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Report for Clinical Trial NCT00400387

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase III Study Analyzing the Effectiveness of Dalteparin Therapy as Intervention in Recurrent Pregnancy Loss

With this clinical trial the investigators will analyze whether the rate of pregnancy losses before the 24th week of gestation can be reduced by dalteparin treatment in habitual aborters.

NCT00400387 Abortion, Habitual
MeSH: Abortion, Habitual

2 Interventions

Name: Fragmin P Forte (dalteparin sodium)

Description: subcutaneous injection, once daily supported by multivitamine supplement and close monitoring

Type: Drug

Multivitamin supplement + dalteparin sodium

Name: Multivitamin supplement

Description: general pregnancy support by multivitamin supplementation and close monitoring

Type: Dietary Supplement

Multivitamin supplement


Primary Outcomes

Measure: ongoing intact pregnancy at 24 weeks of gestation

Time: at 24 weeks of gestation

Secondary Outcomes

Measure: late pregnancy complication, defined as at least one of the following: preterm delivery, placenta insufficiency, intrauterine growth retardation, preeclampsia and abruptio placentae

Time: 6-8 weeks after delivery

Measure: foetus with structural anomalies

Time: 6-8 weeks after delivery

Measure: side effects of dalteparin therapy (e.g. thrombocytopenia, osteoporosis, haemorrhage)

Time: 6-8 weeks after delivery

Measure: life birth

Time: 6-8 weeks after delivery

Measure: preterm delivery (< 37 weeks of gestation)

Time: 6-8 weeks after delivery

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 G20210A

Likewise, other thrombophilic risk factors including factor II G20210A, hyperhomocysteinemia, protein C, protein S and antithrombin deficiencies have also been associated with RPL (Sanson 1996; Brenner 1999). --- G20210A ---



HPO Nodes