Postpartum HemorrhageLOVITNCT07885072
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
An observational study of Postpartum Hemorrhage and Treatment Outcome, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study will investigate all women treated with vacuum-induced tamponade (VIT) for PPH at a tertiary center, namely at the University Hospital Zurich (USZ), over a nine-year period (2017-2025). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Hemorrhage, Treatment Outcome, Pregnancy Outcome
- How many people
- 380 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Women who gave birth between January 2017 and December 2025
Who may be able to join
- Women ≥ 18 years of age.
- Delivery at the USZ between January 2017 and December 2025. Documented postpartum hemorrhage managed with VIT.
- Provision of written informed consent
Who cannot join
- Decline of informed consent.
- Inability to establish contact (e.g., incorrect address, telephone number not reachable, moved abroad).
- Women who are unable to provide informed consent (e.g., due to language barriers without translation support, or cognitive impairment).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Department of Obstetrics
Zurich, Canton of Zurich, 8091
Stylianos Kalimeris, Dr. med., +41 43 253 17 08, stylianos.kalimeris@usz.ch
Christian Haslinger, Prof. Dr. med., +41 43 253 75 75, christian.haslinger@usz.ch
About this study
Official title: Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage at a Single Tertiary Center
This study will investigate all women treated with vacuum-induced tamponade (VIT) for PPH at a tertiary center, namely at the University Hospital Zurich (USZ), over a nine-year period (2017-2025). By combining hospital data with follow-up patient questionnaires, it will provide new information on reproductive outcomes and contribute to the evaluation of the long-term safety profile of vacuum-induced tamponade.
Read the detailed description
Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. When first-line medical treatments fail, uterine tamponade is an established second-line intervention. Vacuum-induced tamponade is a relatively new method that offers rapid uterine collapse and bleeding control, and has shown good short-term effectiveness.
Long-term outcomes following vacuum-induced tamponade have not been studied. Specifically, to our knowledge no data exists on its impact on fertility, subsequent pregnancies, or potential complications such as intrauterine adhesions.
Since most women affected by PPH are of reproductive age, this information is highly relevant for clinical care and patient counseling for the following family plan.
This study will investigate all women treated with vacuum-induced tamponade (VIT) for PPH at a tertiary center, namely at the University Hospital Zurich (USZ), over a nine-year period. By combining hospital data with follow-up patient questionnaires, it will provide new information on reproductive outcomes and contribute to the evaluation of the long-term safety profile of vacuum-induced tamponade.
The results may help to guide future clinical decisions, improve patient information, and contribute to the broader evaluation of long-term effects of vacuum-induced tamponade in obstetric practice.
The objective of this project is to descriptively assess the occurrence of secondary infertility in women who underwent vacuum-induced tamponade for postpartum hemorrhage at the University Hospital of Zurich between January 2017 until December 2025.
As long-term reproductive outcomes after VIT have not previously been systematically investigated, this study is primarily exploratory and hypothesis-generating.
The findings will provide preliminary estimates of fertility-related outcomes, including secondary infertility and time to conception, and will serve as a basis for the design, sample size calculation, and feasibility assessment of future prospective studies.
- Conditions
- Postpartum Hemorrhage, Treatment Outcome, Pregnancy Outcome
- Keywords
- postpartum hemorrhage (PPH), vacuum-induced tamponade (VIT), Treatment Outcome, Pregnancy Outcome
- 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 |
|---|---|---|
| Women to have received vacuum induced tamponade during 2017-2025 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of secondary infertility
The primary objective of this project is to descriptively assess the occurrence of secondary infertility in women who underwent vacuum-induced tamponade for postpartum hemorrhage at the University Hospital of Zurich.
Measured: January 2017 until December 2025
Secondary outcomes (5)
Pregnancy outcomes
Pregnancy outcomes, including pregnancy complications and live birth rates
Measured: January 2017 until December 2025
Time to conception
Time to conception for
- the index pregnancy (i.e. the pregnancy during which VIT was applied), and
- the first subsequent pregnancy after VIT
Measured: January 2017 until December 2025
Patient-reported fertility difficulties
Patient-reported fertility difficulties, including duration of attempts to conceive and the need for assisted reproductive technologies
Measured: January 2017 until December 2025
Fertility-related complications
Fertility-related complications, such as intrauterine adhesions
Measured: January 2017 until December 2025
Psychological outcomes
Psychological outcomes before and after childbirth in women with VIT, including the type of reported psychological problems and the use of medication for mental health conditions.
Measured: January 2017 until December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Oct 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Retrospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Haslinger, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885072
- Sponsor's protocol ID
- 2026-00768
- Acronym
- LOVIT
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fullerton G, Danielian PJ, Bhattacharya S. Outcomes of pregnancy following postpartum haemorrhage. BJOG. 2013 Apr;120(5):621-7. doi: 10.1111/1471-0528.12120. Epub 2013 Jan 23.
PubMed 23339709Haslinger C, Weber K, Zimmermann R. Vacuum-Induced Tamponade for Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2021 Sep 1;138(3):361-365. doi: 10.1097/AOG.0000000000004510.
