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Emotional and Cardiac Impact of Postpartum Haemorrhage (HELP-MOM)

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ClinicalTrials.gov Identifier: NCT02118038
Recruitment Status : Active, not recruiting
First Posted : April 21, 2014
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
To assess the impact and to identify the main risk factors for psychological and cardiac morbidity (post-traumatic stress disorder, anxiety and depression) in case of postpartum hemorrhage

Condition or disease
Postpartum Hemorrhage Treated With Sulprostone

Detailed Description:
The HELP- MOM study is an observational study that seeks to identify the major determinants of morbidity induced by postpartum hemorrhage (PPH) in the short and medium term. Even if PPH remains the leading cause of death in the world and in France , its main impact in so-called developed countries is not so much maternal mortality ( which is very small ) but induced morbidity.Data from the literature suggest that in a number of cases, PPH is associated with cardiac abnormalities. The nature of the abnormalities, their potential impact on the functioning of the cardiovascular system of women and their evolution over time (possibility of persistent sequelae) are not known. Similarly, it is known that the postpartum period of normal pregnancy followed by a normal delivery is at risk of psychological disorders in the mother. The PPH is a very serious situation where sometimes the vital prognosis of the mother was committed. Again, determining the exact nature and consequences of psychological harm secondary PPH are not known. Finally, fertility and the risk of recurrence after an episode PPH are also poorly understood. Outside hysterectomy hemostasis which permanently affects the fertility of the patient, the severity and type of management of PPH most likely affect fertility. Only a long-term monitoring could help address this issue. Thus, HELP MOM - study aims to address these issues. To do this, HELP MOM, was divided into two sub- studies : 1) HELP-MOM 1 "multidisciplinaire" which corresponds to the cohort of patients in whom psychological state will be studied in the immediate waning PPH then during a 6 months through appropriate questionnaires , 2 ) HELP-MOM 2 "cardio" that corresponds to the cohort of patients who experienced a cardiac abnormality in the initial management and will therefore be included in a cardiac monitoring.

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Study Type : Observational
Actual Enrollment : 329 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Emotional and Cardiac Impact of Postpartum Haemorrhage. Observational Study HELP-MOM.
Study Start Date : November 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort
HELPMOM1
corresponds to the cohort of patients in whom psychological state will be studied in the immediate waning PPH then during a 6 months through appropriate questionnaires
HELPMOM2
corresponds to the cohort of patients enrolled in group HELPMOM1 who experienced a cardiac abnormality in the initial management and will therefore be included in a cardiac monitoring



Primary Outcome Measures :
  1. Identification of risk factors for psychological impact of PPH [ Time Frame: 1 month ]
    Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)

  2. Occurrence of a cardiac event [ Time Frame: Day0 ]
    Occurrence of a cardiac event, defined as an elevation of troponin or BNP or an EKG modification during the acute phase of postpartum hemorrhage (PPH) (HELPMOM2)

  3. Identification of risk factors for psychological impact of PPH [ Time Frame: 3 months ]
    Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)

  4. Identification of risk factors for psychological impact of PPH [ Time Frame: 6 months ]
    Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)


Biospecimen Retention:   Samples Without DNA
Serum and plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with postpartum hemorrhage
Criteria

Inclusion Criteria:

HELPMOM1 :

  • Patients with postpartum hemorrhage and receiving sulprostone
  • Patient affiliated with social security

HELPMOM2 :

  • Enrolled HELMOM1
  • Presence of one or more items from the following list at the moment of PPH:

    • elevated troponin ("classical" or ultra) exceeds 5 times the normal value (about> 0.20 g / ml depending on the laboratory) and / or
    • electrocardiographic abnormalities (ST-segment abnormalities and / or T wave abnormalities searched in all 12 leads) and / or
    • rate of BNP (Brain Natriuretic Peptide) greater than 100 pg / m

Exclusion Criteria:

HELPMOM1:

  • Age < 18 years
  • Hemorrhage caused by a miscarriage, a clandestine abortion, fetal death in utero or medical or voluntary termination of pregnancy.

HELPMOM2:

- Patient with pace maker


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02118038


Locations
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France
Département Anesthésie et Réanimation - Hôpital Lariboisière
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Study Chair: Etienne GAYAT, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Alexandre MEBAZAA, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02118038     History of Changes
Other Study ID Numbers: P111013
2013-A01062-43 ( Other Identifier: IDRCB )
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Postpartum haemorrhage
Sulprostone
Cardiac impact
Emotional impact
Cardiac magnetic imaging resonance

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage