- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02118038
Emotional and Cardiac Impact of Postpartum Haemorrhage (HELP-MOM)
July 23, 2019 updated by: Assistance Publique - Hôpitaux de Paris
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
Study Overview
Status
Completed
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
Enrollment (Actual)
329
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France, 75010
- Département Anesthésie et Réanimation - Hôpital Lariboisière
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients with postpartum hemorrhage
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
1 month
|
Occurrence of a cardiac event
Time Frame: Day0
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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)
|
Day0
|
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)
|
3 months
|
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)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alexandre MEBAZAA, MD, PhD, Assistance Publique - Hôpitaux de Paris
- Study Chair: Etienne GAYAT, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 21, 2014
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
March 27, 2014
First Submitted That Met QC Criteria
April 16, 2014
First Posted (Estimate)
April 21, 2014
Study Record Updates
Last Update Posted (Actual)
July 24, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P111013
- 2013-A01062-43 (Other Identifier: IDRCB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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