Please select the eligibility criteria that correspond to the clinical trial below.
Title: Dose Adjusting Enoxaparin Thromboprophylaxis Dosage According to Anti-factor Xa Plasma Levels Improve Pregnancy Outcome
Brief Summary: The risk of venous thromboembolism increases in pregnancy. Thrombophilia whether genetic or acquired, is a hypercoagulable disorder that may increase the risk of venous thromboembolic events. Clinically, these events are presented as maternal deep vein thrombosis and pulmonary emboli. Thrombophilias are also associated with adverse fetal outcomes including intrauterine growth restriction, intrauterine fetal death, severe preeclampsia, placental abruption and recurrent abortions.

Pregnant women who experienced one or more of the above complications are advised to be examined for the presence of the genetic or the acquired form of thrombophilia.

Low molecular weight heparin prophylaxis, an anticoagulant, is advised for pregnant women with a history of thromboembolism, and many experts recommend prophylaxis for pregnant patients with a known thrombophilia and history of adverse pregnancy outcomes associated with these hypercoagulable states.

Physiologic changes in normal pregnancy, including weight gain, increased renal clearance and volume of distribution, may decrease the availability of low molecular weight heparin (Enoxaparin or Dalteparin), or produce a less predictable response in pregnant women compared with nonpregnant women. There are no clear recommendations for use of prophylactic low molecular weight heparin in pregnancy. Clinicians tend to use doses suggested for nonpregnant patients. Regarding pregnant patients taking enoxaparin or dalteparin, the American College of Obstetricians and Gynecologists states that "because of the lack of data regarding adequate dosing during pregnancy, anti-factor Xa levels may be monitored".

Two recently published studies demonstrated that plasma anti-factor Xa levels during pregnancy were lower than expected, indicating that many pregnant patients may receive a subprophylactic dosing.

Our objective is to check pregnancy outcome among thrombophilic women treated with an adjusted enoxaparin thromboprophylaxis dosage according to anti-factor Xa plasma levels compared to women with fixed dosage.


Options:
A: Inclusion Criteria:

* Confirmed pregnancy;
* 18 years or older;
* Two or more unexplained pregnancy loss before the 10th week of gestation, AND/OR one or more unexplained pregnancy loss at or beyond the 10th week of gestation;
* One or more APS laboratory criteria present, according to the revised Sapporo criteria;

Exclusion Criteria:

* Greater than 11 weeks +6 days gestational age at time of randomization;
* Indication(s) for prophylactic or therapeutic-dose anticoagulation;
* Contraindication to heparin or aspirin;
* Received 7 or more doses of LMWH;
* Previous participation in the trial;
* Geographic inaccessibility;
* Refused consent.
B: Inclusion Criteria:

* Patients following cesarean delivery
* Consent to participation
* No medical recommendation for bed rest and limited mobility
* Meet any of the following criteria for high risk for thromboembolic complications - preeclampsia, chronic disease (reumatic, inflammatory bowel disease), obese, smoker \> 10 cigaretts a day, age \>35, substantial limb varicose, multiple gestation, multiparity (\> deliveries), emergent surgery, thrombophilia.

Exclusion Criteria:

* Refusal to participate
* Medical recommendation to limit mobility
C: Inclusion Criteria:

WOMEN WITH

* Singleton gestation
* A history of fetal demise, fetal growth restriction, placental abruption, preeclampsia, recurrent abortions or maternal thromboembolic event.
* Acquired or congenital thrombophilia treated with low molecular weight heparin

Exclusion Criteria:

* Women treated empirically with low molecular weight heparin
* Women with a history of pregestational diabetes.
* Significant polyhydramnios or oligohydramnios, major fetal structural, generic or chromosomal malformations
D: Inclusion Criteria:

* Women with a body mass index \>35 who have undergone cesarean delivery in the last 12 hours who will receive thromboprophylaxis with enoxaparin
* Subjects who consent to the study.

Exclusion Criteria:

* Women with a previous history of deep venous thrombosis or pulmonary embolism
* Women who are currently receiving another form of low molecular weight heparin or unfractionated heparin.
* Women who are receiving other concomitant anticoagulant medications, such as warfarin, lepirudin, or argatroban.
* Subjects who are unable or unwilling to give informed consent.
* Women who, in the judgment of the investigators, would not be in the best interest of the patient to participate in the study.
* Allergy to enoxaparin.
* Women with renal impairment
* Women with contraindications to Lovenox treatment such as women with active bleeding or thrombocytopenia

Answer: C