NCT02856295

Brief Summary

The aim of this study is to compare between anti-10a levels in postpartum women receiving different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's weight and the second group receiving 1mg/kg to a maximum dose of 120 mg

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

July 13, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
5.3 years until next milestone

Study Start

First participant enrolled

November 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

July 13, 2016

Last Update Submit

November 10, 2022

Conditions

Venous Thromboembolism

Keywords

postpartum venous thromboembolismprophylactic dose of low molecular weight heparinanti 10a

Outcome Measures

Primary Outcomes (1)

  • clexane dosing method in order to achieve anti 10a level >0.2

    4 hour after the women receive the drug

Secondary Outcomes (3)

  • incidence of anti 10a level of >0.6

    4 hour after the women receive the drug

  • incidence of vein thromboembolism

    during the six weeks after delivery

  • incidence of bleeding events

    during the six weeks after delivery

Study Arms (2)

clexane according to weight group

ACTIVE COMPARATOR

clexane dose adjusted for woman's weight according to: weight \< 90 kg - 40mg, 91-130kg - 60 mg, 131-170kg - 80mg, \>170kg-100mg.

Drug: clexane (LMWH)

clexane mg per kg

ACTIVE COMPARATOR

clexane dose of 1mg/kg up to 120 mg

Drug: clexane (LMWH)

Interventions

clexane (LMWH)DRUG

to compare tow doses of clexane for preventing VTE in postpartum women

clexane according to weight groupclexane mg per kg

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • postpartum women supposed to receive LMWH according to obstetric indications

You may not qualify if:

  • known allergy to clexane
  • active bleeding postpartum
  • thrombocytopenia \< 75000
  • recent cerebrovascular accident / transient ischemic attack (\<4 weeks)
  • glomerular filtration rate) \< 30 ml/min)
  • active liver disease
  • malignant hypertension (systolic \> 200 mmHg, diastolic\> 120 mmHg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emek medical center

Afula, Israel

Location

Related Publications (16)

  • Bremme KA. Haemostatic changes in pregnancy. Best Pract Res Clin Haematol. 2003 Jun;16(2):153-68. doi: 10.1016/s1521-6926(03)00021-5.

    PMID: 12763484RESULT

  • Hellgren M. Hemostasis during normal pregnancy and puerperium. Semin Thromb Hemost. 2003 Apr;29(2):125-30. doi: 10.1055/s-2003-38897.

    PMID: 12709915RESULT

  • Practice bulletin no. 124: inherited thrombophilias in pregnancy. Obstet Gynecol. 2011 Sep;118(3):730-740. doi: 10.1097/AOG.0b013e3182310c6f.

    PMID: 21860314RESULT

  • Scifres CM, Macones GA. The utility of thrombophilia testing in pregnant women with thrombosis: fact or fiction? Am J Obstet Gynecol. 2008 Oct;199(4):344.e1-7. doi: 10.1016/j.ajog.2008.04.051. Epub 2008 Jun 24.

    PMID: 18572147RESULT

  • Gherman RB, Goodwin TM, Leung B, Byrne JD, Hethumumi R, Montoro M. Incidence, clinical characteristics, and timing of objectively diagnosed venous thromboembolism during pregnancy. Obstet Gynecol. 1999 Nov;94(5 Pt 1):730-4. doi: 10.1016/s0029-7844(99)00426-3.

    PMID: 10546719RESULT

  • Chang J, Elam-Evans LD, Berg CJ, Herndon J, Flowers L, Seed KA, Syverson CJ. Pregnancy-related mortality surveillance--United States, 1991--1999. MMWR Surveill Summ. 2003 Feb 21;52(2):1-8.

    PMID: 12825542RESULT

  • Heit JA, Kobbervig CE, James AH, Petterson TM, Bailey KR, Melton LJ 3rd. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med. 2005 Nov 15;143(10):697-706. doi: 10.7326/0003-4819-143-10-200511150-00006.

    PMID: 16287790RESULT

  • Pomp ER, Lenselink AM, Rosendaal FR, Doggen CJ. Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study. J Thromb Haemost. 2008 Apr;6(4):632-7. doi: 10.1111/j.1538-7836.2008.02921.x. Epub 2008 Jan 31.

    PMID: 18248600RESULT

  • McColl MD, Walker ID, Greer IA. The role of inherited thrombophilia in venous thromboembolism associated with pregnancy. Br J Obstet Gynaecol. 1999 Aug;106(8):756-66. doi: 10.1111/j.1471-0528.1999.tb08395.x.

    PMID: 10453824RESULT

  • Bates SM, Greer IA, Middeldorp S, Veenstra DL, Prabulos AM, Vandvik PO. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e691S-e736S. doi: 10.1378/chest.11-2300.

    PMID: 22315276RESULT

  • American College of Obstetricians and Gynecologists. ACOG Committee Opinion: safety of Lovenox in pregnancy. Obstet Gynecol. 2002 Oct;100(4):845-6.

    PMID: 12387283RESULT

  • Bain E, Wilson A, Tooher R, Gates S, Davis LJ, Middleton P. Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2014 Feb 11;(2):CD001689. doi: 10.1002/14651858.CD001689.pub3.

    PMID: 24519568RESULT

  • Bates SM, Greer IA, Hirsh J, Ginsberg JS. Use of antithrombotic agents during pregnancy: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):627S-644S. doi: 10.1378/chest.126.3_suppl.627S.

    PMID: 15383488RESULT

  • Shapiro NL, Kominiarek MA, Nutescu EA, Chevalier AB, Hibbard JU. Dosing and monitoring of low-molecular-weight heparin in high-risk pregnancy: single-center experience. Pharmacotherapy. 2011 Jul;31(7):678-85. doi: 10.1592/phco.31.7.678.

    PMID: 21923455RESULT

  • Fox NS, Laughon SK, Bender SD, Saltzman DH, Rebarber A. Anti-factor Xa plasma levels in pregnant women receiving low molecular weight heparin thromboprophylaxis. Obstet Gynecol. 2008 Oct;112(4):884-9. doi: 10.1097/AOG.0b013e31818638dc. Erratum In: Obstet Gynecol. 2009 Mar;113(3):742.

    PMID: 18827132RESULT

  • Haj R, Massalha M, Eitam H, Kassabri R, Yefet E, Nachum Z. Comparison of postpartum anti-Xa levels following enoxaparin administration to prevent venous thromboembolism using 2 weight-based protocols: a randomized controlled trial. Am J Obstet Gynecol MFM. 2023 Aug;5(8):100988. doi: 10.1016/j.ajogmf.2023.100988. Epub 2023 May 6.

    PMID: 37156466DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

EnoxaparinHeparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Zohar Nachum, M.D

    Emek Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 13, 2016

First Posted

August 4, 2016

Study Start

November 20, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Locations

IL(1)