Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

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

Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound

Study Overview

• Status: Completed
• Conditions: Unexplained Stillbirth
• Intervention / Treatment: Drug: Bemiparin; Other: multivitamins and routine antenatal follow up

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 .

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan Region
    • Erbil, Kurdistan Region, Iraq, 44001
      • Hawler Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bemiparin group; 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; second generation low molecular weight Heparin; Other Names: Hibor
Placebo Comparator: control group; Normal umbilical arty resistant index group received only multivitamins and routine antenatal follow up	Other: multivitamins and routine antenatal follow up; multivitamins and routine antenatal follow up

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Investigators: Principal Investigator: shahla k. Alalaf, M.D, Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology; Study Director: Ariana K. Jawad, CABOG, Kurdistan Board for Medical Specialist; Study Chair: Mahabad S. Ali, Diploma, Maternity Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 6, 2018

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 25, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 7, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Doppler Ultrasound; Antenatal care; Umbilical artery; Unexplained stillbirth; Low molecular Weight Heparin
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Fetal Death; Stillbirth; Anticoagulants; Bemiparin
• Other Study ID Numbers: HawlerMU2.7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No