Emotional and Cardiac Impact of Postpartum Haemorrhage (HELP-MOM)
This study is ongoing, but not recruiting participants.
Sponsor:
Assistance Publique - Hôpitaux de Paris
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
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Purpose
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 |
|---|
| Postpartum Hemorrhage Treated With Sulprostone |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Emotional and Cardiac Impact of Postpartum Haemorrhage. Observational Study HELP-MOM. |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- 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)
Biospecimen Retention: Samples Without DNA
Serum and plasma
| Enrollment: | 329 |
| Study Start Date: | November 2014 |
| Estimated Study Completion Date: | December 2021 |
| Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02118038
Please refer to this study by its ClinicalTrials.gov identifier: NCT02118038
Locations
| France | |
| Département Anesthésie et Réanimation - Hôpital Lariboisière | |
| Paris, France, 75010 | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Study Chair: | Etienne GAYAT, MD, PhD | Assistance Publique - Hôpitaux de Paris |
| Principal Investigator: | Alexandre MEBAZAA, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
| 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 ) |
| Study First Received: | March 27, 2014 |
| Last Updated: | January 10, 2017 |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Postpartum haemorrhage Sulprostone Cardiac impact Emotional impact Cardiac magnetic imaging resonance |
Additional relevant MeSH terms:
|
Hemorrhage Postpartum Hemorrhage Pathologic Processes Obstetric Labor Complications |
Pregnancy Complications Puerperal Disorders Uterine Hemorrhage |
ClinicalTrials.gov processed this record on July 17, 2017


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