Role of Low-Molecular-Weight Heparin in Unexplained Recurrent Pregnancy Loss

June 26, 2024 updated by: RESnTEC, Institute of Research
Using low-molecular-weight heparin (LMWH), outcomes such as live birth rate and the occurrence of pregnancy complications are some of the variables reported in some studies, with varying degrees of success. The present study aimed to compare the role of LMWH in unexplained recurrent pregnancy loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Dera Ghazi Khan, Punjab, Pakistan, 32200
        • DG Khan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant females between 18 and 44 years of age
  • Gestational age above 8 weeks
  • A history of ≥3 consecutive first trimester pregnancy losses

Exclusion Criteria:

  • Patients with systemic lupus erythematosus
  • Positive IgG and IgM anticardiolipin antibodies
  • Positive for thrombophilia screening
  • Any platelet function abnormality or a previous thromboembolic event requiring anticoagulant therapy (including heparin, aspirin or warfarin)
  • Sensitive to acetylsalicylic acid, heparin, or warfarin
  • Patients with any genetic, anatomical, or hormonal cause of recurrent pregnancy loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LMWH Group
Women received a daily dose of 40 mg of Low Molecular Weight Heparin subcutaneously.
Drug: Low molecular weight heparin
A daily dose of 40 mg of low-molecular-weight heparin (LMWH) subcutaneously was given to the patients.
No Intervention: Control
Women received the placebo in the form of a multivitamin tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of Low-Molecular-Weight Heparin
Time Frame: 32 weeks
Efficacy was labeled as yes in terms of live births after the age of viability, i.e., 24 weeks of gestation.
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RESnTEC, Institute of Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

June 26, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

June 26, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMWHDGKHAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data can be shared with other researchers on a reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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