Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07462182

Enrollment

108

Registered

2026-03-10

Start date

2026-04-01

Completion date

2026-09-30

Last updated

2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Growth Restriction

Brief summary

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.

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.

Interventions

DRUGEnoxaparin

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

OTHERStandard Management

Patients will continue with standard management alone.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Live birth	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.
Low Birth weight	12 weeks	Frequency of low birth weight will be noted. Neonatal birth weight \<2.5 kg will be documented as low birth weight.

Secondary

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

Countries

Pakistan

Contacts

CONTACTMaimoona Hafeez

maimoonahafeez777@gmail.com+923135495729

CONTACTSidra Iqbal, FCPS

drsidraiqbal4@gmail.com+923336391038

PRINCIPAL_INVESTIGATORMaimoona Hafeez

Combined Military Hospital Quetta

STUDY_DIRECTORSidra Iqbal, FCPS