Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Enoxaparin, Standard Management.
- Who it may be relevant to
- Registry conditions: Intrauterine Growth Restriction. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Enoxaparin Therapy on Fetal Outcomes in Intrauterine Growth Restriction With Oligohydramnios.
Overview
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
- 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.
Primary outcome measures
- Live birth [Time frame: 12 weeks]
- Low Birth weight [Time frame: 12 weeks]
Secondary outcome measures (2)
- Neonatal Intensive Care Unit Admission [Time frame: 7 days]
- Perinatal Mortality [Time frame: 7 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Combined Military Hospital — Quetta
Identifiers
NCT: NCT07462182 · Dr-Maimoona-Quetta