Emotional and Cardiac Impact of Postpartum Haemorrhage

Postpartum Hemorrhage Treated With Sulprostone Clinical Trial

— HELP-MOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118038
• Other study ID #: P111013
• Secondary ID: 2013-A01062-43
• Status: Completed
• Start date: November 21, 2014
• Est. completion date: April 2019

Study information

• Verified date: July 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Postpartum Hemorrhage Treated With Sulprostone

Locations

Country	Name	City	State
France	Département Anesthésie et Réanimation - Hôpital Lariboisière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of risk factors for psychological impact of PPH	Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)	1 month
Primary	Occurrence of a cardiac event	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
Primary	Identification of risk factors for psychological impact of PPH	Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)	3 months
Primary	Identification of risk factors for psychological impact of PPH	Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)	6 months