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RecruitingNCT07885072LOVITUpdated Oct 21, 2026

Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage

An observational study in Postpartum Hemorrhage, Treatment Outcome and Pregnancy Outcome, sponsored by University of Zurich. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by University of Zurich · Observational

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
380
Ages
18 Years and older
Sex
Female
01

Study 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). 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.

02

Conditions studied

  • Postpartum Hemorrhage
  • Treatment Outcome
  • Pregnancy Outcome

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Keywords

  • postpartum hemorrhage (PPH)
  • vacuum-induced tamponade (VIT)
  • Treatment Outcome
  • Pregnancy Outcome
03

In context

Postpartum Hemorrhage

456 studies on the registry are indexed under Postpartum Hemorrhage; 77 are open to participants now.

This study's planned enrollment of 380 is above the median of 169 across 94 observational studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,048 studies on the registry; 131 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Women who gave birth between January 2017 and December 2025

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
380 participants (estimated)
Patient registry
No

Groups and cohorts

  • Women to have received vacuum induced tamponade during 2017-2025
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: January 2017 until December 2025

Secondary outcomes

  1. Pregnancy outcomes

    Pregnancy outcomes, including pregnancy complications and live birth rates

    Time frame: January 2017 until December 2025

  2. 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

    Time frame: January 2017 until December 2025

  3. Patient-reported fertility difficulties

    Patient-reported fertility difficulties, including duration of attempts to conceive and the need for assisted reproductive technologies

    Time frame: January 2017 until December 2025

  4. Fertility-related complications

    Fertility-related complications, such as intrauterine adhesions

    Time frame: January 2017 until December 2025

  5. 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.

    Time frame: January 2017 until December 2025

07

Study locations

1 of 1 sites recruiting
  • University Hospital Zurich, Department of Obstetrics
    Zurich, Canton of Zurich 8091, Switzerland
    Recruiting
08

References and documents

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 23339709 ↗
  • Haslinger 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 34352848 ↗
  • D'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 ↗

Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07885072
Responsible party
Christian Haslinger (Prof. Dr. med., University of Zurich) — Principal investigator
First posted
Oct 21, 2026
Start date
Oct 1, 2026
Primary completion
Oct 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Christian Haslinger, Prof. Dr
Contact
christian.haslinger@usz.ch
+41432537575
Stylianos Kalimeris, Dr. med.
Contact
stylianos.kalimeris@usz.ch
+41 43 253 17 08

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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