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Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

Early Phase 1
Completed
Conditions
Unexplained Stillbirth
Interventions
Other: multivitamins and routine antenatal follow up
Registration Number
NCT03601338
Lead Sponsor
Hawler Medical University
Brief Summary

Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound

Detailed Description

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 .

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
140
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
control groupmultivitamins and routine antenatal follow upNormal umbilical arty resistant index group received only multivitamins and routine antenatal follow up
Bemiparin groupBemiparinWomen 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
Primary Outcome Measures
NameTimeMethod
Stillbirthafter 20 weeks gestation to the delivery of fetus

Intrauterine fetal death

Early neonatal deathFirst week of life

Death of newborn

Low birth weightfirst hour of life

New borne with birth weight less than 5th percentile in kilogram

Secondary Outcome Measures
NameTimeMethod
major abruptio placenta20-41 week gestation

Antepartum hemorrhage

Pre-eclampsia20-41 week gestation

High blood pressure with protein urea

Preterm labor20-37 weeks

delivery of the fetus before 37 weeks gestation

Trial Locations

Locations (1)

Hawler Medical University

🇮🇶

Erbil, Kurdistan Region, Iraq

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