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Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

Primary Purpose

Unexplained Stillbirth

Status
Completed
Phase
Early Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Bemiparin
multivitamins and routine antenatal follow up
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Unexplained Stillbirth focused on measuring Unexplained stillbirth, Low molecular Weight Heparin, Umbilical artery, Doppler Ultrasound, Antenatal care

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hawler Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bemiparin group

control group

Arm Description

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

Normal umbilical arty resistant index group received only multivitamins and routine antenatal follow up

Outcomes

Primary Outcome Measures

Stillbirth
Intrauterine fetal death
Early neonatal death
Death of newborn
Low birth weight
New borne with birth weight less than 5th percentile in kilogram

Secondary Outcome Measures

Preterm labor
delivery of the fetus before 37 weeks gestation
Pre-eclampsia
High blood pressure with protein urea
major abruptio placenta
Antepartum hemorrhage

Full Information

First Posted
July 18, 2018
Last Updated
December 7, 2018
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03601338
Brief Title
Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Stillbirth
Keywords
Unexplained stillbirth, Low molecular Weight Heparin, Umbilical artery, Doppler Ultrasound, Antenatal care

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
pregnant women with history of unexplained fetal death
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bemiparin group
Arm Type
Active Comparator
Arm Description
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
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Normal umbilical arty resistant index group received only multivitamins and routine antenatal follow up
Intervention Type
Drug
Intervention Name(s)
Bemiparin
Other Intervention Name(s)
Hibor
Intervention Description
second generation low molecular weight Heparin
Intervention Type
Other
Intervention Name(s)
multivitamins and routine antenatal follow up
Intervention Description
multivitamins and routine antenatal follow up
Primary Outcome Measure Information:
Title
Stillbirth
Description
Intrauterine fetal death
Time Frame
after 20 weeks gestation to the delivery of fetus
Title
Early neonatal death
Description
Death of newborn
Time Frame
First week of life
Title
Low birth weight
Description
New borne with birth weight less than 5th percentile in kilogram
Time Frame
first hour of life
Secondary Outcome Measure Information:
Title
Preterm labor
Description
delivery of the fetus before 37 weeks gestation
Time Frame
20-37 weeks
Title
Pre-eclampsia
Description
High blood pressure with protein urea
Time Frame
20-41 week gestation
Title
major abruptio placenta
Description
Antepartum hemorrhage
Time Frame
20-41 week gestation

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shahla k. Alalaf, M.D
Organizational Affiliation
Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ariana K. Jawad, CABOG
Organizational Affiliation
Kurdistan Board for Medical Specialist
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahabad S. Ali, Diploma
Organizational Affiliation
Maternity Teaching Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hawler Medical University
City
Erbil
State/Province
Kurdistan Region
ZIP/Postal Code
44001
Country
Iraq

12. IPD Sharing Statement

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Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

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