Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

Unexplained Stillbirth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03601338
• Other study ID #: HawlerMU2.7
• Status: Completed
• Phase: Early Phase 1
• Start date: August 1, 2015
• Est. completion date: December 6, 2018

Study information

• Verified date: December 2018
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound

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 information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 6, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Stillbirth
• Unexplained Stillbirth

Intervention

Drug:
• Bemiparin
second generation low molecular weight Heparin

Other:
• multivitamins and routine antenatal follow up
multivitamins and routine antenatal follow up

Locations

Country	Name	City	State
Iraq	Hawler Medical University	Erbil	Kurdistan Region

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stillbirth	Intrauterine fetal death	after 20 weeks gestation to the delivery of fetus
Primary	Early neonatal death	Death of newborn	First week of life
Primary	Low birth weight	New borne with birth weight less than 5th percentile in kilogram	first hour of life
Secondary	Preterm labor	delivery of the fetus before 37 weeks gestation	20-37 weeks
Secondary	Pre-eclampsia	High blood pressure with protein urea	20-41 week gestation
Secondary	major abruptio placenta	Antepartum hemorrhage	20-41 week gestation