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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02118038
First received: March 27, 2014
Last updated: January 10, 2017
Last verified: January 2017
History of Changes
March 27, 2014
January 10, 2017
November 2014
December 2016   (Final data collection date for primary outcome measure)
  • 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)
  • 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)
  • 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)
  • 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)
Same as current
Complete list of historical versions of study NCT02118038 on ClinicalTrials.gov Archive Site
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Emotional and Cardiac Impact of Postpartum Haemorrhage
Emotional and Cardiac Impact of Postpartum Haemorrhage. Observational Study HELP-MOM.
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
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Serum and plasma
Non-Probability Sample
Patients with postpartum hemorrhage
Postpartum Hemorrhage Treated With Sulprostone
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
329
December 2021
December 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT02118038
P111013
2013-A01062-43 ( Other Identifier: IDRCB )
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Chair: Etienne GAYAT, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Alexandre MEBAZAA, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
January 2017

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