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OpenTrials
Completed

NCT Number: NCT03601338

Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound

Completed

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Key information

Conditions

Unexplained Stillbirth

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Hawler Medical University

Erbil, Kurdistan Region, 44001, Iraq

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bemiparin

Drug

second generation low molecular weight Heparin

Other names: Hibor

multivitamins and routine antenatal follow up

Other

multivitamins and routine antenatal follow up

Primary outcomes

  1. Stillbirth

    Time frame: after 20 weeks gestation to the delivery of fetus

    Intrauterine fetal death

  2. Early neonatal death

    Time frame: First week of life

    Death of newborn

  3. Low birth weight

    Time frame: first hour of life

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

Secondary outcomes

  1. Preterm labor

    Time frame: 20-37 weeks

    delivery of the fetus before 37 weeks gestation

  2. Pre-eclampsia

    Time frame: 20-41 week gestation

    High blood pressure with protein urea

  3. major abruptio placenta

    Time frame: 20-41 week gestation

    Antepartum hemorrhage

Sponsors and collaborators

Lead sponsor

Hawler Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2018
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.