title: Prospective cohort study of a new vacuum delivery device to assist with complicated labour in low-resource settings.
abstract: OBJECTIVE
  Currently available vacuum devices used to assist women undergoing complicated labour are unsuitable for use in low-resource settings. The objective of this study was to evaluate the safety and feasibility of a new low-cost vacuum device, named Koohi Goth Vacuum Delivery System (KGVDS), designed for use in low-resource settings.
  
  
  METHODS
  A hospital-based, multicentre, prospective cohort study with no control group was conducted in Karachi, Pakistan. After training, KGVDS devices were made available for use by labour room staff at their discretion when instrumental delivery was indicated. Women to whom KGVDS was applied were followed from the start of labour until discharge. Feasibility was assessed in terms of successful expulsion of the foetal head following application of KGVDS and ease of use ratings. Safety was assessed by observing maternal and newborn post-delivery outcomes prior to discharge.
  
  
  RESULTS
  Koohi Goth Vacuum Delivery System was applied to 137 women requiring instrumental delivery, of whom 111 (81%; 95% CI = 74-88%) successfully expelled the foetal head assisted by KGVDS and 103 (75%) stated that they would agree to use KGVDS again. There were no serious maternal or neonatal injuries or infections related to KGVDS use. The mean score for 'ease of use' given by doctors and midwives using the device was 8 of 10.
  
  
  CONCLUSIONS
  Koohi Goth Vacuum Delivery System was feasible and safe to use for assisting complicated deliveries in low-resource hospitals in this initial evaluation. Our results indicate that this new device may have the potential to improve birth outcomes in settings where most mortality occurs and that further evaluations should be conducted.
authors.affiliation: Pakistan National Forum on Women's Health, Karachi, Pakistan; London School of Hygiene and Tropical Medicine, London, UK.
authors.forename: Mishal
authors.initials: M
authors.lastname: Khan
authors.forename: Farah Naz
authors.initials: FN
authors.lastname: Hashmani
authors.forename: Sajjad
authors.initials: S
authors.lastname: Ahmed
authors.forename: Owais
authors.initials: O
authors.lastname: Ahmed
authors.forename: Shabnam S
authors.initials: SS
authors.lastname: Asim
authors.forename: Yasmin
authors.initials: Y
authors.lastname: Wajahat
authors.forename: Shoaib
authors.initials: S
authors.lastname: Sobani
authors.forename: Shershah
authors.initials: S
authors.lastname: Syed
authors.forename: Fahad
authors.initials: F
authors.lastname: Qazi
mesh_terms: D000328:Adult; D004869:Equipment Safety; D005240:Feasibility Studies; D005260:Female; D006295:Health Resources; D006801:Humans; D007744:Obstetric Labor Complications / Q000628:therapy*; D010154:Pakistan; D011247:Pregnancy; D011446:Prospective Studies; D016896:Treatment Outcome; D014620:Vacuum Extraction, Obstetrical / Q000295:instrumentation*; D055815:Young Adult
keywords: emplazamiento con pocos recursos; low-resource setting; maternal health; milieux à faibles ressources; salud materna; santé maternelle