Emotional and Cardiac Impact of Postpartum Haemorrhage

Completed

• Conditions: Postpartum Hemorrhage Treated With Sulprostone

• Registration Number: NCT02118038
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Study Start: 2014-11-21
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 329

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of risk factors for psychological impact of PPH	6 months	Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)
Occurrence of a cardiac event	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)

Trial Locations

Locations (1)

Département Anesthésie et Réanimation - Hôpital Lariboisière; 🇫🇷 Paris, France