Postpartum Hemorrhage Treated With SulprostoneHELP-MOMNCT02118038
Emotional and Cardiac Impact of Postpartum Haemorrhage
An observational study of Postpartum Hemorrhage Treated With Sulprostone, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage Treated With Sulprostone
- How many people
- 329 participants
- Where
- 1 siteFrance
- Study dates
- 21 Nov 2014to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with postpartum hemorrhage
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Département Anesthésie et Réanimation - Hôpital Lariboisière
Paris, 75010
About this study
Official title: 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
Read the 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.
- Keywords
- Postpartum haemorrhage, Sulprostone, Cardiac impact, Emotional impact, Cardiac magnetic imaging resonance
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Identification of risk factors for psychological impact of PPH
Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)
Measured: 1 month
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)
Measured: Day0
Identification of risk factors for psychological impact of PPH
Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)
Measured: 3 months
Identification of risk factors for psychological impact of PPH
Identification of risk factors for psychological impact of PPH, as measured three questionnaires (HELPMOM1)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study start21 Nov 2014
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Hemorrhage Treated With SulprostoneStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne GAYAT, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisAlexandre MEBAZAA, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118038
- Sponsor's protocol ID
- P111013
- Other IDs
- 2013-A01062-43
- Acronym
- HELP-MOM
- Status last verified
- Jul 2019
- First submitted
- 27 Mar 2014
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Deniau B, Ricbourg A, Weiss E, Paugam-Burtz C, Bonnet MP, Goffinet F, Mignon A, Morel O, Le Guen M, Binczak M, Carbonnel M, Michelet D, Dahmani S, Pili-Floury S, Ducloy Bouthors AS, Mebazaa A, Gayat E. Association of severe postpartum hemorrhage and development of psychological disorders: Results from the prospective and multicentre HELP MOM study. Anaesth Crit Care Pain Med. 2024 Apr;43(2):101340. doi: 10.1016/j.accpm.2023.101340. Epub 2023 Dec 19.
PubMed 38128731
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional and Cardiac Impact of Postpartum Haemorrhage. Observational Study HELP-MOM.
- ClinicalTrials.gov ID
- NCT02118038
- Acronym / sponsor ID
- HELP-MOM / P111013
- Keywords
- Postpartum haemorrhage, Sulprostone, Cardiac impact, Emotional impact, Cardiac magnetic imaging resonance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 21 Nov 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with postpartum hemorrhage
Key inclusion criteria (9 listed)
- Patients with postpartum hemorrhage and receiving sulprostone
- Patient affiliated with social security
- Enrolled HELMOM1
- Presence of one or more items from the following list at the moment of PPH:
Key exclusion criteria (5 listed)
- Age < 18 years
- Hemorrhage caused by a miscarriage, a clandestine abortion, fetal death in utero or medical or voluntary termination of pregnancy.
- Patient with pace maker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Occurrence of a cardiac event
Time frame: 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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Derived from this study: PubMed 38128731Deniau B, Ricbourg A, Weiss E, Paugam-Burtz C, Bonnet MP, Goffinet F, Mignon A, Morel O, Le Guen M, Binczak M, Carbonnel M, Michelet D, Dahmani S, Pili-Floury S, Ducloy Bouthors AS, Mebazaa A, Gayat E. Association of severe postpartum hemorrhage and development of psychological disorders: Results from the prospective and multicentre HELP MOM study. Anaesth Crit Care Pain Med. 2024 Apr;43(2):101340. doi: 10.1016/j.accpm.2023.101340. Epub 2023 Dec 19.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne GAYAT, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
Alexandre MEBAZAA, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Hemorrhage Treated With Sulprostone, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of risk factors for psychological impact of PPH (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02118038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.