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RecruitingNCT04861103Updated Oct 29, 2025

Anticoagulation Profile in Pregnant Women Treated With Three Times a Day of Low Molecular Weight Heparin (LMWH)

A Phase 4 interventional study of Lovenox in Pregnancy, High Risk and Anticoagulants, sponsored by University of California, Irvine. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-29.

Sponsored by University of California, Irvine · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Oct 2020, registered Apr 2021).
  • Started Oct 2020; still recruiting 6 years later.
Phase
Phase 4
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

Pregnancy is associated with a increased risk of developing blood clots. There is nearly a 5 times greater risk of developing a blood clot in pregnancy. Lovenox is a medication that helps to prevent the body from developing clots. It is safe to use in pregnancy. Previous studies have demonstrated that despite recommendation of Lovenox, to prevent blood clots, the majority of patient's (70 to 90%) did not receive adequate levels of Lovenox at times throughout the day, which likely increases the risk of developing clots. The increase in blood volume and increase in kidney function that occurs in pregnancy may contribute to the inadequate levels. Currently the recommendation for pregnant and nonpregnant patients requiring Lovenox, is to calculate the daily dose of Lovenox and split the dose, giving half in the morning and the other half in the evening. This research study proposes that due to changes in the body during pregnancy that the daily Lovenox dosing be split into three times a day to achieve more consistent levels of Lovenox than twice a day in pregnant women.

02

Conditions studied

  • Pregnancy, High Risk
  • Anticoagulants
03

In context

Lead sponsor

University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.

Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Nulliparous or multiparous women with single intrauterine pregnancies who require therapeutic low molecular weight heparin during their pregnancy.
  • Participants must be age 18 or older.

Exclusion criteria

Exclusion Criteria:

  • Women with multiples.
  • Women less than age 18
  • History of Heparin Induced Thrombocytopenia (HIT)
  • Allergy to enoxaparin
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Factor Xa levels in pregnant women with therapeutic Lovenox divided into three times a day dosing

    Therapeutic Lovenox dosing split into three times a day dosing for 5 day. Xa levels a measured.

    Drug: Lovenox

Interventions

  • DrugLovenox

    Three times a day dosing and measuring Xa peak and trough levels

06

What researchers measure

Primary outcomes

  1. Factor Xa levels

    Time frame: 4 hours after injection

07

Study locations

1 of 1 sites recruiting
  • University of California Irvine
    Orange, California 92868, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04861103
Lead sponsor
University of California, Irvine
Responsible party
Afshan B. Hameed, M.D. (Maternal Fetal Medicine Physician, University of California, Irvine) — Principal investigator
First posted
Apr 27, 2021
Start date
Oct 1, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Jul 31, 2027 (estimated)
Last update
Oct 29, 2025

Study contacts

Lizette Spears
Contact
lspiers@hs.uci.edu
714.456.5694
Afshan Hameed
principal investigator · University of California, Irvine

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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