Low Molecular Weight Heparin in Pregnancies With Unexplained Stillbirths

Hawler Medical University

Status and phase: Completed; Early Phase 1

Conditions: Unexplained Stillbirth

Treatments: Other: multivitamins and routine antenatal follow up; Drug: Bemiparin

Study type: Interventional

Funder types: Other

Identifiers

NCT03601338

HawlerMU2.7

Details and patient eligibility

About

Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound

Full 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 .

Enrollment: 140 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups, including a placebo group

Bemiparin group

Active Comparator group

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

Treatment:

Drug: Bemiparin

control group

Placebo Comparator group

Description:

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

Treatment:

Other: multivitamins and routine antenatal follow up