Clinical trial NCT02118038: Emotional and Cardiac Impact of Postpartum Haemorrhage
Official title: Emotional and Cardiac Impact of Postpartum Haemorrhage. Observational Study HELP-MOM.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Hemorrhage Treated With Sulprostone
Keywords: Postpartum haemorrhage
Sulprostone
Cardiac impact
Emotional impact
Cardiac magnetic imaging resonance
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 329
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with postpartum hemorrhage

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.

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

Primary outcomes:
measure: Identification of risk factors for psychological impact of PPH
timeFrame: 1 month
measure: Occurrence of a cardiac event
timeFrame: Day0
measure: Identification of risk factors for psychological impact of PPH
timeFrame: 3 months
measure: Identification of risk factors for psychological impact of PPH
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Département Anesthésie et Réanimation - Hôpital Lariboisière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Etienne GAYAT, MD, PhD
role: STUDY_CHAIR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alexandre MEBAZAA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: