CClinicalTrials.gg
Status unknownNCT00573118Updated Dec 13, 2007

Severe Pregnancy Complications Are Associated With Elevated Factor VIII Plasma Activity

An observational study in Pregnancy Complications, Preeclampsia and Placental Abruption, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2007-12-13.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

The sponsor has not verified this record recently (last verified Dec 2007), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
100
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Congenital and acquired thrombophilia were identified as risk factors for thrombosis in systemic vessels.Thrombophilias have also been recently found to be associated with preeclampsia, intrauterine fetal growth restriction (IUGR), placental abruption, intrauterine fetal death (IUFD) and repeated pregnancy loss.These severe pregnancy complications are thought to result from thrombotic events occurring in the uteroplacental circulation. Accumulating data have established an association between elevated plasma activity of factor VIII and thrombosis although the mechanism is still not defined and elevated factor VIII activity is now regarded as being equivalent to thrombophilia.

We intend to investigatthe association between factor VIII levels and severe pregnancy complications which are considered to result from placental vascular pathology, i.e., preeclampsia, IUGR, placental abruption and IUFD. We hypothezise that the prevalence of elevated factor 8 will be higher among women with pregnancy complications compared to controls.

02

Conditions studied

  • Pregnancy Complications
  • Preeclampsia
  • Placental Abruption
  • Intrauterine Fetal Growth Restriction
  • Intrauterine Fetal Death

Keywords

  • Pregnancy complications: preeclampsia , severe IUGR , IUFD or placental abruption (n = 5).
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

women who had either normal pregnancy or complicated pregnancy

Inclusion criteria

  • Women who had either normal pregnancy or complicated pregnancy.

Exclusion criteria

Exclusion Criteria:

  • Other causes of pregnancy complication such as infections, anomalies and fetal malformations
04

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
100 participants (estimated)

Groups and cohorts

  • 1

    The study group included 49 patients with a previous history of one or more of the following pregnancy complications: preeclampsia (n = 17), severe IUGR (n = 13), IUFD (n = 14) or placental abruption (n = 5).

  • 2

    The control group included 49 healthy women who delivered during the study period, who did not smoke during pregnancy and in whom pregnancy and delivery were uneventful

05

What researchers measure

Primary outcomes

  1. prevalenc of elevated factor VIII

    Time frame: RETROSPECTIVE

06

Study locations

1 site
  • Tel Avis sourasky medical center
    Tel Aviv, 64239, Israel
07

Registry details

Key details

Study ID
NCT00573118
Lead sponsor
Tel-Aviv Sourasky Medical Center
First posted
Dec 13, 2007
Start date
Jan 2000
Completion
Jan 2008 (estimated)
Last update
Dec 13, 2007

Study contacts

Eli Rimon, MD
principal investigator · Tel Aviv medical center,Israel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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