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

NCT07885072 | Recruiting

• 1 other identifier: 2026-00768
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Hemorrhage; Treatment Outcome; Pregnancy Outcome

Keywords

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

Outcome Measures

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.

  January 2017 until December 2025

Secondary Outcomes (5)

• Pregnancy outcomes

  January 2017 until December 2025

• Time to conception

  January 2017 until December 2025

• Patient-reported fertility difficulties

  January 2017 until December 2025

• Fertility-related complications

  January 2017 until December 2025

• Psychological outcomes

  January 2017 until December 2025

Study Arms (1)

Women to have received vacuum induced tamponade during 2017-2025

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who gave birth between January 2017 and December 2025
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who gave birth between January 2017 and December 2025

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Department of Obstetrics

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christian Haslinger, Prof. Dr

CONTACT

+41432537575; christian.haslinger@usz.ch

Stylianos Kalimeris, Dr. med.

CONTACT

+41 43 253 17 08; stylianos.kalimeris@usz.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

CH (1)