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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enoxaparin Group | Experimental | Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery. |
|
| Standard Management Group | Experimental | Patients will continue with standard management alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enoxaparin | Drug | Patients will receive standard management plus enoxaparin 40 mg subcutaneously once daily until delivery |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maimoona Hafeez | Contact | +923135495729 | maimoonahafeez777@gmail.com | |
| Sidra Iqbal, FCPS | Contact | +923336391038 | drsidraiqbal4@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Maimoona Hafeez | Combined Military Hospital Quetta | Principal Investigator |
| Sidra Iqbal, FCPS | Combined Military Hospital Quetta | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Military Hospital | Quetta | Balochistan | 80000 | Pakistan |
Data can be shared on a reasonable request.
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Standard Management | Other | Patients will continue with standard management alone. |
|
| 7 days |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002241 |
| Carbohydrates |