Anticoagulation Regimens in Pregnant Patients With Prosthetic Heart Valves

Not Applicable

• Conditions: Pregnancy; Heart; Complications, Valve, Prosthesis
• Interventions: Drug: Enoxaparine and 4mg Warfarin; Drug: Enoxaparine and 2.5 mg Warfarin; Drug: Warfarin

• Registration Number: NCT02240927
• Lead Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Brief Summary

Pregnancy is associated with increased risk of thrombosis among women with mechanical prosthetic heart valves.However, the best anticoagulant treatment strategies for pregnant patients with prosthetic heart valves have been controversial. In this study the investigators wanted to identify the most effective and safe regimen among different anticoagulant regimens.

Detailed Description

Four different anticoagulant treatment regimens for pregnant patients with prosthetic heart valves have been described. In the first arm warfarin is stopped and enoxaparine is started in 1mg/kg dose twice a day which is monitored by weekly anti-Xa levels (between 0.7-1.2) during the first trimester and followed by only warfarin after first trimester. In the second arm, if the patient's warfarin consumption is more than 5 mg before pregnancy, warfarin dose is decreased to 2.5 mg during the first trimester combined with enoxaparine in 1mg/kg dose twice a day; adjusted by measurements of anti-Xa levels (between 0.5-1) weekly until the end of 12th week of pregnancy . In the third arm warfarin dose is decreased to 4 mg during the first trimester combined with enoxaparine given in a similar manner. If the patient's therapeutic warfarin dose is less than 5 mg before pregnancy, warfarin is continued in the same dose during all the pregnancy in the 4th arm. All patients are followed by serial transesophageal echocardiography performed at 0,3,6 and 9. months of pregnancy. Informed consent is taken from all patients. After delivery the babies are examined by a experinced pediatrician and pediatric cardiologist for any congenital anomalies.

Study Timeline

• Study Start: 2010-01
• Status Verified: 2014-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-15
• Last Update Submitted: 2014-09-15
• Study First Posted: 2014-09-16
• Last Update Posted: 2014-09-16
• Primary Completion: 2015-06
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Pregnant patients with prosthetic heart valves

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enoxaparine and 4 mg warfarin	Enoxaparine and 4mg Warfarin	If the patient's warfarin consumption dose is more than 5 mg before pregnancy, warfarin dose is decreased to 4 mg during the first trimester and combined with enoxaparine in 1mg/kg dose twice a day. Enoxaparine dose is adjusted according to anti-factor Xa levels (between 0.5-1). Full dose warfarin is continued after first trimester and dose is regulated according to INR level (between 2.5-4).
Enoxaparine and 2.5 mg warfarin	Enoxaparine and 2.5 mg Warfarin	If the patient's therapeutic warfarin dose is more than 5 mg before pregnancy, warfarin dose is decreased to 2.5 mg during the first trimester and combined with enoxaparine in 1mg/kg dose twice a day. Enoxaparine dose is adjusted according to anti-factor Xa levels (between 0.5-1.0). Full dose warfarin is continued after first trimester and dose is regulated according to INR (between 2.5-4)
Warfarin	Warfarin	If the patient's therapeutic warfarin dose is less than 5 mg before pregnancy, warfarin is continued in the same dose during all the pregnancy and the dose is adjusted according to INR level (between 2.5-4).

Primary Outcome Measures

Name	Time	Method
Fetal Complications	12 months	Any congenital anomalia which may be attributed to warfarin or enoxaparine usage during pregnancy
Successful pregnancy	12 month	In the absence of fetal and maternal fatal or nonfatal major complications successful pregnancy
Maternal Complications	Participants will be followed during pregnancy and postpartum period, an expected average of 12 months	* Nonfatal major complication: Ischemic stroke, intracranial hemorrhage, embolism (coronary or peripheral), bleeding requiring transfusion, abortus, placental hemorrhage, Assessment of an increase in thrombus burden more than 50% and/or progression of PVT obstruction by transesophageal echocardiography.; * Nonfatal minor complication: Bleeding without need for transfusion, TIA.

Trial Locations

Locations (1)

Kosuyolu Kartal Heart Training and Research Hospital; 🇹🇷 Istanbul, Turkey