Low Weight Heparin prOphylaxis for Placental‐Mediated Complications of PrEgnancy (HOPPE)

This study is currently recruiting participants.

Verified March 2012 by Hospital Universitari Vall d'Hebron Research Institute

Sponsor:

Collaborators:

Hospital Vall d'Hebron

Hospital Sant Joan de Deu

Hospital de Cruces

Parc Sanitari Sant Joan de Déu

Information provided by (Responsible Party):

Hospital Universitari Vall d'Hebron Research Institute

ClinicalTrials.gov Identifier:

NCT01388322

First received: June 28, 2011

Last updated: March 16, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 28, 2011

Last Updated Date

March 16, 2012

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Development of any of these complications of placental insufficiency [ Time Frame: from date of randomization until the date of delivery (assessed up to 30 weeks) ] [ Designated as safety issue: No ]

Development of any of these complications of placental insufficiency: preeclampsia, intrauterine growth restriction, abruption placentae, and/or intrauterine fetal demise

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01388322 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Gestational age at birth [ Time Frame: from date of randomization until the date of delivery (assessed up to 30 weeks) ] [ Designated as safety issue: No ]
Gestational age at birth
Days of hospitalization during pregnancy [ Time Frame: from randomization to the time of delivery (30 weeks) ] [ Designated as safety issue: No ]
Days of hospitalization during pregnancy
Days of maternal hospitalization in the postpartum period [ Time Frame: from delivery until discharge (an expected average of one week) ] [ Designated as safety issue: No ]
Days of maternal hospitalization in the postpartum period
Neonatal Data [ Time Frame: after the delivery (an expected average of one month) ] [ Designated as safety issue: No ]
weight, height, head circumference, Apgar score 1‐5 min, arterial pH, venous base excess (BE) of umbilical cord gases, and complications

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Low Weight Heparin prOphylaxis for Placental‐Mediated Complications of PrEgnancy

Official Title ^ICMJE

Enoxaparin for the Prevention of Placental‐Mediated Complications of Pregnancy in Women With Obstetric History or Abnormal Uterine Artery Doppler at First Trimester Ultrasound and Without Thrombophilia: a Multicenter Randomized Controlled Trial

Brief Summary

This is a Multicenter, randomized, open‐label, parallel groups study to test the hypothesis that prophylactic low molecular weight heparin (LMWH) (enoxaparin) initiated before 14 weeks of gestation could improve maternal and perinatal outcome in women at high risk for developing placental‐mediated pregnancy complications.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

High Risk Pregnant Women
Placental Insufficiency
Preeclampsia

Intervention ^ICMJE

Drug: Enoxaparin

40 mg (4000 IU) women <80 kg at the time of randomization or 60 mg (6000 IU) women> 80 kg at the time of randomization One dose daily. Subcutaneous administration. Treatment periods: the same day of the Initiation visit (from 9 to 13.6 weeks of gestation) until 36 weeks gestation.

Study Arm (s)

Experimental: Enoxaparin
Subcutaneous administration of one dose daily of enoxaparin

Intervention: Drug: Enoxaparin
No Intervention: expectant management
Usual management

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

361

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Pregnant women ≥18 years
Gestational age < 14 weeks at randomisation
One or more of the following complications in a previous pregnancy:
- Severe PE resulting in delivery before 32 weeks of gestation
- Newborn weight less than the 10th percentile and documented abnormal Doppler in the umbilical artery during pregnancy before 32 weeks gestation
- Abruption of placenta
- Unexplained intrauterine death between 20‐41,6 weeks of gestation secondary of placental insufficiency or
Uterine arteries Pulsatility Index (mPI) Doppler ≥95th percentile at 11‐14 weeks of gestation.

Exclusion Criteria:

Multiple pregnancy
Abnormal thrombophilia study
Alcohol or illicit drug use
Severe fetal malformations or chromosomal abnormalities
Previous history of infertility ( 3 or more early miscarriages)
Maternal HIV, Cytomegalovirus or toxoplasma infection
Known fetal abnormality or chromosomal defect at randomisation
Women with previous venous or arterial thrombotic event
Organic lesions that could increase the hemorrhagic risk: gastric ulcus, stroke, a recent hemorrhagic event, high risk situations for hemorrhagic event
Known allergy to heparin or LMWH, thrombopenia or thrombosis episode due to heparin treatment
Contraindication to LMWH
An absolute indication for anticoagulant therapy: venous deep thrombosis, pulmonary embolism, ovaric hyperestimulation, cardiophaty, others
Metabolic disorders a risk for development of PE and/or IUGR: Type I diabetes, hipertiroidism, chronic renal insufficiency

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Elisa Llurba, MD	34934893085	elluba@vhebron.net
Contact: Inmaculada Fuentes, MD	0034934894113 ext 4881	inma.fuentes@vhir.org

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01388322

Other Study ID Numbers ^ICMJE

HOPPE‐Trial, 2010‐023597‐39

Has Data Monitoring Committee

Responsible Party

Hospital Universitari Vall d'Hebron Research Institute

Study Sponsor ^ICMJE

Hospital Universitari Vall d'Hebron Research Institute

Collaborators ^ICMJE

Hospital Vall d'Hebron
Hospital Sant Joan de Deu
Hospital de Cruces
Parc Sanitari Sant Joan de Déu

Investigators ^ICMJE

Study Chair:	Lluís Cabero, MD PhD	Hospital Vall d'Hebron
Principal Investigator:	Elisa Llurba, MD	Hospital Vall d'Hebron
Principal Investigator:	Maria Dolores Gómez, MD	Hospital Sant Joan de Deu
Principal Investigator:	Txantón Martínez-Astorquiza, MD	Hospital de Cruces
Principal Investigator:	Raul De Diego, M.D.	Parc Sanitari Sant Joan de Deu

Information Provided By

Hospital Universitari Vall d'Hebron Research Institute

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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