Trial | NCT03601338  Report issue

Title

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

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    bemiparin ...

  • Study Participants

    140
Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound
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 Started
Aug 01
2015
Primary Completion
Dec 01
2018
Study Completion
Dec 06
2018
Last Update
Dec 10
2018

Drug Bemiparin

second generation low molecular weight Heparin

  • Other names: Hibor

Other multivitamins and routine antenatal follow up

multivitamins and routine antenatal follow up

Bemiparin group Active Comparator

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

control group Placebo Comparator

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

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
No Results Posted