting group title

LMWH

Reporting group description

Low-molecular-weight Heparin administered

Reporting group values	Standard care	LMWH	Total
Number of subjects	162	164	326
Age categorical
Units: Subjects
>=36 years old	59	59	118
<36 years old	103	105	208
Age continuous
Units: years
arithmetic mean (standard deviation)	33.3 ± 5.3	33.5 ± 5.2	-
Gender categorical
Units: Subjects
Female	162	164	326
Male	0	0	0
Number of miscarriages
Number of miscarriages participant had previously had at randomisation
Units: Subjects
2 miscarriages	52	46	98
3 or more miscarriages	110	118	228
Tertiary centre
Units: Subjects
Yes	139	143	282
No	23	21	44
Randomising study team
Units: Subjects
UK	96	96	192
Netherlands	66	68	134

End points

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Reporting group title

Standard care

Reporting group description

Standard pregnancy surveillance

Reporting group title

LMWH

Reporting group description

Low-molecular-weight Heparin administered

Primary: Live birth after 24+0 weeks gestation

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End point title

Live birth after 24+0 weeks gestation

End point description

Primary outcome measure was live birth after 24+0 weeks gestation

End point type

Primary

End point timeframe

Live birth after 24+0 weeks gestation

End point values	Standard care	LMWH
Number of subjects analysed	158	162
Units: 320
Live birth	112	116
Pregnancy loss	46	46

Primary analysis (unadjusted)

Statistical analysis description

Unadjusted analysis reporting odds ratios (95% CI) and chi-squared p-value with continuity correction

Comparison groups

LMWH v Standard care

Number of subjects included in analysis

320

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.99 ^[1]

Method

Chi-squared corrected

Parameter type

Odds ratio (OR)

Point estimate

1.04

Confidence interval

level

95%

sides

2-sided

lower limit

0.64

upper limit

1.68

Notes
[1] - chi-squared p-value with continuity correction

Primary analysis (adjusted)

Statistical analysis description

Adjusted analysis reporting odds ratios (95% CI) and p-value using logistic regression adjusted for maternal age (<36 years, >=36 years), number of miscarriages (2, >=3), tertiary or non-tertiary centre, and randomising country (UK, Netherlands) with the standard surveillance group as the reference group

Comparison groups

Standard care v LMWH

Number of subjects included in analysis

320

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.77

Method

Regression, Logistic

Parameter type

Odds ratio (OR)

Point estimate

1.08

Confidence interval

level

95%

sides

2-sided

lower limit

0.65

upper limit

1.78

Adverse events

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Timeframe for reporting adverse events

Adverse events (AEs) were collected from Randomisation (<7 weeks gestation) to end of trial (6-8 weeks post outcome). Serious adverse events were collected by UK only (N=192)

Adverse event reporting additional description

AEs were collected systematically at the following intervals; 12 week visit, 24-26 week visit, 36 week visit, end of trial visit. An AE is defined as any untoward medical occurrence in a participant and which does not necessarily have a causal relationship with this treatment. Serious AEs were collected non-systematically throughout trial.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

4.0

Reporting group title

Standard care

Reporting group description

Standard pregnancy surveillance

Reporting group title

LMWH

Reporting group description

Low-molecular-weight Heparin administered

Serious adverse events	Standard care	LMWH
Total subjects affected by serious adverse events
subjects affected / exposed	4 / 162 (2.47%)	16 / 164 (9.76%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders - other
Additional description: Imperforate anus and RDS in baby
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
Thromboembolic event
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Cardiac disorders
Sinus tachycardia
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions - Other, specify
Additional description: (1)Meconium aspiration(2)Overnight admission-surgical management miscarriage(3)Surgical procedure-abdominal collection(4&5)Secondary PPH(6)Fetal decelerations via CTG(7)Spontaneous rupture of membrane &bleeding(8) Evac retained products of conception
alternative assessment type: Non-systematic
subjects affected / exposed	2 / 162 (1.23%)	5 / 164 (3.05%)
occurrences causally related to treatment / all	0 / 2	0 / 6
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
Diarrhoea
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	2 / 164 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Abdominal pain
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Vomiting
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	2 / 164 (1.22%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
Additional description: Salpingectomy
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Productive cough
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 162 (0.62%)	0 / 164 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Cough
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 162 (0.62%)	0 / 164 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Dyspnoea
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 162 (0.62%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 1	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Hypoxia
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Wheezing
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 162 (0.62%)	0 / 164 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Rash maculo-papular
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
Psychiatric disorders - Other, specify
Additional description: Severe bipolar disorder episode post delivery
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Renal and urinary disorders
Urinary retention
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Infections and infestations
Uterine infection
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 162 (0.62%)	0 / 164 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Bladder Infection
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Bronchial infection
alternative assessment type: Non-systematic
subjects affected / exposed	1 / 162 (0.62%)	0 / 164 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Lung infection
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Metabolism and nutrition disorders
Hyperkalemia
alternative assessment type: Non-systematic
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 0%

