Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction

Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction With Oligohydramnios.

The local literature lacks comprehensive information regarding the actual incidence of intrauterine growth restriction (IUGR) and oligohydramnios and currently available therapeutic options. Therefore, the current study was planned with the objective to evaluate the impact of enoxaparin therapy compared with standard management on neonatal outcomes in pregnancies complicated by intrauterine growth restriction (IUGR) with oligohydramnios.

Study Overview

• Status: Not yet recruiting
• Conditions: Intrauterine Growth Restriction
• Intervention / Treatment: Drug: Enoxaparin; Other: Standard Management

Detailed Description

The use of enoxaparin is not yet a standard practice in pregnancies with IUGR and oligohydramnios without overt maternal thrombophilia. Given the notable incidence of IUGR and oligohydramnios and the limited therapeutic options currently available, exploring the potential benefits of enoxaparin therapy against standard management is both clinically and socially relevant. By investigating whether enoxaparin can improve fetal outcomes in this high-risk group, the findings of this study would generate evidence that could inform future management protocols, reduce preventable perinatal morbidity and mortality, and ultimately improve neonatal survival and health in Pakistan.

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maimoona Hafeez; Phone Number: +923135495729; Email: maimoonahafeez777@gmail.com
• Study Contact Backup: Name: Sidra Iqbal, FCPS; Phone Number: +923336391038; Email: drsidraiqbal4@gmail.com

Study Locations

• Pakistan
  • Balochistan
    • Quetta, Balochistan, Pakistan, 80000
      • Combined Military Hospital
      • Contact: Maimoona Hafeez; Phone Number: +923135495729; Email: maimoonahafeez777@gmail.com
      • Contact: Sidra Iqbal, PCPS; Phone Number: +923336391038; Email: drsidraiqbal4@gmail.com
      • Principal Investigator: Maimoona Hafeez
      • Principal Investigator: Sidra Iqbal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women aged 18-40 years
• Singleton pregnancy
• Gestational age ≥28 weeks (confirmed by first-trimester scan or reliable last menstrual period)
• Diagnosed with both IUGR and oligohydramnios
• Willing to provide informed written consent

Exclusion Criteria:

• Multiple gestation
• Major fetal congenital anomalies
• Maternal medical disorders affecting pregnancy outcome (e.g., uncontrolled diabetes, chronic hypertension, renal disease)
• Known coagulation disorders or contraindications to enoxaparin
• Women already on anticoagulation therapy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enoxaparin Group; Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery.	Drug: Enoxaparin; Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery; Other: Standard Management; Patients will continue with standard management alone.
Experimental: Standard Management Group; Patients will continue with standard management alone.	Other: Standard Management; Patients will continue with standard management alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth	The frequency of live birth will be noted. Delivery of a baby with signs of life at birth, irrespective of gestational age will be considered as live birth.	12 weeks
Low Birth weight	Frequency of low birth weight will be noted. Neonatal birth weight <2.5 kg will be documented as low birth weight.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Intensive Care Unit Admission	The frequency of admission to the neonatal intensive care unit will be noted.	7 days
Perinatal Mortality	Perinatal mortality will be labeled "yes" if there is a stillbirth or neonatal death within the first 7 days of life.	7 days

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Principal Investigator: Maimoona Hafeez, Combined Military Hospital Quetta; Study Director: Sidra Iqbal, FCPS, Combined Military Hospital Quetta

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Fetal Diseases; Growth Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Fetal Growth Retardation; Carbohydrates; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Enoxaparin
• Other Study ID Numbers: Dr-Maimoona-Quetta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared 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