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NCT Number: NCT07462182

Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enoxaparin

Drug

Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery

Standard management

Other

Patients will continue with standard management alone.

Primary outcomes

  1. Live birth

    Time frame: 12 weeks

    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.

  2. Low Birth weight

    Time frame: 12 weeks

    Frequency of low birth weight will be noted. Neonatal birth weight <2.5 kg will be documented as low birth weight.

Secondary outcomes

  1. Neonatal Intensive Care Unit Admission

    Time frame: 7 days

    The frequency of admission to the neonatal intensive care unit will be noted.

  2. Perinatal Mortality

    Time frame: 7 days

    Perinatal mortality will be labeled "yes" if there is a stillbirth or neonatal death within the first 7 days of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Maimoona Hafeez

CONTACT

[email protected]

+923135495729

Sidra Iqbal, FCPS

CONTACT

[email protected]

+923336391038

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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