PubMed 34352848D'Alton ME, Rood KM, Smid MC, Simhan HN, Skupski DW, Subramaniam A, Gibson KS, Rosen T, Clark SM, Dudley D, Iqbal SN, Paglia MJ, Duzyj CM, Chien EK, Gibbins KJ, Wine KD, Bentum NAA, Kominiarek MA, Tuuli MG, Goffman D. Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2020 Nov;136(5):882-891. doi: 10.1097/AOG.0000000000004138.
PubMed 32909970
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage at a Single Tertiary Center
- ClinicalTrials.gov ID
- NCT07885072
- Acronym / sponsor ID
- LOVIT / 2026-00768
- Conditions
- Postpartum Hemorrhage, Treatment Outcome, Pregnancy Outcome
- Keywords
- postpartum hemorrhage (PPH), vacuum-induced tamponade (VIT), Treatment Outcome, Pregnancy Outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 21 Oct 2026 (actual)
- 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.
This study will investigate all women treated with vacuum-induced tamponade (VIT) for PPH at a tertiary center, namely at the University Hospital Zurich (USZ), over a nine-year period (2017-2025). By combining hospital data with follow-up patient questionnaires, it will provide new information on reproductive outcomes and contribute to the evaluation of the long-term safety profile of vacuum-induced tamponade.
Detailed description
Postpartum hemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. When first-line medical treatments fail, uterine tamponade is an established second-line intervention. Vacuum-induced tamponade is a relatively new method that offers rapid uterine collapse and bleeding control, and has shown good short-term effectiveness.
Long-term outcomes following vacuum-induced tamponade have not been studied. Specifically, to our knowledge no data exists on its impact on fertility, subsequent pregnancies, or potential complications such as intrauterine adhesions.
Since most women affected by PPH are of reproductive age, this information is highly relevant for clinical care and patient counseling for the following family plan.
This study will investigate all women treated with vacuum-induced tamponade (VIT) for PPH at a tertiary center, namely at the University Hospital Zurich (USZ), over a nine-year period. By combining hospital data with follow-up patient questionnaires, it will provide new information on reproductive outcomes and contribute to the evaluation of the long-term safety profile of vacuum-induced tamponade.
The results may help to guide future clinical decisions, improve patient information, and contribute to the broader evaluation of long-term effects of vacuum-induced tamponade in obstetric practice.
The objective of this project is to descriptively assess the occurrence of secondary infertility in women who underwent vacuum-induced tamponade for postpartum hemorrhage at the University Hospital of Zurich between January 2017 until December 2025.
As long-term reproductive outcomes after VIT have not previously been systematically investigated, this study is primarily exploratory and hypothesis-generating.
The findings will provide preliminary estimates of fertility-related outcomes, including secondary infertility and time to conception, and will serve as a basis for the design, sample size calculation, and feasibility assessment of future prospective studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women to have received vacuum induced tamponade during 2017-2025 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women who gave birth between January 2017 and December 2025
Key inclusion criteria (3 listed)
- Women ≥ 18 years of age.
- Delivery at the USZ between January 2017 and December 2025. Documented postpartum hemorrhage managed with VIT.
- Provision of written informed consent
Key exclusion criteria (3 listed)
- Decline of informed consent.
- Inability to establish contact (e.g., incorrect address, telephone number not reachable, moved abroad).
- Women who are unable to provide informed consent (e.g., due to language barriers without translation support, or cognitive impairment).
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
Occurrence of secondary infertility
Time frame: January 2017 until December 2025
The primary objective of this project is to descriptively assess the occurrence of secondary infertility in women who underwent vacuum-induced tamponade for postpartum hemorrhage at the University Hospital of Zurich.
5 secondary outcomes
Pregnancy outcomes
Time frame: January 2017 until December 2025
Time to conception
Time frame: January 2017 until December 2025
Patient-reported fertility difficulties
Time frame: January 2017 until December 2025
Fertility-related complications
Time frame: January 2017 until December 2025
Psychological outcomes
Time frame: January 2017 until December 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 23339709Fullerton G, Danielian PJ, Bhattacharya S. Outcomes of pregnancy following postpartum haemorrhage. BJOG. 2013 Apr;120(5):621-7. doi: 10.1111/1471-0528.12120. Epub 2013 Jan 23.
- Background: PubMed 34352848Haslinger C, Weber K, Zimmermann R. Vacuum-Induced Tamponade for Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2021 Sep 1;138(3):361-365. doi: 10.1097/AOG.0000000000004510.
- Background: PubMed 32909970D'Alton ME, Rood KM, Smid MC, Simhan HN, Skupski DW, Subramaniam A, Gibson KS, Rosen T, Clark SM, Dudley D, Iqbal SN, Paglia MJ, Duzyj CM, Chien EK, Gibbins KJ, Wine KD, Bentum NAA, Kominiarek MA, Tuuli MG, Goffman D. Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage. Obstet Gynecol. 2020 Nov;136(5):882-891. doi: 10.1097/AOG.0000000000004138.
- Individual participant dataSharing planned: Undecided
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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.
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 and Treatment Outcome, run by University of Zurich at 1 site in Switzerland.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Haslinger, Prof. Dr (+41432537575, christian.haslinger@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of secondary infertility (time frame: January 2017 until December 2025). 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 NCT07885072, which also lists 3 linked publications.
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 21 Oct 2026.