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Emotional and Cardiac Impact of Postpartum Haemorrhage

Emotional and Cardiac Impact of Postpartum Haemorrhage. Observational Study HELP-MOM.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02118038
Acronym
HELP-MOM
Enrollment
329
Registered
2014-04-21
Start date
2014-11-21
Completion date
2019-04-30
Last updated
2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Hemorrhage Treated With Sulprostone

Keywords

Postpartum haemorrhage, Sulprostone, Cardiac impact, Emotional impact, Cardiac magnetic imaging resonance

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.

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Identification of risk factors for psychological impact of PPH1 monthIdentification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)
Occurrence of a cardiac eventDay0Occurrence 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)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026