Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

Study Overview
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Brief Summary
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Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound

Detailed Description
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152 women with history of unexplained stillbirths were identified , umbilical arty Doppler ultrasound was conducted for them at 20-22 weeks gestation . they were divided into two group , group one are those with abnormal resistant index (= or more than 0.6) thy received Bemiparin 2500 IU subcutaneously daily up to 24 hours before delivery . Group 2 with normal umbilical artery resistant index received no any interventions just routine antenatal follow up .

Official Title
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Second Generation Low Molecular Weight Heparin (Bemiparin) as a Prophylactic for Management of Subsequent Pregnancy After an Unexplained Stillbirth: A Clinical Comparative Study

Conditions
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Unexplained Stillbirth

Intervention / Treatment
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* Drug: Bemiparin
* Other: multivitamins and routine antenatal follow up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Second pregnancy after previous unexplained fetal death Singleton pregnancy No any medical disorders during pregnancy like diabetes or Systemic Lupus Erythematosus Normally located placenta No congenital fetal anomalies Patient accept to participate Exclusion Criteria: Confirmed thrombophilia Twin pregnancies Refused to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: pregnant women with history of unexplained fetal death
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bemiparin group<br>Women with high resistant index of umbilical artery received the intervention Bemiparin Sodium 2,500 IU anti Xa/0.2 ml solution for injection in pre-filled syringe provided for each woman . The injections were received daily since 20 weeks gestation and up to 24 hours before delivery Other Name: Hibor; Laboratories Rovi pharmaceuticals | Drug: Bemiparin<br>* second generation low molecular weight Heparin<br>* Other names: Hibor;|
| Placebo Comparator: control group<br>Normal umbilical arty resistant index group received only multivitamins and routine antenatal follow up | Other: multivitamins and routine antenatal follow up<br>* multivitamins and routine antenatal follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stillbirth | Intrauterine fetal death | after 20 weeks gestation to the delivery of fetus | 
| Early neonatal death | Death of newborn | First week of life | 
| Low birth weight | New borne with birth weight less than 5th percentile in kilogram | first hour of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm labor | delivery of the fetus before 37 weeks gestation | 20-37 weeks | 
| Pre-eclampsia | High blood pressure with protein urea | 20-41 week gestation | 
| major abruptio placenta | Antepartum hemorrhage | 20-41 week gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unexplained stillbirth, Low molecular Weight Heparin, Umbilical artery, Doppler Ultrasound, Antenatal care