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

NCT06484634 | Completed

• 1 other identifier: LMWHDGKHAN
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

• Efficacy of Low-Molecular-Weight Heparin

  Efficacy was labeled as yes in terms of live births after the age of viability, i.e., 24 weeks of gestation.

  32 weeks

Study Arms (2)

LMWH Group

EXPERIMENTAL

Women received a daily dose of 40 mg of Low Molecular Weight Heparin subcutaneously.

Drug: Low molecular weight heparin

Control

NO INTERVENTION

Women received the placebo in the form of a multivitamin tablet.

Interventions

Low molecular weight heparin DRUG

A daily dose of 40 mg of low-molecular-weight heparin (LMWH) subcutaneously was given to the patients.

LMWH Group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

DG Khan Hospital

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Location

MeSH Terms

Interventions

Heparin, Low-Molecular-Weight

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: December 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)