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Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

NCT ID: NCT03601338

Last Updated: 2018-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2018-12-06

Brief Summary

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Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound

Detailed Description

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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 .

Conditions

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Unexplained Stillbirth

Keywords

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Unexplained stillbirth Low molecular Weight Heparin Umbilical artery Doppler Ultrasound Antenatal care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

pregnant women with history of unexplained fetal death
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Bemiparin

Intervention Type DRUG

second generation low molecular weight Heparin

control group

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

Group Type PLACEBO_COMPARATOR

multivitamins and routine antenatal follow up

Intervention Type OTHER

multivitamins and routine antenatal follow up

Interventions

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Bemiparin

second generation low molecular weight Heparin

Intervention Type DRUG

multivitamins and routine antenatal follow up

multivitamins and routine antenatal follow up

Intervention Type OTHER

Other Intervention Names

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Hibor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hawler Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shahla Alalaf

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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shahla k. Alalaf, M.D

Role: PRINCIPAL_INVESTIGATOR

Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology

Ariana K. Jawad, CABOG

Role: STUDY_DIRECTOR

Kurdistan Board for Medical Specialist

Mahabad S. Ali, Diploma

Role: STUDY_CHAIR

Maternity Teaching Hospital

Locations

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Hawler Medical University

Erbil, Kurdistan Region, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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HawlerMU2.7

Identifier Type: -

Identifier Source: org_study_id