Non-serious adverse events	Standard care	LMWH
Total subjects affected by non serious adverse events
subjects affected / exposed	62 / 162 (38.27%)	85 / 164 (51.83%)
Vascular disorders
Phlebitis
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences all number	0	1
Vascular disorders - Other, specify
Additional description: Vulval varicocity
subjects affected / exposed	1 / 162 (0.62%)	0 / 164 (0.00%)
occurrences all number	1	0
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions - Other, specify
Additional description: (1) Cervix pessary (2) gestational hypertension (3-9) HELLP/or Pre-eclampsia (10) obstetric cholestasis (11-13) placental abruption
subjects affected / exposed	6 / 162 (3.70%)	6 / 164 (3.66%)
occurrences all number	6	7
General disorders and administration site conditions
General disorders and administration site conditions - Other, specify
Additional description: (1) Fainting (2) Feeling unwell, braxston hicks, pale, clammy
subjects affected / exposed	0 / 162 (0.00%)	2 / 164 (1.22%)
occurrences all number	0	2
Injection site reaction
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences all number	0	1
Pain
subjects affected / exposed	6 / 162 (3.70%)	7 / 164 (4.27%)
occurrences all number	6	10
Reproductive system and breast disorders
Pelvic pain
subjects affected / exposed	2 / 162 (1.23%)	0 / 164 (0.00%)
occurrences all number	2	0
Reproductive system and breast disorders - Other, specify
Additional description: (1-49) antenatal bleed (50-70) post-partum bleed (71) PV bleed
subjects affected / exposed	32 / 162 (19.75%)	30 / 164 (18.29%)
occurrences all number	37	34
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 162 (0.62%)	0 / 164 (0.00%)
occurrences all number	1	0
Epistaxis
subjects affected / exposed	6 / 162 (3.70%)	7 / 164 (4.27%)
occurrences all number	7	8
Respiratory, thoracic and mediastinal disorders - Other, specify
Additional description: Exacerbation of asthma
subjects affected / exposed	1 / 162 (0.62%)	0 / 164 (0.00%)
occurrences all number	1	0
Investigations
Investigations - Other, specify
Additional description: (1) low papa (2-3) Scan for DVT (4) Vaginal discharge - green/brown
subjects affected / exposed	4 / 162 (2.47%)	0 / 164 (0.00%)
occurrences all number	4	0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	1 / 162 (0.62%)	1 / 164 (0.61%)
occurrences all number	1	1
Injury, poisoning and procedural complications - Other, specify
Additional description: Spot of blood noted at injection site
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences all number	0	1
Bruising
subjects affected / exposed	12 / 162 (7.41%)	53 / 164 (32.32%)
occurrences all number	16	76
Nervous system disorders
Headache
subjects affected / exposed	0 / 162 (0.00%)	3 / 164 (1.83%)
occurrences all number	0	3
Blood and lymphatic system disorders
Anemia
subjects affected / exposed	2 / 162 (1.23%)	0 / 164 (0.00%)
occurrences all number	2	0
Blood and lymphatic system disorders - Other, specify
Additional description: venous thromboembolism
subjects affected / exposed	1 / 162 (0.62%)	0 / 164 (0.00%)
occurrences all number	1	0
Gastrointestinal disorders
Constipation
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences all number	0	1
Diarrhoea
subjects affected / exposed	1 / 162 (0.62%)	1 / 164 (0.61%)
occurrences all number	1	1
Gastrointestinal disorders - Other, specify
Additional description: (1) abdominal pain (2) acid reflux (3) obstetric cholestasis (4) oral thrush
subjects affected / exposed	1 / 162 (0.62%)	2 / 164 (1.22%)
occurrences all number	1	3
Nausea
subjects affected / exposed	1 / 162 (0.62%)	8 / 164 (4.88%)
occurrences all number	1	8
Rectal haemorrhage
subjects affected / exposed	1 / 162 (0.62%)	1 / 164 (0.61%)
occurrences all number	1	1
Vomiting
subjects affected / exposed	2 / 162 (1.23%)	2 / 164 (1.22%)
occurrences all number	2	2
Skin and subcutaneous tissue disorders
pregnancy associated rash
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences all number	0	1
Skin and subcutaneous tissue disorders - Other, specify
Additional description: (1) brown spots on legs (2) Haemorrhoids (3-4) Itching (5-10) Mild skin reaction (11-12) Subcuticular bleed
subjects affected / exposed	2 / 162 (1.23%)	9 / 164 (5.49%)
occurrences all number	2	10
Renal and urinary disorders
Hematuria
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences all number	0	1
Urinary incontinence
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences all number	0	1
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
Additional description: (1) cramp (2) right leg sciatica
subjects affected / exposed	0 / 162 (0.00%)	2 / 164 (1.22%)
occurrences all number	0	2
Infections and infestations
Infections and infestations - Other, specify
Additional description: (1-5) Chest infections (6) Ear infection (7) Infection of Perineal region (8) Shingles (9) Tonsillitis
subjects affected / exposed	2 / 162 (1.23%)	6 / 164 (3.66%)
occurrences all number	2	7
Tooth infection
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences all number	0	1
Urinary tract infection
subjects affected / exposed	3 / 162 (1.85%)	2 / 164 (1.22%)
occurrences all number	3	2
Wound infection
subjects affected / exposed	1 / 162 (0.62%)	3 / 164 (1.83%)
occurrences all number	1	3
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	1 / 162 (0.62%)	0 / 164 (0.00%)
occurrences all number	1	0
Metabolism and nutrition disorders - Other, specify
Additional description: Gestational diabetes
subjects affected / exposed	0 / 162 (0.00%)	1 / 164 (0.61%)
occurrences all number	0	1

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? Yes

Date	Interruption	Restart date
24 Mar 2020	Recruitment to the trial was paused for 3 months due to the COVID-19 pandemic.	09 Jun 2020

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

http://www.ncbi.nlm.nih.gov/pubmed/37271152

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Clinical trials

Clinical Trial Results:
Anticoagulants for Living FoEtuses in women with recurrent miscarriage and inherited thrombophilia : ALIFE 2

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Live birth after 24+0 weeks gestation

Primary: Live birth after 24+0 weeks gestation

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

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Clinical trials

Clinical Trial Results: Anticoagulants for Living FoEtuses in women with recurrent miscarriage and inherited thrombophilia : ALIFE 2

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Live birth after 24+0 weeks gestation

Primary: Live birth after 24+0 weeks gestation

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Online references

More information

Clinical Trial Results:
Anticoagulants for Living FoEtuses in women with recurrent miscarriage and inherited thrombophilia : ALIFE 2