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
1 other identifier
interventional
140
1 country
1
Brief Summary
Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2015
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 18, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2018
CompletedDecember 10, 2018
December 1, 2018
3.3 years
July 18, 2018
December 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Preterm labor
20-37 weeks
Pre-eclampsia
20-41 week gestation
major abruptio placenta
20-41 week gestation
Study Arms (2)
Bemiparin group
ACTIVE COMPARATORWomen 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
control group
PLACEBO COMPARATORNormal umbilical arty resistant index group received only multivitamins and routine antenatal follow up
Interventions
multivitamins and routine antenatal follow up
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Confirmed thrombophilia
- Twin pregnancies
- Refused to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hawler Medical University
Erbil, Kurdistan Region, 44001, Iraq
MeSH Terms
Interventions
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
July 18, 2018
First Posted
July 26, 2018
Study Start
August 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 6, 2018
Last Updated
December 10, 2018
Record last verified: 2018-12