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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

Tracking Information
First Submitted Date March 27, 2014
First Posted Date April 21, 2014
Last Update Posted Date January 11, 2017
Study Start Date November 2014
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2014)
  • 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)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02118038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Emotional and Cardiac Impact of Postpartum Haemorrhage
Official Title Emotional and Cardiac Impact of Postpartum Haemorrhage. Observational Study HELP-MOM.
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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum and plasma
Sampling Method Non-Probability Sample
Study Population Patients with postpartum hemorrhage
Condition Postpartum Hemorrhage Treated With Sulprostone
Intervention Not Provided
Study Groups/Cohorts
  • 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
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 Active, not recruiting
Actual Enrollment
 (submitted: January 10, 2017)
329
Original Estimated Enrollment
 (submitted: April 16, 2014)
800
Estimated Study Completion Date December 2021
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02118038
Other Study ID Numbers P111013
2013-A01062-43 ( Other Identifier: IDRCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Study Chair: Etienne GAYAT, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Alexandre MEBAZAA, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date January 2017