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

NCT07885072 — Recruiting, 380 participants, University of Zurich

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Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage at a Single Tertiary Center

RegistryNCT07885072, acronym LOVIT
StatusRecruiting
Study typeObservational
Enrollment380 (Estimated)
SponsorUniversity of Zurich (Other)
ConditionsPostpartum Hemorrhage, Treatment Outcome, Pregnancy Outcome
Datesstart 2026-10-01, primary completion 2027-10-01 (estimated), completion 2027-10-01 (estimated), first posted 2026-10-21, last updated 2026-10-21
Locations1 site in Switzerland

Related Papers Related Patents Related Grants Related Experts
All trials for Postpartum Hemorrhage All trials for Treatment Outcome

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Women to have received vacuum induced tamponade during 2017-2025

+Outcome measures

Primary outcomes

  • Occurrence of secondary infertility [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.

Secondary outcomes

  • Pregnancy outcomes [January 2017 until December 2025]: Pregnancy outcomes, including pregnancy complications and live birth rates
  • Time to conception [January 2017 until December 2025]: Time to conception for * the index pregnancy (i.e. the pregnancy during which VIT was applied), and * the first subsequent pregnancy after VIT
  • Patient-reported fertility difficulties [January 2017 until December 2025]: Patient-reported fertility difficulties, including duration of attempts to conceive and the need for assisted reproductive technologies
  • Fertility-related complications [January 2017 until December 2025]: Fertility-related complications, such as intrauterine adhesions
  • Psychological outcomes [January 2017 until December 2025]: 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.

+Eligibility

Sex: Female, ages: 18 Years to any

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:

* 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).

+Locations (1)

FacilityCityCountryStatus
University Hospital Zurich, Department of ObstetricsZurich, Canton of ZurichSwitzerlandRecruiting

+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. PMID 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. PMID 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. PMID 32909970